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Hot flashes in men with prostate cancer

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Title:
Hot flashes in men with prostate cancer prevalence, severity, and psychosocial correlates
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Winters, Erin
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University of South Florida
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Androgen deprivation
Fatigue
Sleep
Depression
Catastrophizing
Dissertations, Academic -- Psychology -- Doctoral -- USF
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bibliography   ( marcgt )
theses   ( marcgt )
non-fiction   ( marcgt )

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Abstract:
ABSTRACT: The present study evaluated the prevalence, severity, and psychosocial correlates of hot flashes in men receiving androgen deprivation therapy for prostate cancer. Seventy-two men completed a detailed packet of questionnaires prior to the initiation of treatment and again three-months later. Results indicated that the extent to which hot flashes interfered with patients' daily functioning significantly contributed to changes in depressive symptoms. Changes in fatigue were found to mediate the relationship between hot-flash related interference and depressive symptomatology, suggesting that increases in fatigue were responsible for the concurrent increases in symptoms of depression. The coping strategy of catastrophizing moderated the relationship between hot flash-related interference and cancer-related distress, such that levels of cancer-related distress in men reporting greater use of catastrophizing were dependent upon levels of hot flash-related interference. Men who did not engage in catastrophizing reported uniformly low levels of cancer-related distress regardless of the extent to which hot flashes interfered with daily functioning. Expected relationships between hot flashes and sexual functioning or masculine self-image were not confirmed. These findings provide valuable information regarding the experience of hot flashes in this population. Results indicate that reduction of fatigue may lead to reductions in depressive symptoms, while reducing patients' use of catastrophizing may alleviate cancer-related distress.
Thesis:
Dissertation (Ph.D.)--University of South Florida, 2006.
Bibliography:
Includes bibliographical references.
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Statement of Responsibility:
by Erin Winters.
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Title from PDF of title page.
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Document formatted into pages; contains 121 pages.
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Includes vita.

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aleph - 001797669
oclc - 156998126
usfldc doi - E14-SFE0001632
usfldc handle - e14.1632
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Hot flashes in men with prostate cancer :
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ABSTRACT: The present study evaluated the prevalence, severity, and psychosocial correlates of hot flashes in men receiving androgen deprivation therapy for prostate cancer. Seventy-two men completed a detailed packet of questionnaires prior to the initiation of treatment and again three-months later. Results indicated that the extent to which hot flashes interfered with patients' daily functioning significantly contributed to changes in depressive symptoms. Changes in fatigue were found to mediate the relationship between hot-flash related interference and depressive symptomatology, suggesting that increases in fatigue were responsible for the concurrent increases in symptoms of depression. The coping strategy of catastrophizing moderated the relationship between hot flash-related interference and cancer-related distress, such that levels of cancer-related distress in men reporting greater use of catastrophizing were dependent upon levels of hot flash-related interference. Men who did not engage in catastrophizing reported uniformly low levels of cancer-related distress regardless of the extent to which hot flashes interfered with daily functioning. Expected relationships between hot flashes and sexual functioning or masculine self-image were not confirmed. These findings provide valuable information regarding the experience of hot flashes in this population. Results indicate that reduction of fatigue may lead to reductions in depressive symptoms, while reducing patients' use of catastrophizing may alleviate cancer-related distress.
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H otFlashesinMenwithProstateCancer:Prevalence,Severity,andPsychosocial Correlates by ErinWinters Adissertationsubmittedinpartialfulfillment oftherequirementsforthedegreeof DoctorofPhilosophy DepartmentofPsychology CollegeofArts&Sciences UniversityofSouthFlorida MajorProfessor:PaulB.Jacobsen,Ph.D. StephenG.Patterson,M.D. WilliamP.Sacco,Ph.D. KristenSalomon,Ph.D. J.KevinThompson,Ph.D. DateofApproval: May22,2006 Keywords:androgendeprivation,fatigue,sleep,depression,catastrophizing Copyright2006,ErinWinters

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A cknowledgements ThisprojectcouldnothavebeenaccomplishedwithouttheguidanceandsupportofPaul Jacobsen,Ph.D.,mygraduateadvisorandresearchmentor.Additionalthanksaredueto mydissertationcommitteemembers,WilliamSacco,Ph.D.,KevinThompson,Ph.D., KristenSalomon,Ph.D.,andStephenPatterson,M.D.forthethoughtfulsuggestionsthat havehelpedtomakethisastrongermanuscript.Finally,Iwouldliketoexpressdeep gratitudetoRaoulSalup,M.D.,oftheJamesA.HaleyVeteransHospitalforvastly expandingmyknowledgeaboutprostatecancerandforassistingimmeasurablyinmy datacollectionefforts.Inadditiontothosewhohaveaidedinmyprofessional development,Iwouldalsoliketoexpressmyappreciationforthosewhohavehelpedto providebalanceinmypersonallife.Tomyhusband,Cesar,thankyouforbeingmyrock throughoutthemajorityofmygraduateschoolcareer.Lastbutnotleast,aspecialthank youtomyparents,JoanandLarryWinters,foryourunwaveringsupportinmypursuitof mygoals.

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Not etoReader NotetoReader:Theoriginalofthisdocumentcontainscolorthatis necessaryforunderstandingthedata.Theoriginaldissertationisonfile withtheUSFlibraryinTampa,Florida.

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i T ableofContents ListofTables iii ListofFigures v Abstract vi Introduction 1 Hotflashesandhormonaltherapy 2 Sideeffectsandrelatedpsychosocialsequelaeofhormonaltherapy 3 Psychosocialfactorsassociatedwithhotflashesinwomenwithbreast cancer 11 Potentialmediatorsandmoderatorsoftherelationshipbetweenhot flashesandemotionaldistress 13 Rationaleandaims 19 Method 22 Participants 22 Procedure 22 Measures 23 Demographicdata 23 Diseaseandtreatmentvariables 23 Hotflashes 23 Hotflashinterference 24 Fatigue 25 Sleepquality 25 Depressivesymptomatology 26 Cancer-relateddistress 26 Masculineself-image 27 Catastrophizing 27 Qualityoflife 28 Results 30 Participantcharacteristics 30 Participantsexperienceofhotflashes 35 Preliminaryanalyses 36 Relationshipbetweenhotflashesanddistress 45 Relationshipbetweenhotflashes,fatigue,sleepproblemsandsexual functioning 48

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ii R elationshipbetweenfatigue,sleepproblems,sexualfunctioning,and psychologicaldistress 52 Testsofmediation 56 Testsofmoderation 59 Discussion 65 References 74 Appendices 81 AppendixA:InformedConsentforMoffittCancerCenter 82 AppendixB:InformedConsentforJamesA.HaleyVeteransHospital85 AppendixC:ResearchAuthorizationforMoffittCancerCenter 91 AppendixD:ResearchAuthorizationforJamesA.HaleyVeterans Hospital 96 AppendixE:GeneralBackgroundInformation 98 AppendixF:HotFlashQuestionnaire 102 AppendixG:HotFlash-RelatedDailyInterferenceScale 103 AppendixH:FatigueSymptomInventory 104 AppendixI:PittsburghSleepQualityIndex 107 AppendixJ:CenterforEpidemiologicalStudies-DepressionScale 108 AppendixK:ImpactofEventsScale 110 AppendixL:BemSexRoleInventory-ShortForm 112 AppendixM:HotFlashCatastrophizingScale(Baseline) 114 AppendixN:HotFlashCatastrophizingScale(3MonthFollow-Up)115 AppendixO:ExpandedProstateCancerIndexComposite 116 AbouttheAuthor EndPage

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iii Li stofTables Table1ComparisonofDemographicandClinicalVariablesbetween StudyParticipantsandNon-Participants 31 Table2DemographicCharacteristicsoftheStudySample 32 Table3ClinicalCharacteristicsoftheStudySample 34 Table4CorrelationsbetweenDemographicandClinicalVariablesand PredictorVariables 37 Table5CorrelationsbetweenDemographicandClinicalVariablesand OutcomeVariables 38 Table6CorrelationsbetweenDemographicandClinicalVariablesand PotentialMediatingVariables 39 Table7CorrelationsbetweenDemographicandClinicalVariablesand PotentialModeratingVariables 40 Table8DescriptiveandUnivariateStatisticsforPsychosocialVariables42 Table9CorrelationMatrixofStudyVariablesatBaselineand Three-MonthFollow-Up 43 Table10CorrelationsbetweenHotFlashVariablesandPsychological DistressVariablesatThree-MonthFollow-Up 45 Table11RegressionAnalysesofHotFlashVariablesonDepressive SymptomatologyatThree-MonthFollow-Up 46 Table12RegressionAnalysesofHotFlashVariablesonCancer-Related DistressatThree-MonthFollow-Up 48 Table13CorrelationsbetweenHotFlashVariablesandFatigue,Sleep Problems,andSexualFunctioningandThree-MonthFollow-Up49 Table14SummaryofRegressionAnalysesofMostFatigueatThree-Month Follow-Up 50

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iv T able15SummaryofRegressionAnalysesofSleepProblemsatThreeMonthFollow-Up 51 Table16SummaryofRegressionAnalysesofSexualFunctioningatThreeMonthFollow-Up 52 Table17CorrelationsbetweenPsychologicalDistressVariablesand Fatigue,SleepProblems,andSexualFunctioningatThree-Month Follow-Up 53 Table18RegressionAnalysesofPotentialMediatorsonDepressive SymptomatologyatThree-MonthFollow-Up 54 Table19RegressionAnalysesofPotentialMediatorsonCancer-Related DistressatThree-MonthFollow-Up 55 Table20EvaluationofChangesinMostFatigueandSleepProblemsas MediatorsoftheRelationshipbetweenHotFlash-Related InterferenceandChangesinDepression 58 Table21EvaluationofMasculineSelf-ImageasaModeratorofthe RelationshipbetweenHotFlashExperienceandDepressive Symptomatology 60 Table22EvaluationofCatastrophizingPotentialasaModeratorofthe RelationshipbetweenHotFlashExperienceandDepressive Symptomatology 61 Table23EvaluationofMasculineSelf-ImageasaModeratorofthe RelationshipbetweenHotFlashExperienceandCancer-Related Distress 62 Table24EvaluationofCatastrophizingPotentialasaModeratorofthe RelationshipbetweenHotFlashExperienceandCancer-Related Distress 63

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v L istofFigures Figure1.ModeloftheRelationshipbetweenHotFlash-RelatedInterference andDepressiveSymptomatologyasMediatedbyFatigueand SleepProblems 57 Figure2.EffectofHotFlash-RelatedInterferenceonCancer-Related DistressbyCatastrophizingPotential 64

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vi H otFlashesinMenwithProstateCancer:Prevalence,Severity,andPsychosocial Correlates ErinWinters ABSTRACT Thepresentstudyevaluatedtheprevalence,severity,andpsychosocialcorrelates ofhotflashesinmenreceivingandrogendeprivationtherapyforprostatecancer. Seventy-twomencompletedadetailedpacketofquestionnairespriortotheinitiationof treatmentandagainthree-monthslater.Resultsindicatedthattheextenttowhichhot flashesinterferedwithpatientsdailyfunctioningsignificantlycontributedtochangesin depressivesymptoms.Changesinfatiguewerefoundtomediatetherelationshipbetween hot-flashrelatedinterferenceanddepressivesymptomatology,suggestingthatincreases infatiguewereresponsiblefortheconcurrentincreasesinsymptomsofdepression.The copingstrategyofcatastrophizingmoderatedtherelationshipbetweenhotflash-related interferenceandcancer-relateddistress,suchthatlevelsofcancer-relateddistressinmen reportinggreateruseofcatastrophizingweredependentuponlevelsofhotflash-related interference.Menwhodidnotengageincatastrophizingreporteduniformlylowlevelsof cancer-relateddistressregardlessoftheextenttowhichhotflashesinterferedwithdaily functioning.Expectedrelationshipsbetweenhotflashesandsexualfunctioningor masculineself-imagewerenotconfirmed.Thesefindingsprovidevaluableinformation regardingtheexperienceofhotflashesinthispopulation.Resultsindicatethatreduction

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vii o ffatiguemayleadtoreductionsindepressivesymptoms,whilereducingpatientsuseof catastrophizingmayalleviatecancer-relateddistress.

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1 Al thoughhotflashesareacommonlyrecognizedsideeffectofhormonaltherapy forprostatecancer,limitedresearchexiststodescribethepsychosocialimpactofthis gender-inconsistentexperience.Othersideeffectsofprostatecancertreatment,suchas sexual,urinary,andbowelimpairmenthavereceivedgreaterattentionintermsoftheir impactondailyfunctioningandqualityoflife.Thepurposeofthecurrentinvestigationis toidentifythepsychosocialcorrelatesofhotflashesinmenwithprostatecancer undergoinghormonaltherapyandtoidentifypotentialmediatorsandmoderatorsofthe relationshipbetweenhotflashesandpsychologicaldistress.Theintroductionbeginswith backgroundinformationontheroleofhormonaltherapyinthetreatmentofprostate cancer.Thissectionincludesinformationabouttheprevalenceofhotflashesinmenwith prostatecancerandabriefexplanationofhowhotflashescanbeinducedbyhormonal therapy.Areviewoftheliteraturethathasassessedthecommonsideeffectsofhormonal treatmentfollows.Muchofthisresearchhasfocusedontheroleofhormonaltherapyin producingdecrementsinsexualfunctioningandoverallqualityoflife.Becauserelatively littleresearchhasbeenconductedonhotflashesinmenwithprostatecancer,discussion willthenturntoresearchthathasinvestigatedtheimpactofhotflashesinwomenwith breastcancer.Correlatesandpredictorsofhotflashesinthispopulationwillbe highlightedastheymayapplytomenwithprostatecancer.Theintroductionconcludes withadiscussionofvariablesthatmightserveasmediatorsandmoderatorsofthe relationshipbetweenhotflashesandpsychologicaldistress.

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2 Hot flashesandhormonaltherapy Althoughhotflashesaretypicallyregardedasanaturallyoccurringsymptomof femalemenopause,mentreatedwithhormonaltherapyforprostatecanceralso experiencehotflashes.Asignificantnumberofmenundergoingthisformoftreatment havereportedexperiencinghotflashes,withestimatesrangingfrom57%(Potoskyet.al., 2001)to74%(Spetz,Hammar,Lindberg,et.al.,2001).Becausehotflashesandtheir associateddistressareprevalentinthispatientpopulation,itisimportanttounderstand thephenomenonandthefactorsassociatedwithit.Ahotflashhasbeendefinedas,a transientepisodeofflushing,sweating,andasensationofheat,oftenaccompaniedby palpitationsandafeelingofanxiety,andsometimesfollowedbychills(Kronenberg, 1994,p.320).Thisexperiencemayvaryfrompersontopersonintermsoffrequency, severity,andduration.Hotflashesareaconsequenceofreductionsinestradiol,which canresultfromnaturalmenopause,removaloftheovariesortestes,oruseofhormone agonistsorantagonists(Fitzpatrick&Santen,2002).Lutenizinghormone-releasing hormone(LHRH)agonistsarethemostfrequentlyusedoftheseagentsandhave revolutionizedthetreatmentofadvancedprostatecancer.Useofthesehormonalagents causesachainofeventsinthebodythateventuallyleadstoadecreaseintestosterone production(Hellerstedt&Pienta,2002).Thisaccomplishesthegoalofslowingthe growthofthecancer,butalsoproducesseveralunwantedeffects,includinghotflashes. Thepurposeofhormonaltherapyinmenwithprostatecanceristodecreasethe productionoftestosteronebythetestesortoblocktheactionoftestosteroneonthe prostatecells.Thiscanbeaccomplishedsurgically,byremovalofthetestes (orchiectomy)ormedically,byinjectingdrugsthatpreventproductionoftestosteroneby

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3 t hetestes.Hormonaltherapyisnotacureforprostatecancer,butratherameansof slowingitsgrowthandreducingthesizeofthetumor.Hormonaltherapy,orandrogen deprivationtherapyasitisoftenreferredto,isusedtotreatpatientswithvaryingstages ofdisease.Intheearlystagesofaprostatecancerdiagnosis,hormonaltherapymaybe prescribedinmenwithlargeprostateglandsasameansofreducingthesizeofthe prostateinpreparationforbrachytherapyorradiation.Atthelaterstagesitcanbeusedto treatmenconsideredtobebiochemicalfailures,inthatthefirstlinetreatment (prostatectomy,radiation,orbrachytherapy)didnotcompletelyeliminatethecancerous cells(Dreicer,2002).ThisisevidencedbyasteadyriseinpatientsPSAvalues,whichis consideredtobeindicativeofprogressivedisease.Becauseoftheminimalburdenonthe patient,ascomparedtoprostatectomyorradiation,thisformoftreatmentisoften attractivetothosepatientsandclinicianswhowouldprefertotakeaslightlymoreactive rolethanthepassiveoptionofwatchfulwaiting. Sideeffectsandrelatedpsychosocialsequelaeofhormonaltherapy Existingresearchwithmenreceivingandrogendeprivationtherapyhasfocused mainlyontheprevalenceof,andbotherassociatedwith,thesideeffectsofthisformof treatment.Recognizedsideeffectsincludelossoflibidoanderectiledysfunction,hot flashes,gynecomastia,weightgain,osteoporosis,anemia,changesinmoodandcognitive function,fatigue,anddiminishedqualityoflife(Chen&Petrylak,2004).Thefollowing sectionwillreviewtherecentliteraturethatexaminestherelationshipbetweenuseof androgendeprivationtherapyandqualityoflife.Researchfocusingspecificallyonthe roleofhotflashesinmenissomewhatsparse.Thefewstudiesconductedhavebeen

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4 l argelydescriptiveinnatureandhavenotattemptedtosystematicallyexplorethe psychosocialcorrelatesofhotflashes. Spetzandcolleagues(2001)comparedsurvivalandqualityoflifeoutcomesin menwithmetastaticprostatecancerrandomlyassignedtoreceiveinjectionsof polyestradiolphosphate(asemi-syntheticestrogen)orundergocompleteandrogen ablationviabilateralorchiectomyorinjectionofLHRHagonists.Thisinvestigationis notableforitsfocusonhotflashesandtheuseofrandomizationtotreatmentgroups.Ata follow-upassessment(mediantime=twoyears)74%ofpatientsintheandrogenablation groupwereexperiencinghotflashescomparedto30%ofpatientsinthepolyestradiol phosphategroup.Menintheandrogenablationgroupalsoreportedexperiencing significantlymoredistressasaresultofthehotflashes.Withinthetwo-yearfollowup period,halfthemenreceivingpolyestradiolphosphatewerenolongerexperiencinghot flashes,yetallthemenonandrogenablationwerestillexperiencinghotflashestosome degree.Thesefindingsindicatethathotflashesarenotatransientsideeffect,aswasonce believed. TheProstateCancerOutcomesStudy(PCOS)isalarge-scalesurveyofnewly diagnosedprostatecancerpatients.Usingasubsetofthesedata,Potoskyandcolleagues (2001)comparedqualityoflifeoutcomesformenreceivingprimaryandrogen deprivationviasurgicalcastration(orchiectomy)versuschemicalcastration(LHRH agonists).Thesemendidnotreceiveanyotherformoftreatmentwithinthefirst12 monthsoftheirdiagnosis.Datawerecollectedatsixand12monthsaftertreatment.The rateofhotflashesdidnotdiffersignificantlybetweenthetwotreatmentgroups,with 57%ofmentreatedwithLHRHagonistsand68%ofmentreatedwithanorchiectomy

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5 r eportingthissideeffect.Althoughtherewerenodifferencesbetweenthetwogroupsin self-reportedsexualfunctioning,significantoveralldeclineswereobservedinseveral domains.Ofthemenwhoreportednormalpretreatmentsexualfunctioning,69%were impotentaftertreatment.Additionally,51%ofthemenwithsomeinterestinsexpriorto treatmentreportedacompletelackofinterestafterwardsand73%ceasedtoengagein sexualactivitycompletely. AnoverallweaknessofthePCOSistheuseofretrospectivereportsofbaseline (i.e.,pretreatment)functioning.Participantswerecontactedsixmonthsafterdiagnosis,at whichtimetheywereinstructedtorecalltheirhealthstatusasitwaspriortotreatment. Althoughstepsweretakentoexaminerecallaccuracy(Legler,Potosky,Gilliland,Eley, &Stanford,2000),thepotentialforrecallbiascannotbeeliminatedcompletely. Additionally,thestudyhadanoverallresponserateof62%,withnon-respondersbeing morelikelytobenonwhiteandoflowersocioeconomicstatusthanresponders(Potosky etal,1999).Therefore,generalizationtononwhiteandlowersocioeconomicstatus patientsmustbemadewithcaution.Finally,itisunclearwhetherpatientschosethese therapiesbecauseofpersonalpreferencesorwereadvisedtodosoundertheguidanceof theironcologists.Withoutrandomassignment,thepotentialconfoundinginfluenceof variablesotherthantreatmentontheexperiencesideeffectscannotberuledout. AnotheranalysisbasedondatafromthePCOScomparedmenreceivingandrogen deprivationtherapyastheirprimaryformoftreatmentwithmenreceivingnotreatment, otherwiseknownaswatchfulwaiting(Potoskyet.al.,2002).Findingsindicatedthat amongmenwhoreportednormalsexualfunctioningatbaseline,menwhohadreceived androgendeprivationtherapyreportedlessinterestinsex,morebreastswelling,anda

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6 gr eaternumberofhotflashesoneyearaftertreatmentcomparedtothosefollowedby watchfulwaiting.Menreceivingandrogendeprivationtherapyalsoreportedhigher levelsofphysicaldiscomfortduetoprostatecancer,aswellasmorephysicallimitations andgreaterbotherattributedtothedisease.Aswiththepreviousstudy,methodological limitationsincludedretrospectiverecallofbaselinefunctioning,differentialresponse ratesforageandSES,andnon-randomassignmenttotreatmentgroups.Another confoundingvariablewascancerseverity.Itshouldbenotedthatreceiptofandrogen deprivationtherapywasassociatedwithseveralindicatorsofmoreadvanceddisease, includinghigherGleasonscores,higherPSAvalues,andahigherlevelofstaging.The greaterdiscomfortandpoorerphysicalfunctioningreportedbyandrogen-deprivedmen mayhavebeenpartiallyduetotheprostatecanceritselfratherthanthetreatmentreceived bythesemen. Otherresearchinthisareahasyieldedsimilarfindingsregardingtheadverseside effectsofandrogendeprivationtherapy.HerrandOSullivan(2000)surveyedagroupof menwithrisingPSAsafterlocaltherapy.Thissamplewasobtainedbyrecruitingfrom attendeesataprostatecancersupportgroup.Thesemenhadbeenofferedthechoiceof immediateandrogendeprivationtherapy(eitherorchiectomyoradministrationofLHRH agonists)orobservationwithdeferredandrogendeprivationtherapy.Menwhohad chosentoreceiveimmediateandrogendeprivationtherapyreportedgreaterfatigue,worse physicalfunctioning,greaterpsychologicaldistress,greatersexualproblems,andlower overallqualityoflifethanmenwhochoseobservation.Furthercomparisonsrevealedthat menwhooptedforandrogendeprivationtherapyusingLHRHagonistsreportedagreater numberofproblemsthandidthemenwhohadanorchiectomy.Specifically,they

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7 r eportedaloweroverallqualityoflife,greaterpsychologicaldistress,agreaternumberof cancer-relatedintrusivethoughts,andgreaterfatigue.Hotflasheswerenotassessed. Whenconsideringtheresultsofthisstudyitisimportanttokeepinmindthatthesample usedwasself-selected.Participantswererecruitedfromaprostatecancereducational supportgroupconductedbytheauthors.Thewaysinwhichthesemenmaydifferfrom prostatecancerpatientsnotattendingasupportgroupisunknown.Additionally,these menwerenotrandomlyassignedtoreceiveandrogendeprivationtherapy,butwereable tochoosewhichtreatmenttoreceive.Thepossibilityexiststhatsomeoftheobserved differencesmayreflectcharacteristicsofthementhemselvesratherthantheimpactofthe treatmenttheychose. Androgendeprivationtherapyisalsousedtotreatprostatecancerpatientswith metastaticdisease.Despitethefactthatthediseaseismorewidespread,thesemenreport similarproblems.Herr,Kornblith,andOfman(1993)assessedpatientswithmetastatic diseasewhochosetoreceiveordeferhormonaltherapy.Patientswhochosehormonal therapyreportedlesssexualinterestandenjoyment,increasedfatigue,andagreater numberofphysicalsymptomsatasix-monthfollow-upassessment.Althoughthebattery ofquestionnairesusedincludedanitemassessinghotflashes,theresultsforthisitem werenotreported.Becauseofthenonrandomnatureofthestudy,theseresultsmustbe interpretedwithcaution. Fowlerandcolleagues(2002)comparedqualityoflifeinmentreatedwith androgendeprivationafterprostatectomyandmentreatedwithprostatectomyalone. Treatmentsideeffectsexaminedincludedurinaryincontinence,erectiledysfunction,and lossoflibido.Mentreatedwithandrogendeprivationreportedlessabilitytohavesexual

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8 i ntercourseandfewerdaysoffeelingsexualdrivethanmentreatedwithprostatectomy alone.Analysesregardingqualityoflifewereperformedbothwithandwithoutmenwith metastaticdiseaseinordertoexaminetheroleoftherecurrenceitself.Resultsofboth analysesweresimilar.Menwhohadreceivedandrogendeprivationtherapyreportedthat canceranditstreatmenthadabiggernegativeeffectontheirlives,reportedmore concernsaboutbodyimage,andreportedmoreworriesaboutdeathanddyingthanmen whodidnotreceiveandrogendeprivationtherapy.Additionally,theyreportedworse scoresonindicesofmentalhealth,generalhealth,andactivity.Weaknessesofthisstudy includedtheuseofquestionnairesthathadnotbeenpreviouslyvalidated,acrosssectionaldesign,andnon-randomassignmenttotreatmentgroups. Otherresearchsuggeststhatcomparedtootherformsoftreatment,androgen deprivationtherapymaybeassociatedwithmorelongstandingdeclinesinhealth-related qualityoflife.Lubeck,Grossfeld,andCarroll(2001)evaluatedseveralaspectsofquality oflifeinmentreatedwithprostatectomy,radiation,androgendeprivationtherapy,or surveillanceaspartoftheCanceroftheProstateStrategicUrologicEndeavor (CaPSURE).SimilartothePCOS,CaPSUREisanationallongitudinalstudyofmenwith prostatecancer.Thetimingofthefirstassessmentvariedbaseduponthetimeof enrollmentinthestudy.Forsomementhiswaspriortotheinitiationofanytypeof therapy,forothersitwassometimeafterwards.Sexual,urinary,andbowelfunction wereassessed,butevaluationofhotflasheswasnotwithinthescopeofthisstudy.Ofthe manyareasofheath-relatedqualityoflifeassessed,menonandrogendeprivationtherapy experiencedsignificantdeclinesinsexualfunctionandsexualbotheronly.Ascompared tomenintheotherthreetreatmentgroup,menreceivingandrogendeprivationtherapy

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9 gr ouphadthehighestpercentageofpatientswithadvanceddisease.Theresearchersalso analyzedasubsetofthedatafrommenwhohadcompletedthequestionnairesbeforeand afterinitiationofandrogendeprivationtherapy.Significantdecrementswerefoundin sexualfunctioningsixmonthsaftertreatmentbegan.Strengthsofthisinvestigation includedtheuseofwell-establishedtoolstoassessbothgeneralandhealth-relatedquality oflife.Thelackofrandomizationtotreatmentconditionsprohibitsfirmconclusions regardingthechangesinqualityoflifeduesolelytotreatment. Inanattempttoprovideinformationregardingtheprevalence,severity,and correlatesoffatigueinmenreceivinghormonaltherapy,Stoneandcolleagues(2000) assessed62menwithprostatecancerpriortoandthreemonthsafterinitialreceiptofan LHRHanalogue.Atthethree-monthassessment,66%ofpatientsreportedanincreasein fatigue,with42%ofmenreportinganincreaseof10pointsormore(onascaleranging from9-63).Seventeenpercentofmenmetthecriteriacorrespondingtoseverefatigue. Althoughtherewasastrongrelationshipbetweenfatigueandpsychologicaldistressat thebaselineassessment,theincreaseinfatiguewasnotassociatedwithaconcurrent increaseindistress.Pre-treatmentmeasuresoffatigueaccountedfor32%ofthevariance infatiguescoreatthethree-monthfollow-up.Noneoftheothervariablesassessed (qualityoflife,functionalabilities,psychologicaldistress,nutritionalstatus,other symptomseverity)weresignificantpredictorsoffatiguelevelsthreemonthsafterthe initialinjection. Inaninvestigationfocusingonratesofdepressioninmenreceivingandrogen deprivationtherapy,Pirlandcolleagues(2002)reportedaprevalencerateof12.8%as assessedbytheStructuredClinicalInterviewfortheDSM-IV(SCID).Similarly,13.3%

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10 o fpatientsreportedsymptomsconsistentwithamildtomoderatelevelofdepressionon theBeckDepressionInventory(BDI).Inthissample,ratesdidnotdifferbydisease stage,methodofandrogendeprivation(orchiectomyvs.GnRHagonist),androgen dependence,orwhetherornotthepatientwasalsoreceivingchemotherapy.Not surprisingly,apriorhistoryofdepressionwasassociatedwithreportsofcurrent depressivesymptomology.Becausehistoryofdepressivesymptomswasassessed retrospectively,fluctuationsinlevelofdistressduetochangesinhormonalstatescould notbedetermined.Greaterlevelsofdepressivesymptomswerecorrelatedwithincreased fatigueandlowerlevelsoffunctioning.Althoughthisstudyhadasmallsamplesize(N= 45),ithighlightstheneedforappropriateattentiondevotedtoassessmentanddiagnosis ofdepressioninthispatientpopulation. InasampleofJapanesepatientstreatedwithandrogendeprivationtherapy, approximately58%reportedexperiencinghotflashes,ofwhich38%chosetopursue treatmentforthistroublingsideeffect(Nishiyama,et.al.,2004).Patientswithand withouthotflashesdifferedintermsofphysicalwell-being,social/familywell-being, health-relatedqualityoflife,andoverallqualityoflife.Menwithhotflashesreported moreproblemsineachoftheseareas.Thisstudysufferedfromseveralmethodological limitations,includingasmallsamplesize(N=55),cross-sectionaldata,anda heterogeneoussample;however,itwastheonlystudyfoundthatattemptedtoevaluate changesinqualityoflifeduetohotflashes. Thefindingsreviewedaboveoutlinemanyofthedecrementsinqualityoflifethat areassociatedwithhormonaltherapyforprostatecancer.Menreceivingthisformof treatmentoftenreportdeclinesinsexualfunctioningandinterest,increasedfatigue,hot

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11 f lashes,anddeclinesinoverallperceivedphysicalhealth.Theyalsoreportasignificant amountofpsychologicaldistressanddeclinesinseveralaspectsofqualityoflife. Comparedtomentreatedwithprostatectomy,mentreatedwithhormonaltherapyreport greaterconcernsoverbodyimage,worryaboutdeathanddying,anddistressdueto prostatecancer.Althoughhotflashesarearecognizedsideeffectofthisformof treatment,relativelylittleattentionhasbeenpaidtotheirpsychosocialimpact. Psychosocialfactorsassociatedwithhotflashesinwomenwithbreastcancer Withinthefieldofoncology,muchoftheresearchonhotflashesandtheirimpact onqualityoflifehasbeenconductedinwomenwithbreastcancer.Inadditionto naturallyoccurringmenopause,womenwithbreastcancermaybesusceptibletohot flashesduetosurgically-inducedmenopauseviaremovaloftheovaries(oophorectomy) orchemotherapy-inducedmenopause.Someoftheresearchonhotflashesinwomenwith breastcancerwillbediscussedasitmayalsopertaintomenwithprostatecancer. Basedonstructuredtelephoneinterviewsconductedwithpostmenopausalwomen withbreastcancer,Carpenterandcolleagues(1998)foundthat65%reportedhotflashes. Moreseverehotflasheswereassociatedwithahigherbodymassindex(BMI),younger age,anduseoftamoxifen(ananti-estrogenicagent).Comparisonswerealsomade betweenwomenwithandwithouthotflashesonqualityoflifevariables.Althoughnone ofthecomparisonsreachedthecriterionsetforstatisticalsignificance,therewasatrend forwomenwithhotflashestoreportpoorermentalandphysicalqualityoflife.Asimilar trendwasfoundfordifferencesbetweenwomenwithnohotflashesormildhotflashes andthosewithseverehotflashes.Withtheexceptionoftamoxifenuse,thepsychosocial correlateslistedabovemayalsobeapplicabletomenwithprostatecancer.

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12 St einandcolleagues(2000)exploredthemedical,psychosocial,anddemographic correlatesofhotflashesinasampleofwomencurrentlyundergoingbreastcancer treatment.Intermsofpsychosocialvariables,womenexperiencinghotflashesreported higherlevelsoffatigue,greaterinterferenceoffatiguewithqualityoflife,poorersleep quality,andpoorerphysicalhealth.Moreseverehotflasheswereassociatedwithgreater fatigue,poorerphysicalhealth,agreaterimpactoffatigueonqualityoflife,andhigher levelsofglobalandsomaticsymptomsoffatigue.Inordertodeterminethecontribution ofhotflashprevalencetothevariabilityinpsychosocialandqualityoflifeoutcomes, multipleregressionanalyseswereconducted.Afteraccountingforrelevantmedical, demographic,andtreatmentvariables,hotflashesaccountedforanadditional11%ofthe varianceinphysicalhealth,anadditional15%ofthevarianceinsleepquality,andan additional9%ofthevarianceinfatigue.Thesefindingssuggestthathotflashesplaya significantroleinregardstothedevelopmentandimpactoffatigue. Carpenter,Johnson,Wagner,andAndrykowski(2002)tookthislineofresearcha stepfurtherwiththeadditionofanage-matchedcomparisongroupofhealthywomen. Womenwithbreastcancerweresignificantlymorelikelytobeexperiencinghotflashes thanwomenwithoutbreastcancer.Womenwithbreastcanceralsoreportedsignificantly greaterhotflashseverityandbothercomparedtothehealthywomen.Amongbreast cancersurvivors,greaterseverityofhotflasheswasassociatedwithhigherlevelsof mooddisturbance,negativeaffect,andinterferenceofhotflasheswithqualityoflife. Hotflasheshavealsobeenassessedusingobjectiveassessmentmethods.Ina smallpilotstudy,Carpenterandcolleagues(2004)assessed15breastcancersurvivors and15healthywomenmatchedonage,race,andmenopausalstatus.Hotflasheswere

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13 m easuredusingsternalskinconductancemonitoringduringtwo24-hourperiodsone weekapart.Therewasatrendtowardsagreaternumberofdaytimehotflashesforbreast cancersurvivorsascomparedtotheirhealthycounterparts,butthisdifferencedidnot reachthecriterionsetforsignificance.Whenmeasuredobjectively,frequencyofhot flashesfailedtocorrelatewithsleepdurationandglobalsleepquality.Althoughthis investigationsufferedfromasmallsamplesize,ithighlightsthediscrepantresults obtainedusingobjectivemeasurementofhotflashes. Althoughinformationgatheredfromresearchconductedwithwomenwithbreast cancermaynotdirectlyrelatetomenwithprostatecancer,itsuggestsseveraldomains thatmaybeaffectedbyhotflashes.Psychosocialvariablesassociatedwiththehotflash experienceincludehigherlevelsoffatigue,higherlevelsoffatigueinterferencewith qualityoflife,poorersleepquality,higherlevelsofmooddisturbance,greaternegative affect,poorermentalandphysicalqualityoflife,andgreaterinterferenceofhotflashes withqualityoflife. Potentialmediatorsandmoderatorsofth erelationshipbetweenhotflashesand emotionaldistress Theliteraturereviewedsuggeststhattheexperienceofhotflashesinbothmen andwomenisassociatedwithsomedegreeofpsychologicaldistress(Carpenter,et.al., 1998;Carpenter,et.al.,2002;Fowler,et.al.,2002;Herr&OSullivan,2000;Pirl,et.al., 2002;Spetz,et.al.,2001).Thecurrentstudywilltestthehypothesisthatasimilar relationshipbetweenhotflashesandpsychologicaldistressispresentinmenwith prostatecancerreceivingandrogendeprivationtherapy.Sincetheexperienceofhot flashesisalsoassociatedwithotheradversesymptomsandstates,itshouldbepossibleto

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14 ex plorewhethertheexperienceoftheseadversesymptomsandstatesmediatethe relationshipbetweenhotflashesandpsychologicaldistress.Sleepdisturbance,fatigue, andsexualdysfunctioninparticular,wouldappeartomeritstudyaspotentialmediators fortworeasons.First,thereisevidencetosuggestthattheexperienceofhotflashesis associatedwithsleepproblemsandfatigue(Steinet.al.,2000),aswellassexual dysfunction(Carpenteret.al.,2002).Second,thereisevidencetosuggestthatthe experienceofsleepproblems,fatigue(Broeckelet.al.,1998;Stoneet.al.,2000),and sexualproblems(Potoskyet.al.,2001),areassociatedwithpsychologicaldistress. Inadditiontoexaminingpotentialmediatorsoftherelationshipbetweenhot flashesandpsychologicaldistress,thepresentstudywillalsoexaminepotential moderatorsoftherelationshipbetweenhotflashesanddistress.Thatis,thecurrentstudy willseektoidentifyvariablesthatmayinteractwiththeexperienceofhotflashesto producegreaterpsychologicaldistress.Ofparticularinterestaremasculineself-image andthecopingprocessofcatastrophizing. Becausehotflashesaretypicallyafemaleexperience,menwithastrong masculineself-imagemaybemoredistressedbytheexperiencethanthosewhoareless stereotypicalinthewaytheydefinethemselves.Thisideaispartiallysupportedby researchsuggestingthatstrongadherencetothedominantformofmasculinityinthe UnitedStatesmayposeserioushealthrisksformen(Sabo,2000;Sabo&Gordon,1995). Incontrasttoothersideeffectsofprostatecancertreatment,suchasimpotenceor incontinence,hotflashesarenotanexperiencehadbyotheragingmenandarelikelyto beconsideredassomethingonlywomenexperience.Therefore,menwithstrong masculineself-conceptsmaybeparticularlydistressedbyhotflashes.Althoughtherehas

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15 b eenalimitedamountofresearchregardingtheroleofmasculinityincopingwith prostatecancer,somestudieshaveexploredthisconstruct. Galbraith,Ramirez,andPedro(2001)comparedhealth-relatedqualityoflife, healthstatus,andmasculinityinmenundergoingvariousformsoftreatmentforprostate cancer.Thesemenwereinoneoffourtreatmentgroups:watchfulwaiting,conventional radiation,proton-beamradiation,andacombinationofconventionalandproton-beam radiation.MasculinitywasassessedusingtheBemSexRoleInventory.Participantsrated howtrueeachcharacteristicwasofthem,andalsoratedhow important each characteristicwastothem,inordertoassesstheimportanceofsex-roleidentity.Overthe 18-monthstudyperiod,nodifferencesinmasculinitywerefoundamongthefourgroups. Masculinitywassignificantlypositivelyassociatedwithgeneralhealthandsexual symptomsatthebaselineassessment;however,therewasnorelationshipbetween masculineidentityandhealth-relatedqualityoflife.Thisstudydidnotincludemen treatedwithhormonalagents;consequentlytheassociationbetweenhotflashesand masculinitywasnotexplored. Usingfreelists,singlepilesorts,andotheridiographicdatacollectiontechniques, Stansbury,Mathewson-Chapman,andGrant(2003)evaluatedveteransschemas regardingmasculinityandtherelativeimportancegiventogenderattributes.Participants weremenwithprostatecancerandacomparisonsamplemadeupofotherhospital patients(withoutprostatecancer),employees,andvolunteers.Relativetothecomparison group,menwithprostatecancershowedatendencytowardreducedemphasison domesticpower,sexuality,andphysicalaspectsofmasculinity.Theauthorshypothesize thatthistrendmayreflectareformulationoftheirconceptofmasculinitybyreducingthe

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16 i mportanceofcharacteristicsthatmaynolongerapplytothem.Theyacknowledge, however,thattoconfirmthisstatement,theseanalysesmustbeconductedlongitudinally (i.e.,whilepatientsaregoingthroughtreatment),inordertodocumentashiftin conceptualization.Theauthorsalsoproposethatmenwhofailtorevisetheirmasculine conceptwillhaveamoredifficulttimeadaptingtotheconsequencesofprostatecancer treatment.Theysuggestthatmenwhoretaintheirimageofmasculinephysicalityareat thehighestriskforstress,depression,andinterpersonaldifficulties.Althoughthisstudy providedmoretheoreticalinsightthanempiricallysupportedconclusions,itaffirmsthe notionthatamansconceptualizationofmasculinitymayaffecthisreactiontothe consequencesofprostatecancertreatment. Thesecondproposedmoderatoroftherelationshipbetweenhotflashesand distressiscatastrophizing.Intimesofstress,peoplewhocatastrophizeoftenassumethat theworstwillhappenandfeelhelplessandunabletostopthinkingaboutthestressful experience(Sullivan,Bishop,&Pivik,1995).Itishypothesizedthatmenwhoexperience moreseverehotflashesandalsoscorehighlyonameasureofcatastrophizingpotential willreporthigherlevelsofdistress.Althoughcatastrophizinghasbeenlinkedtoavariety ofdeleterioushealthoutcomes,ithasneverbeenexaminedinrelationtothefrequencyor severityofhotflashes.Reviewedbelowareseveralkeyfindingsintheoncology literatureregardingcatastrophizingandotheradversesymptoms. Fivestudiescanbeidentifiedthathaveexaminedtherelationshipbetween catastrophizingandpainratingsincancerpatients.Ofthesefivestudies,threeassessed womenwithbreastcancer(Bishop&Warr,2003;Gaston-Johanssonet.al.,1999; Jacobsen&Butler,1996),oneassessedcancerpatientswithchronicpain(Lin,1998),

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17 an dthefifthassessedlungcancerpatients(Wilkie&Keefe,1991).Threeofthesestudies foundevidenceinsupportofarelationshipbetweengreateruseofcatastrophizingand worsepain(Jacobsen&Butler,1996;Lin,1998;Wilkie&Keefe,1991).Eachstudy utilizeddifferentmethodsofevaluatingpainandcatastrophizing.Althoughthisevidence isfarfromdefinitive,itprovidessomesupportforarelationshipbetweencatastrophizing andcancer-relatedpain. Catastrophizinghasalsobeenfoundtobeassociatedwithfatigueincancerpatient populations.Broeckel,Jacobsen,Horton,Balducci,andLyman(1998)investigatedthe roleofpsychosocialvariablesinpredictingfatigueseverityinasampleofwomenwho hadcompletedchemotherapyforbreastcancer.Alongwithmenopausalsymptom severityandsleepquality,thetendencytoengageincatastrophizingwasasignificant correlateoffatigueseverity.Inmultipleregressionanalyses,catastrophizingaccounted for14%ofthevarianceinfatigueseverityafteraccountingformenopausalsymptom severity. Takingthislineofworkastepfurther,Jacobsen,AzzarelloandHann(1999) exploredtheassociationsbetweencatastrophizingandfatigue,qualityoflife,and emotionaldistressinbreastcancerpatients.Inthissample,ahigherlevelof catastrophizingwasassociatedwithmoreseverefatigue,greaterdepressivesymptoms, higherlevelsofstateanxiety,andpoorerqualityoflife.Catastrophizingwasalsofound toaccountforuniquevarianceindepression,anxiety,andmentalhealthafteraccounting forlevelsoffatigueintensity. Thereisalsoevidencetosuggestthattheimpactofcatastrophizingonfatigue severitymaybespecifictothetypeoftreatmentreceived.Jacobsen,Andrykowski,and

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18 T hors(2004)foundasignificanttreatmentbycatastrophizinginteractioninasampleof 80breastcancerpatients.Inthisstudy,levelofcatastrophizingpredictedsubsequent levelsoffatigueseverityanddisruptivenessamongwomenwhohadreceivedradiation therapy,butnotforwomenwhohadundergonechemotherapy.Theseresultsindicatethat catastrophizingcontributedmoretofatigueseverityamongpatientswhoreceivedtheless inherentlyfatiguingofthetwoformsoftreatment.Basedonthispatternofresults,itwas concludedthatforthechemotherapypatients,theintenselyfatiguingnatureofthe treatmentsupersededtheimpactofanypsychologicalvariables. Takentogether,thefindingsintheoncologyliteraturesuggestthatindividuals whocatastrophizeaboutthesymptomsoftheirillnessorsideeffectsoftreatmentreport higherlevelsofthosesymptomsandsideeffects,andmayalsoexperiencemoredistress asaresult.Althoughthefindingspresentedabovearespecifictopainandfatigue,the relationshipsfoundmaybeequallyapplicabletohotflashes. Asreviewedabove,hotflashesareaprominentsideeffectofhormonaltreatment forprostatecancer.Unlikeothersideeffectsofthistypeoftreatment,hotflashesinmen havereceivedrelativelylittleattentioninthepsychosocialliterature.Becausehotflashes arearelativelyunusualexperienceformen,itisimportanttounderstandthepotential psychosocialsequelae.Thecurrentstudyhopestodrawattentiontothisphenomenonby providinginformationregardingtheprevalenceandseverityofhotflashesinmen receivinghormonaltherapy.Inordertounderstandhowhotflashesmayresultin psychologicaldistress,potentialmediatingandmoderatingrelationshipswillbeexplored.

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19 R ationaleandAims Theaimofthecurrentinvestigationistoexaminethefrequency,severity,and psychosocialcorrelatesofhotflashesinmentreatedwithhormonaltherapyforprostate cancer.Towardthisend,hotflashesandrelevantpsychosocialvariables(described below)wereassessedinagroupofmentreatedwithhormonaltherapyforprostate cancer.Thesevariableswereassessedpriortotheinitiationofhormonaltreatmentand againthreemonthslater.Hotflashprevalence,severity,andinterferencewerealso assessedsixweeksafterthebaselineassessment.Inadditiontocharacterizingthe frequencyandseverityofhotflashesoverathree-monthperiodfollowinginitiationof hormonaltherapy,thecurrentstudyaddressedthefollowinghypotheses: HypothesisSet1:Relationshipofhotflashe stodepressivesymptomatologyandcancerrelated,distress 1A.Aworseexperienceofhotflashes(frequency,severity,score,and/orhotflash-related interference)overthethree-monthperiodwillbeassociatedwithagreaterincreasein cancer-relateddistressasmeasuredbytheImpactofEventsScale(IES). 1B.Aworseexperienceofhotflashesoverthethree-monthperiodwillbeassociated withagreaterincreaseindepressivesymptomatologyasmeasuredbytheCenterfor EpidemiologicalStudiesDepressionScale(CES-D). HypothesisSet2:Relationshipofhotflashexp eriencetosexualdysfunction,fatigue,and sleepdisturbance 2A.Aworseexperienceofhotflashesoverthethree-monthperiodwillbeassociated withagreaterincreaseinfatigueasmeasuredbytheFatigueSymptomInventory(FSI).

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20 2B. Aworseexperienceofhotflashesoverthethree-monthperiodwillbeassociated withagreaterincreaseinsleepdisturbanceasmeasuredbythePittsburghSleepQuality Index(PSQI). 2C.Aworseexperienceofhotflashesoverthethree-monthperiodwillbeassociated withagreaterincreaseinsexualdysfunctionasmeasuredbythesexualdomainsummary scorefromtheExpandedProstateCancerIndexComposite(EPIC). HypothesisSet3:Relationshipofsexualdy sfunction,sleepdisturbance,andfatigueto depressivesymptomatologyandcancer-relateddistress 3A.Greaterincreasesinfatigueoverthethree-monthperiodwillbeassociatedwith greaterincreasesincancer-relateddistress. 3B.Greaterincreasesinfatigueoverthethree-monthperiodwillbeassociatedwith greaterincreasesindepressivesymptomatology. 3C.Greaterincreasesinsexualproblemsoverthethree-monthperiodwillbeassociated withgreaterincreasesincancer-relateddistress. 3D.Greaterincreasesinsexualproblemsoverthethree-monthperiodwillbeassociated withgreaterincreasesindepressivesymptomatology. 3E.Greaterincreasesinsleepdisturbanceoverthethree-monthperiodwillbeassociated withgreaterincreasesincancer-relateddistress. 3F.Greaterincreasesinsleepdisturbanceoverthethree-monthperiodwillbeassociated withgreaterincreasesindepressivesymptomatology. Basedontheoutcomeofthefirstsetsofhypotheses,weexploredwhethersexual dysfunction,sleepdisturbance,and/orfatiguemediatedtheexpectedrelationshipbetween hotflashesandcancer-relateddistressanddepressivesymptomatology.

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21 Hypothes isSet4:Moderatingeffectsofmascu lineself-imageintherelationshipbetween hotflashesanddepressivesymptomato logyandcancer-relateddistress 4A.Masculineself-image(pre-treatment)asmeasuredbytheBemSexRoleInventory ShortForm(BSRISF)willmoderatetherelationshipbetweenhotflashexperienceand cancer-relateddistress. 4B.Masculineself-image(pre-treatment)willmoderatetherelationshipbetweenhot flashexperienceanddepressivesymptomatology. Foreachofthesehypothesesitwasanticipatedthatthecombinationofhigherlevelsof masculineself-imageandaworseexperienceofhotflasheswouldbeassociatedwith higherlevelsofcancer-relateddistressanddepression. HypothesisSet5:Moderatingeffectsofcatastrophizingintherelationshipbetweenhot flashesanddepressivesymptomatologyandcancer-relateddistress 5A.Catastrophizingpotential (pre-treatment)asmeasuredbytheHotFlash CatastrophizingScale(HFCS)willmoderatetherelationshipbetweenhotflash experienceandcancer-relateddistress. 5B.Catastrophizingpotential (pre-treatment)willmoderatetherelationshipbetweenhot flashexperienceanddepressivesymptomatology. Foreachofthesehypothesesitwasanticipatedthatthecombinationofhigherlevelsof catastrophizingandworsehotflasheswouldbeassociatedwithhigherlevelsofcancerrelateddistressanddepression.

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22 Me thod Participants ParticipantswerementreatedattheH.LeeMoffittCancerCenter(HLMCC) andJamesA.HaleyVeteransHospital(JAHVAH).Tobeeligibleforparticipation, thesepatientsmust1)havebeendiagnosedwithprostatecancer;2)havebeenscheduled toreceivehormonaltherapy(partialorcompleteandrogenblockade)foraperiodofthree months;3)havenoclinicalevidenceofmetastaticdiseaseorhaveasymptomaticnewly diagnosedmetastaticdisease;4)havenopriorexperiencewithhormonaltherapy;6)be greaterthan18yearsofage;7)beabletospeakandreadEnglish;8)haveatleastasixth gradeeducation;and9)beabletogiveinformedconsent. Procedure Eligiblepatientswereidentifiedwiththeassistanceofoncologiststreatingthese patientsandcomputerizedmedicalrecords.Patientswereapproachedduringaclinicvisit priortotheinitiationofhormonaltreatment.Menwhoagreedtoparticipatewereaskedto signaninformedconsentform(seeAppendixA)andweregivenapacketof questionnairesassessingdemographiccharacteristics,fatigue,hotflashes,depressive symptomatology,andotherpsychosocialvariables.Thesequestionnaireswerecompleted withinoneweekofthepatientsfirsthormonaltreatmentandservedasabaseline measureforthevariablesofinterest.Approximatelysixweeksafterthisinitial assessment,participantsweretelephonedathome.Atthispoint,theywereaskedtoreport onthefrequencyandseverityofhotflasheswithintheprevioustwoweeks,aswellasthe

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23 d egreetowhichthehotflasheshadinterferedwithseverallifedomains.Participants wereaskedtocompleteanotherpacketofquestionnairesapproximatelythreemonths aftertheinitialbaselinevisit.Forparticipantswithascheduledappointmentatthistime, theseassessmentswerecompletedinclinic.Forthosewhowerenotscheduledtocometo HLMCCorJAHVAH,thiswascompletedeitherbymailortelephone. Measures Demographicdata .Demographicinformationwasobtainedthroughaself-report questionnaire.Variablesassessedincludeage,height,weight,race/ethnicity,marital status,employmentstatus,annualhouseholdincome,andeducationallevel.This informationwascollectedatthebaselineassessment(seeAppendixE). Diseaseandtreatmentvariables .TheHLMCCcomputerizedpatientdatabase andmedicalchartswerereviewedtoobtaininformationondateofcancerdiagnosis, diseasestage,recentPSAvalues,andotherrelevantdiseaseandtreatmentcharacteristics. Participantswerealsoaskedtoprovideaself-ratingoftheirperformancestatus (Wingard,Curbow,Baker,&Piantadosi,1991;seeAppendixE). Hotflashes. Hotflashfrequencyandseveritywereassessedusingmethods similartothoseusedbyCarpenterandcolleagues(1998)intheirevaluationofhotflashes inpostmenopausalwomentreatedforbreastcancer.Specifically,participantswereasked iftheyhadexperiencedhotflashesintheprevioustwoweeks.Iftheparticipant respondedaffirmatively,hewasbeaskedtoestimatethenumberofhotflashes experiencedoverthepasttwoweeksandtoratetheirseverityusingafour-pointscale(1 =mild;4=verysevere).Thisinformationwascollectedatthefirstassessmentandatthe six-weekandthree-monthfollow-upassessments.Asinpriorresearch(Sloanet.al.,

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24 2001) ,atotalhotflashscorewascalculatedbymultiplyinghotflashfrequencybyhot flashseverity.Thismethodispreferredbecauseittakesintoaccountbothfrequencyand severity,providinganoutcomemeasurethatissensitivetochangesineithervariable(see AppendixF).Datacollectedatthefirstassessmentwereusedtoconfirmthatmenwere notexperiencinghotflashespriortoinitiationofhormonaltherapy.Menreportinghot flashesatthebaselineassessmentwereeliminatedfromanalysesinordertoprovidea homogenoussampleintermsofexperiencewiththevariableofinterest. Hotflashinterference. TheHotFlashRelatedDailyInterferenceScale(HFRDIS; Carpenter,2001;seeAppendixG)isaten-itemscalethatassessesthelevelatwhichhot flashesinterferewithavarietyofdailyactivitiesandoverallqualityoflife.Interference isratedonan11-pointscale(0=donotinterfere;10=completelyinterfere).Reliability, convergentvalidity,constructvalidity,andsensitivitytochangeovertimehavebeen showninbothbreastcancersurvivorsandhealthycomparisonwomen(Carpenter,2001). Thismeasurewasincludedatallthreedatacollectionpoints(baseline,six-weekfollowup,three-monthfollow-up).Inthepresentstudy,hotflash-relatedinterferencewas evaluatedasapredictorofchangesinsleep,mood,andsexuality.Itemsassessingthe degreetowhichhotflashesinterferewitheachofthesethreeconstructsarealsoincluded inthestandardversionoftheHFRDIS.Toeliminatethepotentialconfoundinginfluence ofthisconstructoverlap,thesethreeitemswereeliminatedfromtheversionofthe HFRDISusedinthepresentstudy.Theinternalconsistencyreliabilityestimateforthe seven-itemversionofthismeasurewascomparabletothatoftheoriginal10-item measure(alpha=.98).

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25 F atigue. TheFatigueSymptomInventory(FSI;Hannetal,1998;seeAppendix H)isa14-temscalethatassessesthefrequency,severity,anddisruptivenessoffatigue. Frequencyismeasuredintwoways:thenumberofdaysfatiguewasexperiencedinthe pastweekandtheportionofthedayonaveragetherespondentsfeltfatigued.Most,least, andaveragefatigueseverityinthepastweekaremeasuredon11-pointscales(0=notat allfatigued;10=asfatiguedasIcouldbe).Disruptivenesswithqualityoflifeinseven differentdomainsisalsoevaluated.Thesedomainsareassessedonseparate11-point scales(0=nointerference;10=extremeinterference).Responsestothesesevenitems aresummedtoprovideatotalinterferencescore.Previousresearchhasdemonstratedthe reliabilityandvalidityoftheFSIwithindividualsdiagnosedwithcancer(Hannetal., 1998;Jacobsenet.al.,1999).Forthepurposesofthecurrentstudy,thehighestlevelof fatigueinthepastweekwasusedastheoutcomeofinterest.Fatiguewasassessedat baselineandthree-monthfollow-upassessments. Sleepquality. ThePittsburghSleepQualityIndex(PSQI;Bussyeet.al.,1988;see AppendixI)isa19-itemscaledesignedtoassesssleeppatterns,quality,anddisturbances inthepastmonth.Forthepurposesofthecurrentstudy,asubsetofsevenitemswasused andthetimeframeofinterestwasreducedtothepastweekinordertobeconsistentwith theothermeasuresgiven.Themeasurecanbeusedtodescribesevencomponents: subjectivesleepquality,sleeplatency,sleepduration,habitualsleepefficiency,sleep disturbances,useofsleepmedication,anddaytimedysfunction.ThePSQIhasshown acceptablereliabilityandvaliditywhenadministeredtobothhealthyandchronicallyill individuals.Ithasalsobeenusedinstudiesevaluatingtheimpactofhotflashesinwomen withbreastcancer(Steinet.al.,2000;Weitzneret.al.,2002).Forthecurrentstudy,the

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26 p rimaryoutcomeofinterestwastheitemthatassessedsleepquality.Thiswasassessed usingafour-pointscale(0=verygood;3=verybad).Habitualsleepefficiencywasalso calculatedandusedasanadditionaloutcomemeasureinexploratoryanalyses.These indicesofsleepwereassessedatthebaselineandthree-monthfollow-upassessments. Depressivesymptomatology.TheCenterforEpidemiologicalStudies DepressionScale(CES-D;Radloff,1977;seeAppendixJ)isa20-itemmeasureof depressivesymptomatology.Respondentsratehowfrequentlytheyhaveexperienced eachdepressivesymptominthepastweekona4-pointscale(0=rarelyornoneofthe time;3=mostorallofthetime).Itemsaresummedtoproducescoresrangingfromzero to60.TheCES-Dhasgoodinternalconsistencywithalphasof.85forthegeneral populationand.90forapsychiatricpopulation(Radloff,1977). ThevalidityoftheCESDh asbeendemonstratedwithawiderangeofpopulations,includingcancerpatients (Beeber,Shea,&McCorkle,1998;Hann,Winter,&Jacobsen,1999).Depressive symptomatologywasassessedatthebaseline(alpha=.86)andthree-monthfollow-up (alpha=.91)assessmentswithgoodreliabilityestimatesateachtimepoint. Cancer-relateddistress. TheImpactofEventsScale(IES;Horowitz,Wilner, Alvarez,1979;seeAppendixK)consistsof18itemsdesignedtomeasuresubjective distressrelatedtoaparticularevent.Forthepurposesofthecurrentinvestigation, participantswereaskedtorespondtoeachiteminregardstotheircancerandits treatment.Itemcontentreflectsbothintrusivethoughtsandavoidantresponses.These subscalescanbeevaluatedindependentlyoratotaldistressscorecanbecalculatedby summingall18responses.Totaldistressscorewasusedinthecurrentinvestigation. Respondentswereaskedtoindicatehowfrequentlyeachcommentwastrueforthem

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27 d uringthepastweekusingafour-pointscale(0=notatall;1=rarely;3=sometimes;5= often).PreviousresearchhassupportedtheuseoftheIESasameasureofcancer-related distressinasampleofbreastcancerpatients(Thewes,Meiser,&Hickie,2001).Both internalconsistency(alpha=.91fortotalscale)andtest-retestreliability(r=.80fortotal scale)wereacceptableintheirsample.Cance r-relateddistresswasassessedatthe baseline(alpha=.87)andthree-monthfollow-up(alpha=.92)assessmentswithgood internalconsistencyestimatesateachtimepoint. Masculineself-image. TheBemSex-RoleInventoryShortForm(BSRISF; Bem,1981;seeAppendixL)isa30-itemadaptationofBem'soriginalinventory designedtoinvestigatemasculinityandfemininityasindependentdimensionsofsexrole identity.Respondentsareaskedtoratethemselvesastohowwellstereotypically masculine(e.g.defendmyownbeliefs,independent,assertive)andfeminineadjectives (e.g.affectionate,understanding,warm)describethem.Rankingsaremadeonasevenpointscale(1=nevertoalmostnevertrue;7=alwaysoralmostalwaystrue).Internal consistencyreliabilityfortheentirescaleisgenerallyconsideredacceptablewith estimatesrangingfromalpha=.75toalpha=.87.Arecentstudyconfirmedthevalidity oftheBSRI(Holt,1998),suggestingthatdespiterecentshiftsingenderroles,this instrumentremainsavalidmeasureofsexrolestereotypes.Genderrolewasmeasuredat boththebaselineandthree-monthfollow-upassessments.Totalmasculineself-image wastheoutcomeofinterest.Estimatesofinternalconsistencyreliabilitywerestrongat boththebaseline( =.84)andthree-monthfollow-up( =.89)assessments. Catastrophizing. TheHotFlashCatastrophizingScale(HFCS;seeAppendixM) wasdevelopedforuseinthecurrentstudybymodifyingtheinstructionsanditemcontent

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28 o ftheFatigueCatastrophizingScale(FCS;Jacobsenet.al.,1999).Thescaleconsistsof tenitemsthataredesignedtoassesstendenciestoengageinnegativeself-statementsand overlynegativethoughtsaboutthefuture(i.e.IwouldtellmyselfthatIdidntthinkI couldbearthehotflashesanylonger.).Atthebaselineassessment,participantswere askedtoindicateonafive-pointscale(1=nevertrue;5=allofthetimetrue)howoften theythoughteachitemwouldbetrueforthemiftheyweretoexperiencehotflashes.The instructionsforthebaselineassessmentwerewordedsuchthatparticipantswereaskedto respondtoeachitembyimagininghowtheymightreactiftheyweretoexperiencehot flashes.Sincethemajorityofparticipantshadnotexperiencedahotflashatthefirst assessment,theywereprovidedwithacommonlyciteddefinitiontouseasaguide (Kronenberg,1994).Internalconsistencyforthismeasureinthecurrentstudywasgood (alpha=.93).Atthethree-monthfollow-upassessment,participantswereaskedto respondtoaslightlydifferentversionofthescalethataskedthemtoindicatehowthey werecurrentlyrespondingtohotflashes(seeAppendixN).Participantswhowerenot experiencinghotflashesdidnotcompletethismeasure.Internalconsistencyreliability forthisversionwasalsogood(alpha=.93).Althoughcatastrophizingabouthotflashes hasnotbeeninvestigated,catastrophizingaboutfatiguehasbeenpositivelyassociated withfatigueseverityandnegativelyassociatedwithqualityoflifeinbreastcancer patients(Broeckelet.al.,1998;Jacobsenet.al.,1999)andcatastrophizingaboutcancer painhasbeenfoundtobepositivelyassociatedwithpainintensityincancerpatients (Jacobsen&Butler,1996;Lin,1998;Wilkie&Keefe,1991).Atotalscorewasderived bytakingthemeanofthe10ratings.

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29 Quality oflife .TheExpandedProstateCancerIndexComposite(EPIC;Wei, Dunn,Litwin,Sandler,&Sanda,2000;seeAppendixO)isa22-itemmeasuredesigned tomeasurequalityoflifeissuesinmenwithprostatecancer.Itwasadaptedfromthe UniversityofCaliforniaLosAngelesProstateCancerIndex(UCLA-PCI;Litwinet.al., 1998)andwasexpandedtoincludespecificitemsassessingirritativeandobstructive voidingsymptoms,hematuria,additionalbowelsymptoms,andhormonalsymptoms.The EPICyieldsfourdomain-specificsummaryscores:urinary,bowel,sexual,andhormonal. ItemsareratedusingaLikertscaleformat,withtherangeofresponseoptionsdependent upontheitem.Multi-itemscalescorescanbetransformedlinearlytoa0to100scale, withhigherscoresreflectingbetterhealth-relatedqualityoflife(HRQOL).Eachofthe fourdomainsummaryscoresexhibitgoodinternalconsistency(allalphas>.82)andtestretestreliability(allr>.80)overatwo-weektothree-monthperiod.Forthepurposesof thecurrentstudy,thesexualdomainsummaryscorewillbeusedastheoutcomeof interest.Qualityoflifewasmeasuredatthebaseline(alpha=.93)andthree-month follow-up(alpha=.87)assessmentswithgoodreliabilityestimatesateachpoint.

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30 Re sults Participantcharacteristics Atotalof103menwereinvitedtoparticipateinthecurrentstudy.Ofthose,four (4%)declinedparticipation,five(5%)weredeterminedtobeineligible,andten(10%) weredroppedfromthestudybecausetheydidnotreturntheirbaselinequestionnaires withintheallowabletimeframe.Oftheremaining84men,fourwithdrewbetweenthe baselineandthree-monthfollow-upassessments.Datafromtheremaining80men(78% ofthoseapproached)wereretainedtoevaluatetheproposedhypotheses.Forpurposeof comparison,the23menwhodidnotcompletethestudyweregroupedtogetherasnonparticipants.Participantsandnon-participantswerecomparedondemographicand clinicalvariablestoseeifthetwogroupsdifferedinasystematicfashion.Nosignificant (p<.05)differenceswerefoundwithregardtoanyofthedemographicorclinical characteristicsassessed.Significancetestsforallvariablescomparedcanbefoundin Table1. The80menwhocomprisedthefinalsamplerangedfrom48to90yearsofage(M= 72.74,SD=9.89).TheywerepredominantlyCaucasian(88%)andcurrentlymarried (78%).Themajorityhadatleastapartialcollegeeducationorspecializedtraining(71%), wereretired(73%),andreportedanannualhouseholdincomeofunder$40,000(73%). SeeTable2forcompletedemographicinformationforthissample.

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31 T able1 Comparisonofdemographicandclinicalvariablesbetweenstudyparticipantsandnonparticipants. Participants (N=80) Non-participants (N=23) Variable n n statisticpvalue Age 72.74 (9.89) 72.65 (10.58) t=-0.04.971 Ethnicity 2=1.67 .196 Hispanic 9 5 NotHispanic 71 18 Race 2=1.44 .487 White/Caucasian 70 22 Black/AfricanAmerican 7 1 Other 3 0 RecruitmentSite 2=0.31 .578 MCC 23 8 JAHVAH 57 15 TimeSinceDiagnosis (years) 2.99 (4.45) 2.32 (3.65) t=-0.65.515 BaselinePSA(ng/ml)22.80 (111.80) 22.18 (33.53) t=-0.04.965 LHRHAgonistUsed 2=0.12 .734 Leuprolide 19 6 Goserelin 61 16 TreatmentCategory 2=0.12 .944 Primarytreatment22 7 Adjuvanttreatment31 9 Biochemicalfailure27 7

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32 T able2 Demographiccharacteristicsofthestudysample Variable N=80 Age(Mean,SD) 72.74(9.89) Ethnicity Hispanic NotHispanic 9(11.3%) 71(88.8%) Race White/Caucasian Black/AfricanAmerican Other 70(87.5%) 7(8.8%) 3(3.7%) MaritalStatus Single,nevermarried Married Divorced Widowed 2(2.5%) 62(77.5%) 6(7.5%) 10(12.5%) Education 7thgradeorless J uniorHighSchool(7th,8th,&9thgrade) P artialHighSchool(10thor11th) HighSchoolGraduate PartialCollegeorSpecializedTraining CollegeorUniversityGraduate Graduateorprofessionaltraining 1(1.3%) 4(5.0%) 10(12.5%) 12(15.0%) 30(37.5%) 14(17.5%) 9(11.3%) Employmentstatus Full-timeatjob Part-timeatjob Disabled Seekingwork Retired 11(13.8%) 5(6.3%) 4(5.0%) 2(2.5%) 58(72.5%) Totalhouseholdincome Lessthan$10,000 $10,000-$19,999 $20,000-$39,999 $40,000-$59,999 $60,000-$100,000 Greaterthan$100,000 Didnotreport 10(12.8%) 22(28.2%) 26(33.3%) 13(16.7%) 6(7.7%) 1(1.3%) 2(2.5%)

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33 T imesinceprostatecancerdiagnosisrangedfromdayofenrollmentinthestudy to18.33years(M=2.99,SD=4.45).Twenty-sevenofthemenwereclassifiedas biochemicalfailures(38%)meaningthatlabresultsindicatedasteadilyrisingPSA despitepriortreatment.Oftheremainingparticipants,22ofthemenreceivedanLHRHagonistastheirprimaryformoftreatment(24%),andtheremaining31men(39%)were receivingthisformoftreatmentinadditiontoorinpreparationforanotherformof treatment(e.g.,prostatectomyorexternal-beamradiation).AveragePSAvaluesatthe timeofrecruitmentrangedfrom0.6ng/mLtoover1000ng/mL(M=22.80,SD=111.80). Three-monthfollow-upPSAvalueswereavailablefor67ofthe80men(84%).Atthis timepoint,averagePSAvaluesrangedfrombelow0.1ng/mL(undetectable)to97.40 ng/mL(M=2.34,SD=11.88).Twelve(15%)ofthemenwereprescribedanantiandrogen agent(bicalutamide)priortoinitiationofLHRH-agonists.Atthethree-monthfollow-up assessment,onlytwooftheparticipantsreportedthattheyhadsoughtmedicationor herbalremediestoalleviatehotflashes.SeeTable3forcompleteclinicalandtreatment characteristicsforthissample.

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34Table3 Clinicalcharacteristicsofthestudysample Variable N=80 Yearssincediagnosis(Mean,SD) 2.99(4.45) LHRHagonist Leuprolide(Lupron/Eligard) Goserelin(Zoladex) 19(23.8%) 61(76.3%) Gleasonscoreatdiagnosis 2 5 6 7 8 9 10 Unknown 1(1.5%) 4(5.9%) 26(38.2%) 24(35.3%) 11(16.2%) 1(1.5%) 1(1.5%) 12(15.0%) Priortreatment Prostatectomyonly Brachytherapyonly Externalbeamradiotherapyonly Combination None 7(8.8%) 3(3.8%) 8(10.0%) 9(11.3%) 53(66.3%) Concurrenttreatment Externalbeamradiotherapy Otherdrugs(i.e.Zometa) None 18(22.5%) 3(3.8%) 59(73.8%) ProstateSpecificAntigen(PSA(ng/ml) Baseline(Mean,SD) 3-MonthFollow-Up(Mean,SD) 22.8(111.80) 2.34(11.88) Karnofsky(performancestatusrating) 1:Abletocarryonnormalactivityordoworkwithno physicalcomplaintsorproblems. 2:Abletocarryonnormalactivityordoworkevenwith minorphysicalcomplaints. 3:Abletocarryonnormalactivityordoworkwitheffort becauseofphysicalproblems. 4:Unabletocarryonnormalactivitybutcaresforself. 5:Unabletocarryonnormalactivityandrequiresoccasional helpfromothers,butisabletocareformostoftheir personalneeds. 17(21.3%) 28(35.0%) 20(25.0%) 5(6.3%) 8(10%) Karnofsky(performancestatusrating) 6:Requiresconsiderablehelpfromothersandrequires frequentmedicalcare. 7:Disabledandrequiresspecialcareandhelp. 2(2.5%) 0(0.0%)

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35 P articipantsexperienceofhotflashes Atthebaselineassessment,eightoftheparticipantsreportedexperiencinghot flashesintheprevioustwoweeks.Thesemenhadexperiencedonetofourhotflashes (M=2.13,SD=0.99),withanaverageseverityratingof2.13(SD=0.64)onafour-point scale(1=mild;4=verysevere).Inordertomaintainahomogenoussampleintermsof initialexperiencewithhotflashes,theseeightmenweredroppedfromtheremainderof theanalyses.Oftheremaining72men,twocouldnotbereachedtocompletethesixweekfollow-upassessment,butwereabletocompletethethree-monthassessment.Of the70menwhocompletedthemidpointassessment,38reportedexperiencinghotflashes six-weeksafterinitiationofhormonedeprivationtherapy(54%).Thesemenreportedan averageseverityratingof1.76(SD=0.82),whichmostcloselycorrespondstoamoderate level.Thenumberofhotflashesreportedatthistimeperiodrangedfromoneto154 (M=42.05,SD=46.11)intheprevioustwoweeks.Bythethree-monthfollow-up,50men (69%)werereportinghotflashes.Theaverageseverityratinghadrisento1.96 (SD=0.76),withthenumberofhotflashesreportedrangingfromtwoto266(M=47.26, SD=51.37)intheprevioustwoweeks.Inordertoevaluatechangeinhotflashvariables acrosstime,pairedt-testswereperformed.Significantincreasesinhotflashfrequency werenotedbetweenthebaselineandthemidpointfollow-up, t (70)=4.80, p <.0001, betweenthemidpointandthree-monthfollow-up, t (70)=2.50, p <.02,andbetweenthe baselineandthree-monthfollow-up, t (72)=5.80, p <.0001.Perceivedseverityofhot flashesalsoincreasedbetweenthebaselineassessmentandthemidpointfollow-up, t (70)=7.49, p <.0001,betweenthemidpointandthree-monthfollow-ups, t (70)=4.53, p <.0001,andbetweenthebaselineandthree-monthfollow-up, t (72)=10.46, p <.0001.

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36 P reliminaryanalyses Post-hocpoweranalyseswereconductedforbothunivariateandmultivariate analysesbaseduponthesamplesizeof72.Withregardtounivariateprocedures,power todetectamediumeffectforcorrelationalanalyseswas.75(p<.05,two-tailed;r=.30; Cohen,1988).Previousresearchsuggeststhateffectsofthismagnitudearecommonwith regardtorelationshipbetweenadversesymptomstates(e.g.pain,fatigue)and psychologicaldistress.Thesamesamplesizewasappliedtopoweranalysisformultiple regressionanalyseswiththefollowingassumptions:1)baselineandfollow-upmeasures ofpsychologicaldistresswouldbecorrelatedatr=.55orr2=.30;and2)theadditionof h otflasheswouldaccountforanadditional6%ofvariability(smalltomediumeffect; Cohen,1988)intheoutcomeofinterest(depressionordistress)aboveandbeyondthe varianceaccountedforbybaselinevalues.Powertodetectanincrementofthis magnitudeis.70with72cases. Priortoanalyzingtheproposedhypotheses,Spearmanrank-ordercorrelations werecomputedinordertoidentifypotentiallyconfoundingrelationshipsofdemographic andclinicalvariableswithpredictorvariables,outcomevariables,andproposed mediatorsormoderators(seeTable4).First,correlationsbetweenpredictorvariables (hotflashfrequency,hotflashseverity,hotflashscore,andhotflash-relatedinterference) anddemographicandclinicalvariableswereexamined.Twosignificantassociations werenoted.KarnofskyPerformanceStatus(ameasureoffunctionalimpairment)was negativelyassociatedwithhotflashfrequency,suchthatincreasedfrequencyofhot flasheswasassociatedwithalesserdegreeofimpairment( r (72) =-.25, p <.04). Additionally,theLHRH-agentadministeredwasnegativelyassociatedwithhotflash-

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37 T able4 CorrelationsbetweenDemographicandClinicalVariablesandPredictorVariables HFSeverityHF Frequency Variable rprp DemographicVariables Age(years) -.08.50-.14.23 Ethnicity(Hispanicvs.Non-Hispanic) .10.38.03.83 Race(Hispanicvs.Non-Hispanic) .20.09.21.08 MaritalStatus(marriedvs.unmarried) .04.69.02.88 Education(HSorlessvs.BeyondHS) -.03.79-.004.97 Employment(workingvs.notworking) .12.32.13.26 AnnualIncome(under$40,000vs.over$40,000).03.79.07.58 ClinicalVariables Timesincediagnosis -.05.67.04.75 LHRHagonist(leuprolidevs.goserelin) -.16.17-.16.19 Gleasonscoreatdiagnosis .09.49.02.90 KarnofskyPerformanceStatusatbaseline-.17.16-.25.04* BaselinePSA .07.58.08.48 Follow-upPSA -.14.30-.06.65 HF Score HF-Related Interference Variable rprp DemographicVariables Age(years) -.13.29-.08.48 Ethnicity(Hispanicvs.Non-Hispanic) .05.67.08.51 Race(Hispanicvs.Non-Hispanic) .15.22.09.47 MaritalStatus(marriedvs.unmarried) .02.86-.06.60 Education(HSorlessvs.BeyondHS) -.004.98.06.60 Employment(workingvs.notworking) .13.27-.12.30 AnnualIncome(under$40,000vs.over$40,000).07.55.02.88 C linicalVariables Timesincediagnosis .02.85-.13.27 LHRHagonist(leuprolidevs.goserelin)-.17.14-.23.05* Gleasonscoreatdiagnosis .03.83.01.93 KarnofskyPerformanceStatusatbaseline-.22.06.003.99 BaselinePSA .09.43-.08.50 Follow-upPSA -.07.59-.07.57

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38 r elatedinterference,suchthatreceiptofleuprolidewasassociatedwithgreater interferenceduetohotflashes( r (72)=-.23, p <05). Next,relationshipsamongtheoutcomevariables(depressivesymptomatology andcancer-relateddistress)anddemographicandclinicalvariableswereexamined. Participantsendorsingagreaternumberofdepressivesymptomswerelesslikelytobe working( r (72)=-.26, p <.03),andreportedagreaterdegreeofimpairmentindaily functioning( r (72)=.24, p <.04).Relationshipswithremainingdemographicandclinical variableswerenotsignificant(Table5). Table5 CorrelationsbetweenDemographicandClinicalVariablesandOutcomeVariables Depressive Symptomatology Cancerrelated Distress Variable rprp DemographicVariables Age(years) .004.97-.21.08 Ethnicity(Hispanicvs.Non-Hispanic)-.15.22.02.88 Race(Caucasianvs.Non-Caucasian) -.15.20-.01.91 MaritalStatus(unmarriedvs.married)-.13.29-.06.64 Education(HSorlessvs.BeyondHS)-.03.80.12.32 Employment(notworkingvs.working)-.26.03*.01.94 AnnualIncome(<$40,000vs.>$40,000)-.18.14.05.65 ClinicalVariables Timesincediagnosis -.09.80.14.24 LHRHagonist(leuprolidevs.goserelin).18.12-.08.52 Gleasonscoreatdiagnosis .14.29.06.63 KarnofskyPerformanceStatusatbaseline.29.01*-.09.44 BaselinePSA -.17.17-.14.24 Follow-upPSA -.03.80-.11.42

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39 F inally,correlationsbetweentheproposedmediators(mostfatigue,sleepquality, sexualfunctioning)andmoderators(masculinegenderroleandcatastrophizingpotential) anddemographicandclinicalvariableswereexamined.Ofthepotentialmediating variables,higherlevelsofmostfatiguewasassociatedwithunmarriedstatus( r (70)=.23, p <.05)andpoorersleepqualitywasassociatedwithagreaterdegreeofimpairment indailyfunctioning( r (72)=.24, p <.04).Remainingcorrelationsbetweendemographic andclinicalcharacteristicsandproposedmediatingvariablescanbefoundinTable6. Table6 CorrelationsbetweenDemographicandClinicalVariablesandPotentialMediating Variables Most Fatigue Sleep Problems Sexual Functioning Variable rprprp DemographicVariables Age(years) .04.77.03.79-.09.48 Ethnicity(Hispanicvs.Non-Hispanic).14.26-.18.13.12.32 Race(Caucasianvs.Non-Caucasian)-.04.76-.09.46.03.79 MaritalStatus(unmarriedvs.married)-.23.05*-.03.77-.05.69 Education(HSorlessvs.BeyondHS).02.88-.09.44.14.26 Employment(notworkingvs.working)-.15.22-.02.87.07.56 AnnualIncome(<$40,000vs.>$40,000).13.29-.10.40.07.60 ClinicalVariables Timesincediagnosis -.14.22-.07.54-.13.28 LHRHagonist(leuprolidevs.goserelin).09.48.07.54-.09.48 Gleasonscoreatdiagnosis .14.29.13.32.06.64 KarnofskyPerformanceStatusatbaseline.19.11.24.04*.01.93 BaselinePSA -.15.23-.13.27.21.09 Follow-upPSA -.23.08-.13.33.22.10

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40 O fthepotentialrelationshipswithproposedmoderatingvariables,greaterlevels ofcatastrophizingpotentialwasassociatedwithalongertimesincediagnosis( r (71)= .35, p <.008),higherlevelsofmasculinegenderrolewereassociatedwithhavingan annualincomeofover$40,000( r (72)=.31, p <.008),longertimesincediagnosis( r (72)=.35, p <.003),alesserdegreeofimpairmentindailyfunctioning( r (72)=-.34, p < .004),andbeingprescribedleuprolideratherthangoserelin( r (72)=-.31, p <.003).A completelistingoftheseandotherrelationshipscanbefoundinTable7. Table7 CorrelationsbetweenDemographicandClinicalVariablesandPotentialModerating Variables M asculineGender Role Catastrophizing Potential Variable rprp DemographicVariables Age(years) -.02.86-.02.90 Ethnicity(Hispanicvs.Non-Hispanic)-.10.42.02.86 Race(Caucasianvs.Non-Caucasian).06.64-.08.51 MaritalStatus(unmarriedvs.married)-.18.13.12.33 Education(HSorlessvs.BeyondHS).17.16.23.06 Employment(notworkingvs.working).07.59.11.36 AnnualIncome(<$40,000vs.> $40,000) .31.008*.19.11 ClinicalVariables Timesincediagnosis .35.003*.31.008* LHRHagonist(leuprolidevs.goserelin)-.31.008*-.14.26 Gleasonscoreatdiagnosis -.21.11.05.74 KarnofskyPerformanceStatusatbaseline-.34.004*.03.80 BaselinePSA .01.92-.16.19 Follow-upPSA .07.62.04.76

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41 A variablewasconsideredtobeapotentialconfoundifitwassignificantlyassociated withthepredictorvariable,theoutcomevariable,andtheproposedmediatingor moderatingvariable.KarnofskyPerformanceStatus(KPS)metthesecriteriainthe evaluationofsleepdisturbanceasamediatoroftherelationshipbetweenhotflash frequencyanddepressivesymptomatology.Twosetsofregressionanalyseswere conductedbothwithandwithoutthispotentiallyconfoundingvariable.Neitheryielded significantresults(p>.10). Descriptivestatisticswereanalyzedinordertoevaluateoverallchangesin psychosocialmeasuresoverthethree-monthstudyperiod.Significantdeclinesin functioningwerenotedinseveralareas.ParticipantsscoresontheCES-Dsignificantly increasedfrombaseline( M =9.01, SD =7.59)tothethree-monthfollow-up( M =11.26, SD =10.11), t (72)=2.32, p <.05.Participantsalsoreportedagreaternumberofsleep problemsbetweenthebaseline( M =0.88, SD =0.79)andfollow-upassessments( M =1.09, SD =0.85), t (72)=2.13, p <.05.Declinesinsexualfunctioningwerealsoevidentbetween baseline(M=35.13,SD=27.03)andthree-monthfollow-up(M=18.43,SD=17.22), t (68)=-5.59, p <.001.AcompletelistingoftheseresultscanbefoundinTable8.

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42 T able8 DescriptiveandUnivariateStatisticsforPsychosocialVariables Variable RangeBaseline 3Month Follow-Up tp Depressive Symptomatology 0-489.01(7.59) 11.26(10.11) 2.32.02* Cancer-Related Distress 0-9011.57(11.39) 9.62(11.98) -1.38.17 SleepProblems0-30.88(0.79)1.09(0.85) 2.13.04* SleepEfficiency 0-10083.89(14.24)81.93(15.06)-1.00.32 MostFatigue0-104.82(3.30) 4.96(3.04) 0.43.67 Sexual Functioning 0-10035.13(27.03) 18.43(17.22) -5.59.0001* Catastrophizing 1-51.26(0.45) 1.36(06.0) 0.54.59 MasculineSelfImage 10-7050.79(10.42) 49.31(11.47) -1.30.20 Uni variatecorrelationswerealsocalculatedinordertodeterminetheassociationsamong studyvariablesatthebaselineandfollow-upassessments.Thesecorrelationscanbe foundinTable9.

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43 T able9 CorrelationMatrixofStudyVariablesatBaselineandThree-MonthFollow-Up 1234567 1HFfreqT3 1.0 2HFsevT3.71 *** 1.0 3HFscoreT3.93 *** .80 *** 1.0 4HFRDIST3.62 *** .65 *** .70 *** 1.0 5CatasT1 -.07.04-.09-.071.0 6CatasT3.55 *** .56 *** .63 *** .83 *** -.091.0 7BEMT1 .11.11.14.12.07-.071.0 8BEMT3 -.07.03-.01-.07.22-.18.61 *** 9CES-DT1-.03.03.02.26 .29 ** .42 ** -.23 10CES-DT3.17.10.20.44 *** .02.69 *** -.02 11IEST1.29 ** .13.21.26.37 ** .28-.09 12IEST3.26 .21.24 .30 ** .44 *** .33 -.06 13PSQIT1.13.05.14.26 .06.32 .03 14PSQIT3.35 ** .38 *** .41 *** .51 *** .02.50 *** .04 15FSIT1.15-.02.11.24 -.14.34 ** -.10 16FSIT2.17.15.22.42 *** -.08.46 *** -.02 17SexFxnT1 .10.04.05-.03-.06-.01.001 18SexFxnT3 -.02.003.0006-.01-.07-.01.14 *p<.05 **p<.01 ***p<.001

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44 T able9 (continued) 891011121314 8BEMT3 1.0 9CES-DT1 -.131.0 10CES-DT3 -.12.60 *** 1.0 11IEST1 -.03.39 *** .33 ** 1.0 12IEST3 .09.53 *** .46 *** .62 *** 1.0 13PSQIT1 -.02.46 *** .30 .15.33 ** 1.0 14PSQIT3 -.14.39 *** .45 *** .14.26 .60 *** 1.0 15FSIT1 -.13.37 ** .37 ** .19.18.42 *** .22 16FSIT2 -.09.25 .47 *** .07.22.34 ** .44 *** 17SexFxnT1 .18.01-.009-.02.04-.12-.02 18SexFxnT3 .10-.15-.07-.19-.18-.10-.03 T able9 (continued) 15161718 15FSIT1 1.0 16FSIT2 .45 *** 1.0 17SexFxnT1 -.15-.081.0 18SexFxnT3 .009-.13.45 *** 1.0 *p<.05 **p<.01 ***p<.001

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45 R elationshipbetweenhotflashesanddistress Thefirstsetofhypothesesproposedthataworseexperienceofhotflasheswould besignificantlyassociatedwithanincreaseinpsychologicaldistress.Beforeevaluating therelationshipbetweenhotflashesandchangesindistress,univariatecorrelations betweenhotflashesanddistressatthethree-monthfollow-upwereexamined.Ofthe fourhotflashindices(frequency,severity,score,andinterference),onlyhotflash-related interferencewassignificantlyassociatedwithdepressivesymptomatology, r (70)=.44, p <.0001.Hotflashfrequency, r (70)=.27, p <.03,hotflashscore, r (70)=.24, p <.04, andhotflash-relatedinterference, r (70)=.31, p <.009,wereallsignificantlycorrelated withcancer-relateddistressatthistimepoint.Acompletelistingofcorrelationsamong thesevariablescanbefoundinTable10. Table10 CorrelationsbetweenHotFlashVariablesandPsychologicalDistressVariablesat Three-MonthFollow-Up CES-DscoreIESscore Variable rprp HotFlashVariables HotFlashFrequency .17.16.27.03* HotFlashSeverity .10.40.21.07 HotFlashScore .20.10.24.04* HotFlash-RelatedInterference .44.0001*.31.009* An alyseswerethenconductedtotestthehypothesisthatmenreportingworse experienceswithhotflasheswouldexperiencegreaterincreasesinpsychologicaldistress overthethree-monthstudyperiod.Specifically,baselinelevelsofdistresswereentered

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46 o nthefirststepinhierarchicalregressionanalysesinordertocreatearesidualized changescore.Eachofthehotflashvariableswasthenenteredonthesecondstepinfour separateregressionequations.AsshowninTable11,depressivesymptomatology measuredpriortoinitiationofandrogen-deprivationtherapyaccountedfor36%ofthe varianceindepressivesymptomatologymeasuredatthethree-monthfollow-up( p < .0001).Hotflash-relatedinterferenceaccountedforanadditional8%oftheremaining varianceinthisvariable( p =.002).Althoughnoneoftheremaininghotflashvariables metthecriteriasetforsignificance( p <.05),hotflashfrequency( p=.0533)andhotflash score( p=.0530)bothapproachedsignificance,eachaccountingforanadditional3%of thevarianceindepressivesymptomatologywhenevaluatedindependently. Table11 RegressionAnalysesofHotFlashVariablesonDepressiveSymptomatologyatThreeMonthFollow-Up VariableR2changeCumulativeR2pvalue Equation#1 1.BaselineCES-DScore .52 .36.0001* 2.HotFlash-RelatedInterference.30.08.44.0020* Equation#2 1.BaselineCES-DScore .61 .36.0001* 2.HotFlashFrequency .19.03.39.0533 Equation#3 1.BaselineCES-DScore .60 .36.0001* 2.HotFlashSeverity .08.01.37.3958 Equation#4 BaselineCES-DScore .60 .36.0001* HotFlashScore .19.03.39.0530

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47 T obetterunderstandtherelativecontributionsofeachmeasureofhotflash experience,exploratoryregressionanalyseswereconducted,enteringallfourofthehot flashvariablessimultaneously.Hotflash-relatedinterferenceenteredthemodelfirst, accountingfor8%ofthevarianceinchangesindepressivesymptomatology( p =.002). Noneoftheremainingthreemeasureofhotflashexperienceaccountedforadditional varianceinchangesindepression( ps>.05). Identicalprocedureswerefollowedinordertodeterminetheabilityofhotflashes topredictchangesincancer-relateddistressoverthethree-monthstudyperiod.Asshown inTable12,baselinereportsofcancer-relateddistress accountedfor39%ofthevariance incancer-relateddistressmeasuredthreemonthslater( p <.0001).Noneofthefour measuresofhotflashexperienceaccountedforsignificantproportionsoftheremaining variance( ps>.10).

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48 T able12 RegressionAnalysesofHotFlashVariables onCancer-RelatedDistressatThree-Month Follow-Up VariableR2changeCumulativeR2pvalue Equation#1 1.BaselineIESScore .58 .39.0001* 2.HotFlash-RelatedInterference.15.02.41.1185 Equation#2 1.BaselineIESScore .59 .39.0001* 2.HotFlashFrequency .10.01.39.3358 Equation#3 1.BaselineIESScore .60 .39.0001* 2.HotFlashSeverity .14.02.40.1510 Equation#4 1.BaselineIESScore .60 .39.0001* 2.HotFlashScore .11.01.40.2366 R elationshipbetweenhotflashesandfatigue,sleepproblems,andsexualfunctioning Thesecondsetofhypothesesproposedthataworseexperienceofhotflashes wouldbeassociatedwithgreaterincreasesinfatigue,poorersleepquality,andgreater declinesinsexualfunctioningoverthethree-monthstudyperiod.Aswiththefirstsetof hypotheses,univariaterelationshipsbetweeneachofthevariablesatthefinalassessment pointwereexaminedpriortoconductinghierarchicalregressionanalyses(seeTable13).

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49 T able13 CorrelationsbetweenHotFlashVariablesandFatigue,SleepProblems,andSexual FunctioningatThree-MonthFollow-Up Most Fatigue Sleep Problems Sexual Functioning Variable rprprp HotFlashFrequency .17.15.35.003*-.02.86 HotFlashSeverity .15.22.39.0008*.003.98 HotFlashScore .22.06.41.0004*.0006.99 HotFlash-RelatedInterference.42.0004*.51.0001*-.01.94 Rat ingsofmostfatigueatthethree-monthfollow-upweresignificantlyassociated withhotflash-relatedinterference, r (70)=.42, p <.0001,butwerenotsignificantly associatedwithanyoftheremaininghotflashvariables.Inordertotestthehypothesis thatmenreportingworseexperienceswithhotflasheswouldalsoexperiencegreater increasesinfatigue,hierarchicalregressionanalyseswereconductedusingthesame proceduresasdescribedabove.AsshowninTable14,baselinelevelsofmostfatigue measuredpriortoinitiationofandrogen-deprivationtherapyaccountedfor21%ofthe varianceinratingsofmostfatiguethreemonthslater( p <.0001).Hotflash-related interferenceaccountedforanadditional10%ofthevarianceinratingsofmostfatigue( p <.003).Noneofthethreeremaininghotflashvariablesaccountedforasignificant portionoftheremainingvariance.

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50 T able14 SummaryofRegressionAnalysesofMostFatigueatThree-MonthFollow-Up VariableR2changeCumulativeR2pvalue Equation#1 1.BaselineMostFatigue .37 .21.0001* 2.HotFlash-RelatedInterference.32.10.32.0032* Equation#2 1.BaselineMostFatigue .44 .21.0001* 2.HotFlashFrequency .11.01.22.3365 Equation#3 1.BaselineMostFatigue .46 .21.0001* 2.HotFlashSeverity .16.03.23.1465 Equation#4 1.BaselineMostFatigue .43 .21.0001* 2.HotFlashScore .17.03.23.1139 P oorersleepqualitywasassociatedwithhotflashfrequency, r (72)=.35, p <.003, hotflashseverity, r (72)=.39,p<.0008,hotflashscore, r (72)=.41,p<.0004,andhot flash-relatedinterference r (72)=.51, p <.0001.Hierarchicalregressionanalyseswere thenconductedtoevaluatetheabilityofhotflashestopredictdecreasesinsleepquality. AsshowninTable15,baselinelevelsofsleepproblemsaccountedfor36%ofthe varianceinsleepqualitythreemonthsafterinitiationofandrogendeprivationtherapy( p <.0001).Eachofthefourmeasuresofhotflashexperienceaccountedforadditional varianceinratingsofsleepqualityatthethree-monthfollow-upassessmentwhen evaluatedindependently( ps<.0004).Hotflash-relatedinterferenceandhotflash severityaccountedforthelargestamounts,eachaccountingfor13%additionalvariance, followedbyhotflashscore(11%),andhotflashfrequency(8%).Forexploratory

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51 pur poses,theabilityofhotflashvariablestopredictchangesinhabitualsleepefficiency wasalsoevaluatedusingregressionanalyses.Noneofthefourindicesofhotflash experienceexplainedadditionalvarianceinsleepefficiencyatthethreemonth-followup aboveandbeyondbaselinelevelsofsleepefficiency( ps>.05). Table15 SummaryofRegressionAnalysesofSleepProblemsatThree-MonthFollow-Up VariableR2changeCumulativeR2pvalue Equation#1 1.BaselineSleepProblems.50 .36.0001* 2.HotFlash-RelatedInterference.38.13.49.0001* Equation#2 1.BaselineSleepProblems.56 .36.0001* 2.HotFlashFrequency .28.08.44.0035* Equation#3 1.BaselineSleepProblems.58 .36.0001* 2.HotFlashSeverity .36.13.49.0001* Equation#4 1.BaselineSleepProblems.55 .36.0001* 2.HotFlashScore .33.11.47.0004* S exualfunctioningwasnotsignificantlyassociatedwithanyofthefourindicesof hotflashexperienceincorrelationalanalyses( ps>.05).Baselinelevelsofsexual functioningaccountedfor20%ofthevarianceinsexualfunctioningthreemonthslater( p <.0001);however,noneofthehotflashvariablesaccountedforadditionalvariance(see Table16).

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52 T able16 SummaryofRegressionAnalysesofSexualFunctioningatThree-MonthFollow-Up VariableR2changeCumulativeR2pvalue Equation#1 1.BaselineSexualFunctioning.45 .20.0001* 2.HotFlash-RelatedInterference.006.000.20.9928 Equation#2 1.BaselineSexualFunctioning.45 .20.0001* 2.HotFlashFrequency -.03.001.20.8094 Equation#3 1.BaselineSexualFunctioning.45 .20.0001* 2.HotFlashSeverity .000.20.9911 Equation#4 1.BaselineSexualFunctioning.45 .20.0001* 2.HotFlashScore .005.000.20.9644 R elationshipbetweenFatigue,SleepProblems,SexualFunctioningandPsychological Distress Thethirdsetofhypothesesproposedthatmenexperiencinggreaterincreasesin fatigue,sleepproblems,andsexualimpairmentwouldreportgreaterincreasesin depressivesymptomatologyandcancer-relateddistress.Aswiththeprevioustwosetsof hypotheses,univariatecorrelationswillbepresentedfirst(Table17)followedbythe resultsofhierarchicalregressionanalyses.

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53 T able17 CorrelationsbetweenPsychologicalDistress VariablesandFatigue,SleepProblems, andSexualFunctioningatThree-MonthFollow-Up Depressive Symptomatology Cancer-related Distress Variable rp rp MostFatigue .47.0001*.22.07 SleepProblems .45.0001*.26.03* SexualFunctioning -.07.56 -.18.14 R atingsofdepressivesymptomatologyatthethree-monthfollow-upassessment weresignificantlycorrelatedwithratingsofmostfatigue, r (70)=.47, p <.0001,andsleep problemsatthesametimepoint, r (72)=.45, p <.0001.Sexualfunctioningwasnot associatedwithdepressivesymptomatology( p >.05). Inordertoevaluatethissetofhypotheses,baselinelevelsofdepressive symptomatologyandbaselinelevelsofthevariableofinterest(mostfatigue,sleep problems,sexualfunctioning)wereforcedintotheequationonthefirststep.Participants ratingofthevariableofinterestatthefollow-upassessmentwasthenenteredonthe secondstep,inordertodeterminetheuniquecontributionofchangeoccurringduringthe three-monthstudyperiod.Takentogether,ratingsofdepressivesymptomatologyand mostfatiguemadepriortoinitiationofandrogendeprivationtherapyaccountedfor39% ofthevarianceindepressivesymptomatologythreemonthslater( p <.0001).Ratingsof mostfatigueatthethree-monthfollow-upaccountedforanadditional9%ofthevariance indepressivesymptomatologyatthissamepoint( p <.0016). Inaseparateregressionequation,baselinedepressivesymptomatologyand baselinesleepqualityaccountedfor36%ofthevarianceindepressivesymptomatology

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54 t hreemonthslater( p <.0001).Theadditionofsleepqualitymeasuredatthethree-month follow-upaccountedforanadditional7%ofthevariance( p <.0064).Post-treatment ratingsofsexualfunctioningdidnotaccountforadditionalvarianceinpost-treatment levelsofdepressivesymptomatologywhenexaminedinthisfashion( p >.05).These resultsareshowninTable18. Table18 RegressionAnalysesofPotentialMediatorsonDepressiveSymptomatologyatThreeMonthFollow-UpR2changeCumulativeR2pvalue Equation#1 1.BaselineCES-DScore.50 .0001* BaselineMostFatigue.04 .39.0854 2.3-MonthMostFatigue.33.09 .48.0016* Equation#2 1.BaselineCES-DScore.54 .0001* BaselineSleepProblems-.14 .36.7776 2.3-MonthSleepProblems.33.07 .43.0064* Equation#3 1.BaselineCES-DScore.62 .0001* BaselineSexualFunctioning-.04 .37.8327 2.3-MonthSexualFunctioning.05.002 .37.6356 Similarprocedureswereusedinordertodeterminetherelativecontributionof changesinfatigue,sleepquality,andsexualfunctioningtochangesincancer-related distress.Initially,univariatecorrelationswereexamined.AsshowninTable17,cancerrelateddistresswassignificantlyassociatedwithsleepqualitythreemonthsafter initiationofandrogendeprivationtherapy,suchthathigherlevelsofcancer-related

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55 d istresswasassociatedwithpoorersleepquality, r (72)=.26, p <.03.Therelationship betweencancer-relateddistressandmostfatigueapproachedsignificance, r (70)=.22, p=.07.Sexualfunctioningwasnotasignificantcorrelateofcancer-relateddistress( p > .05). Takentogether,baselineratingsofcancer-relateddistressandmostfatigue accountedfor39%ofthevarianceincance r-relateddistressatthethree-monthfollow-up assessment( p <.0001).Levelsofmostfatigueatthethree-monthfollowupaccounted foranadditional3%ofthevarianceinbaselinelevelsofcancer-relateddistress;however, thisdidnotmeetthecriteriasetforsignificance( p =.07).Neithersleepproblemsnor sexualfunctioningaccountedforadditionalvarianceincance r-relateddistressafter accountingforbaselinelevels( ps >.05).TheseresultsappearinTable19. Table19 RegressionAnalysesofPotentialMediators onCancer-RelatedDistressatThree-Month Follow-UpR2changeCumulativeR2pvalue Equation#1 1.BaselineIESScore .62 .0001* BaselineMostFatigue -.03 .39.5613 2.3-MonthMostFatigue .19.03 .42.0731 Equation#2 1.BaselineIESScore .58 .0001* BaselineSleepproblems.21 .44.0098* 2.3-MonthSleepproblems.06.002 .45.6190 Equation#3 1.BaselineIESScore .59 .0001* BaselineSexualFunctioning.09 .37.6254 2.3-MonthSexualFunctioning-.10.008 .38.3891

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56 Tes tsofMediation Inordertotestformediation,threeconditionsmustbemet(BaronandKenney, 1986).First,thepredictorvariablemustbeassociatedashypothesizedwiththeoutcome variable(Figure1;Pathc).Itwashypothesizedthataworsehotflashexperiencewould beassociatedwithgreaterincreasesindepressivesymptomatologyandcancer-related distressoverthethree-monthperiod.Thepredictorvariableofinterest,hotflashes,was measuredinfourways(frequency,severity,score,andinterference).Ascanbeseenin Tables11,ofthefourindicesofhotflashexperience,onlyhotflash-relatedinterference wassignificantlyassociatedwithchangesindepressivesymptomatology.Noneofthe fourhotflashvariablesaccountedforsignificantvarianceinchangesincance r-related distress(seeTable12).Basedupontheseresultsandapplicationofthecriterion,hot flash-relatedinterferencewillserveasthesolepredictorvariableanddepressive symptomatologywillserveastheoutcomevariable. Thesecondconditionrequiresthatthepredictorvariableisassociatedas hypothesizedwiththemediator(Figure1;Patha).Threepotentialmediatorswere evaluated:changesinsleepproblems,mostfatigue,andsexualfunctioning.Itwas hypothesizedthatgreaterhotflash-relatedinterferencewouldbeassociatedwith decreasesinsleepqualityandsexualfunctioning,andincreasesinlevelsofmostfatigue overthethreemonthperiod.Regressionanalysesindicatethathotflash-related interferenceaccountedforsignificantvarianceinbothmostfatigue(Table14)andsleep quality(Table15)afteraccountingforbaselinelevelsofeachvariable.Hotflash-related interferencefailedtoaccountforsignificantvarianceinchangesinsexualfunctioning

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57 ( Table16).Consequently,onlymostfatigueandsleepqualitymetthiscriterionfor mediation. Thethirdconditionrequiresthatthemediatorisassociatedashypothesizedwith theoutcomevariable(Figure1;Pathb).Itwashypothesizedthatgreaterincreasesin mostfatigueandgreaterdecreasesinsleepqualityandsexualfunctioningwouldbe associatedwithgreaterincreasesindepressivesymptomatologyoverthethree-month period.AsshowninTable18,changesinbothsleepproblemsandmostfatigueemerged assignificantcontributorstochangesindepressivesymptomatology. Basedonthefindingsoutlinedabove,changesinmostfatigueandsleepquality wereevaluatedaspotentialmediatorsoftherelationshipbetweenhotflash-related interferenceanddepressivesymptomatology.Inordertobeconsideredamediator, inclusionofthesevariablesinregressionanalysesmustsignificantlyreduceoreliminate therelationshipbetweenthepredictorvariable(hotflash-relatedinterference)andthe outcomevariable(depressivesymptomatology). Mostfatigue Sleepproblems a b Hotflash-relatedinterference Depressivesymptomatology c Figure1. ModeloftheRelationshipbetweenHotFlash-RelatedInterferenceand DepressiveSymptomatologyasMediatedbyMostFatigueandSleepProblems AsshowninTable20,afteraccountingforchangesinmostfatigue,hotflashrelatedinterferencefailedtoaccountforasignificantproportionofthevariancein

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58 ch angeindepressivesymptomatology (p =.06).Atestoftheindirecteffectofhotflashrelatedinterferenceonchangesindepressionviachangesinmostfatiguewasassessed usingtheSobel(1982)testasdescribedbyBaronandKenny(1986).Resultsindicated thatthisreductionwasduetoasignificantmediationeffectoffatigueonhotflash-related interference( z =1.97, p <.05). Table20 EvaluationofChangesinMostFatigueandSleepProblemsasMediatorsofthe RelationshipbetweenHotFlash-RelatedInterferenceandChangesinDepressionR2changeCumulativeR2pvalue Equation#1 1.BaselineCES-DScore .47 .0001* BaselineMostFatigue .04 .7246 Three-MonthMostFatigue.26 .47.0147* 2.HotFlash-RelatedInterference.19.03 .50.0553 Equation#2 1.BaselineCES-DScore .51 .0001* BaselineSleepProblems-.12 .3104 Three-MonthSleepProblems.21 .43.1037 2.HotFlash-RelatedInterference.23.04 .46.0334* S imilaranalyseswererepeatedenteringchangesinsleepqualityasthepotential mediator.Hotflash-relatedinterferenceremainedasignificantpredictorofchangesin depressionaftercontrollingforchangesinsleepquality,accountingfor4%ofthe varianceinthisvariable( p =.03).Priortoincludingthisvariableintheregression equation,hotflash-relatedinterferenceaccountedfor8%ofthevarianceinchangesin depression.Therefore,theinclusionofsleepqualityrepresentsa50%reductionin varianceaccountedforbyhotflash-relatedinterference.Thefollow-upSobeltest

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59 co nfirmsthatsleepqualitydidnotcompletelymediatetherelationshipbetweenhotflashrelatedinterferenceanddepressivesymptomatology( z =1.49, p >.10). TestsofModeration Thefinaltwosetsofhypothesesproposedthatcatastrophizingpotentialand masculineself-imagewouldmoderatetherelationshipbetweenhotflashesand psychologicaldistress.Specifically,itwasproposedthatthecombinationofhigherlevels ofcatastrophizingandaworsehotflashexperiencewouldbeassociatedwithhigher levelsofcancer-relateddistressanddepression.Additionally,itwasanticipatedthatthe combinationofhigherlevelsofmasculineself-imageandaworsehotflashexperience wouldbeassociatedwithhigherlevelsofcancer-relateddistressanddepression. Inordertodetermineifeithermasculineself-imageorcatastrophizingpotential moderatedtherelationshipbetweenhotflashesanddepression,hierarchicalregression analyseswereconducted.Ineachequation,baselinelevelsofdepressionwereentered firstinordertocreatearesidualizedchangescore.Thiswasfollowedbyoneofthefour hotflashvariables,thenbyeithercatastrophizingpotentialormasculineself-image,and thenbytheappropriateinteractionterm.Eachofthepredictorvariablesandpotential moderatingvariableswerecenteredinordertoreducemulticollinearity(Aiken&West, 1991).Inthisstudy,eachofthehotflashvariables,catastrophizingpotential,and masculineself-imagewerecenteredbysubtractingthemeanoftherespectivevariable fromeachparticipantsscoreonthatvariable.AsshowninTables21and22,neither masculineself-imagenorcatastrophizingpotentialweresignificantmoderatorsofthe relationshipbetweenhotflashesanddepressivesymptomatology.

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60 T able21 EvaluationofMasculineSelf-Imageasa ModeratoroftheRelationshipbetweenHot FlashExperienceandDepressiveSymptomatologyR2changeCumulativeR2pvalue 1.BaselineDepression .65 .0001* HotFlashFrequency(A).15 .1203 MasculineSelf-Image(B).08 .40 .4114 2.AxB -.11.01.41 .2552 1.BaselineDepression .64 .0001* HotFlashSeverity(A).06 .5449 MasculineSelf-Image(B).09 .38 .3606 2.AxB -.16.03.40 .0948 1.BaselineDepression .65 .0001* HotFlashScore(A) .17 .0710 MasculineSelf-Image(B).07 .40 .5122 2.AxB -.14.02.42 .1565 1.BaselineDepression .54 .0001* HF-RelatedInterference(A).32 .0014* MasculineSelf-Image(B).03 .45 .7211 2.AxB -.17.03.48 .0650

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61 T able22 EvaluationofCatastrophizingPotentialasaModeratoroftheRelationshipbetweenHot FlashExperienceandDepressiveSymptomatologyR2changeCumulativeR2pvalue 1.BaselineDepression .65 .0001* HotFlashFrequency(A).15 .1711 CatastrophizingPotential(B)-.16 .41.1212 2.AxB -.04.001.42.7443 1.BaselineDepression .64 .0001* HotFlashSeverity(A).09 .3713 CatastrophizingPotential(B)-.17 .39.1071 2.AxB .02.0003.39.8535 1.BaselineDepression .64 .0001* HotFlashScore(A) .15 .1812 CatastrophizingPotential(B)-.15 .41.1418 2.AxB -.03.0007.41.7768 1.BaselineDepression .54 .0001* HF-RelatedInterference(A).30 .0215* CatastrophizingPotential(B)-.10 .45.3575 2.AxB .04.0009.46.7387 Co mparableregressionanalyseswerethenconductedtodetermineifeither masculineself-imageorcatastrophizingpotentialmoderatedtherelationshipbetweenhot flashesandcancer-relateddistress.AsshowninTable23,masculineself-imagedidnot moderatetherelationshipbetweenhotflashexperienceandcancer-relateddistress( ps> .05).

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62 T able23 EvaluationofMasculineSelf-Imageasa ModeratoroftheRelationshipbetweenHot FlashExperienceandCancer-RelatedDistressR2changeCumulativeR2pvalue 1.BLCancer-RelatedDistress.58 .0001* HotFlashFrequency(A).12 .2305 MasculineSelf-Image(B).01 .39.9460 2.AxB .11.01.41.2637 1.BLCancer-RelatedDistress.59 .0001 HotFlashSeverity(A)-.01 .1437 MasculineSelf-Image(B).14 .40.9082 2.AxB .04.002.40.6473 1.BLCancer-RelatedDistress.59 .0001 HotFlashScore(A) .12 .2331 MasculineSelf-Image(B).02 .40.8414 2.AxB .16.02.42.1014 1.BLCancer-RelatedDistress.58 .0001* HF-RelatedInterference(A).13 .1951 MasculineSelf-Image(B).03 .41.7570 2.AxB .14.02.43.1634 A differentpatternofresultsemergedwhenevaluatingcatastrophizingpotential asamoderator.Eachofthefourindicesofhotflashes(frequency,severity,score,and interference)wasevaluatedasanindependentpredictorofdistress.AsshowninTable 24,thereweresignificantmaineffectsforhotflash-relatedinterference( =.38, t =3.69, p <.0005)andcatastrophizingpotential( =.42, t =4.16, p <.0001).

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63 T able24 EvaluationofCatastrophizingPotentialasaModeratoroftheRelationshipbetweenHot FlashExperienceandCancer-RelatedDistressR2changeCumulative R2pval ue 1.BLCancer-RelatedDistress.47 .0001* HotFlashFrequency(A).27 .0175* CatastrophizingPotential(B).31 .46.0024* 2.AxB .21.03.49.0510 1.BLCancer-RelatedDistress.51 .0001* HotFlashSeverity(A) .12 .2201 CatastrophizingPotential(B).27 .46.0124* 2.AxB -.07.004.46.4948 1.BLCancer-RelatedDistress.47 .0001* HotFlashScore(A) .28 .0115* CatastrophizingPotential(B).32 .47.0018* 2.AxB .20.03.49.0621 1.BLCancer-RelatedDistress.40 .0001* HF-RelatedInterference(A).38 .0005* CatastrophizingPotential(B).42 .48.0001* 2.AxB .32.07.55.0024* I naddition,theinteractionbetweenhotflash-relatedinterferenceand catastrophizingwasalsosignificant( =.32, t =3.16, p <.0024).Inordertointerpret thissignificantinteraction,threesimplelinesoftheregressionofcancer-relateddistress (y)onhotflashinterference(x)asafunctionofthreevaluesofcatastrophizingpotential (seeFigure2).Thesethreevaluescorrespondtoonestandarddeviationabovethemean, themean,andonestandarddeviationbelowthemean.

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64 -5 0 5 10 15 20 25 Low Medium High HotFlash-RelatedInterferenceCancer-RelatedDis t High Medium Low F igure2 .EffectofHotFlash-RelatedInterferenceonCancer-RelatedDistressby CatastrophizingPotential Theslopeofthecancer-relateddistressscoreswassignificantlydifferentfrom zeroforhigh(slope=.63, t =2.68, p <.01)andmeanlevels(slope=.29, t =2.90, p < .01)ofcatastrophizingpotential,butnotforlowlevels(slope=-.05, t =0.47, p >.05). Theseresultssuggestthatcatastrophizingpotentialmoderatestherelationshipbetween hotflash-interferenceandcancer-relateddistress.Specifically,menwhodidnot anticipatethattheywouldcatastrophizeinresponsetohotflashesexhibiteduniformly lowlevelsofcancer-relateddistress,regardlessofthelevelofinterferenceindaily activitiesduetohotflashes.Incontrast,menwithgreaterpotentialtoengagein catastrophizinginresponsetohotflashesexhibitedlowlevelsofdistresswithlowlevels ofhotflash-relatedinterference,buthighlevelsofdistresswithhighlevelsofhotflashrelatedinterference.

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65 D iscussion Thegoalofthecurrentstudywastoincreaseourunderstandingofmens experienceofhotflasheswhilereceivingandrogendeprivationtherapyforprostate cancer.Hotflashesareanunusualexperienceformostmenandlittleisknownabout theirimpactonpsychologicalfunctioningandqualityoflife.Thecurrentstudy hypothesizedthattheexperienceofhotflashesinthispopulationwouldleadtoincreased distress.Resultswerepartiallyconsistentwiththishypothesis.Thedegreetowhichhot flashesinterferedwithpatientsabilitytoengageintheirdailyactivitiespredicted increasesindepressivesymptomatologyoverthethree-monthstudyperiod;however, noneofthefourhotflashvariables(frequency,severity,score,interference)were successfulinpredictingchangesincancer-relateddistress. Inadditiontoreportsofincreasedpsychologicaldistress,itwasexpectedthatmen reportingaworseexperienceofhotflasheswouldalsoreportgreatersleepdisturbance, fatigue,andsexualdysfunction.Allfourindicesofhotflashexperiencepredicted increasedsleepdisturbance.Hotflash-relatedinterferencewastheonlyvariableto predictincreasesinlevelsofmostfatigue. Therewasnoevidencetosupportthe hypothesisthataworseexperienceofhotflashesleadtoincreasedsexualdysfunction. Inanefforttofurtherunderstandtherelationshipbetweenhotflashesanddistress, weevaluatedpotentialmediatorsofthisrelationship.Resultspartiallysupportedthe hypothesizedmediationalmodels.Thatis,increasesinfatiguewerefoundtomediatethe relationshipbetweenhotflash-relatedinterferenceanddepressivesymptomatology;

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66 h owever,thisvariabledidnotmediatetherelationshipbetweenhotflashesandcancerrelateddistress.Sexualdysfunctiondidnotmediateanyoftheproposedrelationships. Thefinalsetofhypothesesproposedthatcatastrophizingpotentialandmasculine self-imagewouldserveasmoderatorsoftherelationshipbetweenhotflashexperience andpsychologicaldistress.Thesehypotheseswerepartiallysupported.Catastrophizing potentialwasfoundtomoderatetherelationshipbetweenhotflash-relatedinterference andcancer-relateddistress.Formenwhoreportedhighlevelsofcatastrophizing potential,subsequentlevelsofcancer-relateddistressweredependentuponthedegreeto whichhotflashesinterferedwithfunctioning.Menwhoreportedlowlevelsof catastrophizingpotentialexperiencedlowlevelsofcancer-relateddistressregardlessof thedegreetowhichhotflashesinterferedwiththeirdailyfunctioning. Thefollowingdiscussionwillplacethesefindingsincontextwiththeexisting literatureandhighlightthewaysinwhichtheyfurtherourunderstandingofthe psychologicalimpactofhotflashesinmen.Potentialclinicalimplicationsofthese findingswillbediscussedinrelationtothetreatmentofhotflashes.Finally,limitations ofthecurrentstudywillbeoutlinedalongwithsuggestionsforfutureresearch. Thesefindingsaddtothegrowingbodyofresearchdocumentingarelationship betweenreceiptofandrogendeprivationtherapyandpsychologicaldistress(Fowler,et. al.,2002;Herr&OSullivan,2000;Pirl,et.al.,2002).Todate,moststudiesconducted withmenonandrogendeprivationtherapyhavenotattemptedtodifferentiateamongthe constellationofsideeffectsthatoccurasaresultofthisformoftreatment.Ofparticular interestinthecurrentstudywastheimpactofhotflashesonincreasesindistressoverthe three-monthperiodfollowingtheinitiationofandrogendeprivationtherapy.Although

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67 o therstudieshavefoundstrongrelationshipsbetweenfrequencyand/orseverityofhot flashesandmeasuresofpsychologicaldistressinwomenwithbreastcancer,(Carpenter et.al.,1998;Carpenter,et.al.,2002),theserelationshipswerenotaswelldefinedinmen withprostatecancer.Inthepresentstudy,ratingsofhotflash-relatedinterference emergedasthesolesignificantpredictorofincreasesindepression.Thissuggeststhatthe extenttowhichhotflashesinterferewithpatientsdailyfunctioningmaybemore importanttoevaluatethanthefrequencyorseverityofhotflashesinidentifyingmenat riskfordepression.Sincethestudiesconductedtodatehavenottypicallyexaminedthis relationshipinalongitudinalfashion,itisdifficulttomakedirectcomparisonsto previousliterature.Ofrelevancearecross-sectionalstudiesshowingthathotflash-related interferenceispositivelycorrelatedwithnegativeaffectandmooddisturbanceinwomen withbreastcancer(Carpenter,2001)andpoorerqualityoflifeinmenwithprostate cancer(Nishiyama,et.al,2004). Asnotedpreviously,changesinsexualfunctioningfailedtoaccountfor significantvarianceineitherdepressionorcancer-relateddistress.Incomparison,hot flash-relatedinterferenceaccountedforsignificantvarianceindepressive symptomatologyoverthethreemonthstudyperiod.Takentogether,thesefindings suggestthatinterferenceduetohotflashesmayplayalargerroleinthedevelopmentand maintenanceofdepressivesymptomsthansexualproblems.Alongwithhotflashes, sexualdysfunctionisconsideredtobeoneofthemoreprevalentandupsettingside effectsformenreceivingandrogendeprivationtherapy(Fowler,et.al.,2002;Herr& OSullivan,2000;Potosky,et.al.,2001Potosky,et.al.,2002);howevertheoriginsof sexualdysfunctioninthispopulationarelikelytobemultifactorial.Priortreatmentsfor

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68 pr ostatecancer(i.e.prostatectomy,radiation),comorbidhealthconditions,andside effectsfromvariousmedicationsareallpotentialcontributorstothedevelopmentof sexualdysfunction.Impairmentinsexualfunctioningmaypre-datetheinitiationof androgendeprivationtherapyformanyofthesemen;thereforethecurrentstudymaynot havecapturedtheinitialdistressassociatedwiththislossinfunctioning. Resultsofthecurrentstudyprovideevidenceinsupportofpotentialmechanisms bywhichhotflash-relatedinterferencecontributestoincreasesindepression.Levelof fatiguereportedbythesemenmediatedtherelationshipbetweenhotflashesand depression.Nootherstudiescanbeidentifiedthathaveattemptedtoexplorepotential mediatorsoftherelationshipbetweenhotflashesanddistressinmenorwomen. However,consistentwiththecurrentresults,fatiguehasbeenlinkedtohotflashesin cross-sectionalstudiesofwomenwithbreastcancer(Carpenter,et.al.,2004;Stein,et.al. 2000). Theimpactofhotflash-relatedinterferenceoncancer-relateddistressdoesappear todifferasafunctionofuseofcatastrophizingasacopingtool.Resultssuggestthatthe cancer-relateddistressofmenreportinggreateruseofcatastrophizingappearstoincrease ashotflash-relatedinterferenceincreases.Menlowinexpecteduseofcatastrophizing exhibitconsistentlylowlevelsofcancer-relateddistressregardlessofhotflash-related interference.Thesefindingsarelinewiththebodyofliteraturesupportingastrong associationbetweenuseofcatastrophizingandincreasedratingsofpain(Sullivan,Thorn, Haythornthwaite,et.al.,2001).Prospectiveratingsofcatastrophizinghavebeenfoundto predictsubsequentratingsofpaininresponsetodentalproceduresandinindividuals witharthritis(Keefe,et.al.,1989;Su llivan,Bishop,&Pivik, 1995;Sullivan&Neish,

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69 1999) .Asimilarpatternhasbeenfoundinrelationtotheexperienceoffatigueincancer patientpopulations.Inwomenwithbreastcancer,catastrophizinghasbeenfoundto predictmoreseverefatigueinresponsetoradiationtherapy(Jacobsen,Andrykowski,& Thors,2004).Takentogether,thesefindingssupportthenotionthatrelianceon catastrophizingasacopingmechanismcanleadtoamoreintenseexperienceof symptoms. Althoughthisstudyrepresentsanadvanceovermuchofthepreviouscrosssectionalresearchonhotflashesinprostatecancerpatients,certainlimitationsshouldbe consideredwhenevaluatingtheresults.First,becausethisistheinitialstudyto longitudinallyevaluatetheroleofhotflashesinthedevelopmentofdistress,theresults shouldbeconsideredpreliminaryandinneedofreplication.Becausethesamplesizewas relativelysmall,theabilityoftheseresultstogeneralizetothebroadpopulationof prostatecancerpatientsisunknown.Despitethesmallsamplesize,however,the demographicmake-upwasfairlydiverseintermsofethnicityandincome. Second,thepresentstudyusedsubjectiveratingsofhotflashpresence,frequency, andseverity.Thefactthattheseself-reportratingsofhotflashesweremade retrospectivelyintroducesanelementofrecallbias.Althoughsomeinvestigationsutilize dailydiariesinordertocombatthisproblem(Carpenter,et.al.,2001;Sloan,et.al., 2001),non-adherenceandmissingdatawereofsignificantconcernwiththispopulation. Althoughobjectivephysiologicalassessmenttoolssuchassternalskinconductance monitoringcanbeusedtomeasurehotflashes(Carpenter,Andrykowski,Freedman,& Munn,1999;Carpenter,Monahan,&Azzouz,2004;Coyne,2005),thisformof assessmentisnotwithoutitslimitations.ArecentreportbytheNationalInstitutesof

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70 H ealthpointsoutthatsternalskinconductancemonitoringfailstocaptureimportant informationsuchasperceivedseverityandinterferencewithdailyactivities(Miller&Li, 2004).Thismethodalsoposesconsiderableburdenonresearchparticipants,requiring frequenthomevisitsbystudypersonneltoadjusttheequipmentandreadthedata,aswell aspotentialdiscomfortwithelectrodes. Itshouldalsobenotedthatthehotflashvariables(predictors),distressvariables (outcomes),andpotentialmediatorsandmoderatorswereassessedconcurrently; therefore,causalrelationshipsamongthesevariablescannotbeconclusivelydetermined. Incorporationofdailydiariesorreal-timedatacollectiontechnology(e.g.palm-sized datarecordingdevices)wouldmoreaccuratelyallowforevaluationofthetemporal relationshipbetweenhotflashes,fatigue,andpsychologicaldistress.Thistypeof repeatedassessmentwouldmoreclearlydemonstratetherelationshipbetweentheonset ofhotflashesandsubsequentdevelopmentoffatigueanddepression. Athirdlimitationofthecurrentstudywastheheterogeneityofthesamplein termsofstageofillness,timesincediagnosis,andtreatmenthistory.Thesemenwereat differentstagesoftheirdiseasetrajectoryandthereforemaynothavebeenrespondingto theonsetofanewsetofsideeffectsinthesamemanner.Menwhohadbeenlivingwitha prostatecancerdiagnosisforanumberofyearsmayhavebeenlessdistressedbyhot flashes,astheymayhavehadtimetoadjusttothelimitationsimposedbyprostatecancer anditstreatment.Despitethisapparentdiversity,timesincediagnosisdidnotprovetobe asignificantcorrelateofpsychologicaldistressoranyofthehotflashvariables. Studieshaveshownthathotflashesdonotgenerallysubsideastimesince treatmentincreases(Karling,Hammar&Varenhorst,1994;Spetz,et.al.,2001);

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71 t herefore,itisimportanttorecognizetheimpactofthistreatment-relatedsideeffectand todevelopappropriateandeffectiveremedies.Preliminaryevidencelendssupporttothe useofpharmacologicalagentsinreducinghotflashesinmen,includingmegestrol acetate,asyntheticprogesterone(Loprinzi,et.al.,1994),aswellasanti-depressantssuch asparoxetine(Loprinzi,et.al.,2004)andvenlafaxine(Quella,et.al.,1999).Despitetheir apparentsuccessinreducingtheincidenceofhotflashes,thesemedicationscomewith theirownsetofsideeffects;includingnausea,drymouth,decreasedappetite,and constipation.Furthermore,awelldocumentedplaceboeffectinhotflashstudies estimatesa20-30%reductioninhotflashscorewithfourweeksofaplacebo(Sloan,et. al.,2001).Thesubstantialplaceboeffectandpotentiallyaversivesideeffectsfrom pharmacologicalagentsspeaktotheneedforbehavioralinterventionsdesignedtoreduce hotflashes. Resultsofthepresentstudysuggestseveraladditionalavenuesforclinical intervention.Fatigueandcatastrophizing,inparticular,appeartobepromisingareasof exploration.Resultsofmediationanalysissuggestthatreducingfatiguewould significantlydecreaseoreliminatetherelationshipbetweenhotflash-relatedinterference andincreasedsymptomsofdepression.Routinephysicalactivityhaslongbeenregarded asaneffectivemethodofenhancingmood,sleepquality,andoverallqualityoflife.A recentstudyhasexaminedtheutilityofexerciseinaprostatecancerpopulation(Segal, Reid,Courneya,et.al.,2003).Inasampleofinmenreceivingandrogendeprivation, participationina12-weekresistanceexerciseprogramledtoimprovementsinsymptoms offatigueandqualityofliferelativetoawaitlistcontrolcondition.Thisinitial investigationlendsfurthersupporttothebeneficialqualitiesofphysicalactivity;

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72 ho wever,ahighlystructuredprogramsuchasthismaynotbefeasibleinmanyoutpatient settings.Futurestudiesshouldexploretheefficacyoflessintensiveinterventionsthat wouldgeneralizetoabroaderrangeofsettings. Resultsfurtherindicatethatuseofcatastrophizingmaydeterminetheamountof cancer-relateddistressexperiencedbythepatient.Thishasseveralimplicationsfor clinicalpractice.Assessmentofcatastrophizingmaybeusefulinidentifyingprostate cancerpatientsatriskfordevelopinghighlevelsofcancer-relateddistresswhile receivingandrogendeprivationtherapy.Thiscanbeaccomplishedbyhavingthepatient completeabrief10-itemmeasurepriortotheinitiationoftreatment.Patientsidentifiedas pronetocatastrophizingmaybenefitfromabriefpsycho-educationalintervention designedtopromoteuseofmoreadaptivecopingresponses.Resultsofarecent randomizedcontrolledtrialincorporatingbothactivephysicaltreatmentandcognitivebehavioraltreatmentwaseffectiveinreducingpaincatastrophizinginasampleof patientswithnonspecificchroniclowbackpain(Smeets,Vlaeyen,Kester,&Knottnerus, 2006).Changeinpaincatastrophizingwasfoundtomediatethereductionofdisability, paincomplaints,andpainintensity.Similarinterventionsdesignedtoreducehotflash catastrophizingmayresultinlowerlevelsofcancer-relateddistress. Thefindingspresentedhererepresentanimportantfirststeptowards understandingtheroleofhotflashesinthedevelopmentofpsychologicaldistressinmen receivingandrogendeprivationtherapyforprostatecancer.Prevalenceratesof depressioninthispopulationarethoughttobearound12-13%(Pirl,et.al.,2002). Therefore,itisimportanttounderstandthefactorsthatcontributetoandmaintainthese symptoms.Theextenttowhichhotflashesinterferewiththepatientsabilitytoengagein

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73 r outinedailyactivitiesappearstobethemostsignificantfactorindeterminingincreases indepressivesymptomatology.Resultsofmediationanalysessuggestthatincreased fatiguepartiallyexplainstherelationshipbetweenhotflash-relatedinterferenceand symptomsofdepressioninmenreceivingthisformoftreatmentforprostatecancer. Furthermore,thecopingstrategyofcatastrophizingappearstomoderatetherelationship betweenhotflash-relatedinterferenceandincreasesincancer-relateddistress.Additional researchisneededtorealizethepotentialofthesefindingsinclinicalpopulations.

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76 G aston-Johansson,F.,Ohly,K.V.,Fall-Dickson,J.M.,Nanda,J.P.,&Kennedy, M.J.(1999).Pain,psychologicaldistress,healthstatus,andcopinginpatientswithbreast cancerscheduledforautotransplantation. OncologyNursingForum,26,1337-1345. Green,H.J.,Pakenham,K.I.,Headley,B.C.,Yaxley,J.,Nicol,D.L.,MacTaggart, P.N.,Swanson,C.,Watson,R.B.,&Gardiner,R.A.(2002).Alteredcognitivefunctionin mentreatedforprostatecancerwithluteinizinghormone-releasinghormoneanalogues andcyproteroneacetate:arandomizedcontrolledtrial. BJUInternational,90 ,427-432. Hann,D.,Winter,K.,&Jacobsen,P.(1999).Measurementofdepressive symptomsincancerpatients:EvaluationoftheCenterforEpidemiologicalStudies DepressionScale(CES-D). JournalofPsychosomaticResearch,46 ,437-443. Harder,H.,Cornelissen,J.J.,VanGool,A.R.,Duivenvoorden,H.J.,Eijkenboom, W.M.H.,&vandenBent,M.J.(2002).Cognitivefunctioningandqualityoflifeinlongtermadultsurvivorsofbonemarrowtransplantation. Cancer,95(1) ,183-192. Hellerstedt,B.A.&Pienta,K.J.(2002).Thecurrentstateofhormonaltherapyfor prostatecancer. CACancerJClin,52 ,154-179. Herr,H.W.,Kornblith,A.B.,Ofman,U.(1993).AcomparisonoftheQOLof patientwithmetastaticprostatecancerwhoreceivedordidnotreceivehormonaltherapy. Cancer,71 ,1143-1150. Herr,H.W.&OSullivan,M.(2000).Qualityoflifeofasymptomaticmenwith nonmetastaticprostatecanceronandrogendeprivationtherapy. TheJournalofUrology, 163,1743-1746. Holt,C.L.&Ellis,J.B.(1998).AssessingthecurrentvalidityoftheBemSexRoleInventory. SexRoles:AJournalofResearch,39,929-941. Horowitz,M.,Wilner,N.,&Alvarez,W.(1979).Impactofeventscale:a measureofsubjectivestress. PsychosomaticMedicine,41 ,209-218. Jacobsen,P.B.,Andrykowski,M.A.,&Thors,C.L.(2004).Relationshipof catastrophizingtofatigueamongwomenreceivingtreatmentforbreastcancer. Journalof ConsultingandClinicalPsychology,72 ,355-361. Jacobsen,P.B.,Azzarello,L.M.,&Hann,D.M.(1999).Relationof catastrophizingtofatigueseverityinwomenwithbreastcancer. CancerResearch Therapy&Control,8 ,155-164. JacobsenP.B.&Butler,R.W.(1996).Relationofcognitivecopingand catastrophizingtoacutepainandanalgesicusefollowingbreastcancersurgery. Journal ofBehavioralMedicine,19 ,17-29.

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77 K arling,P.,Hammar,M.,&Varenhorst,E.(1994).Prevalenceanddurationof hotflushesaftersurgicalormedicalcastrationinmenwithprostaticcarcinoma. The JournalofUrology,152 ,1170-1173. Keefe,F.J.,Brown,G.K.,Wallston,K.A.,&Caldwell,D.S.(1989).Copingwith rheumatoidarthritis:Catastrophizingasamaladaptivestrategy. Pain,37 ,51. Kronenberg,F.(1994).Hotflashes:phenomenology,qualityoflife,andsearch fortreatmentoptions. ExperimentalGerontology,29 ,319-36. Legler,J.,Potosky,A.L.,Gilliland,F.D.,Eley,J.W.,&Stanford,J.L.(2000). Validationstudyofretrospectiverecallofdisease-targetedfunction:resultsfromthe prostatecanceroutcomesstudy. MedicalCare,38 ,847-857. Lin,C.C.(1998).Comparisonoftheeffectsofperceivedself-efficacyoncoping withchroniccancerpainandcopingwithchroniclowbackpain. ClinicalJournalof Pain,14 ,303-310. Litwin,M.S.,Hays,R.D.,Fink,A.,Ganz,P.A.,Leake,B.,Boork,R.H.(1998). TheUCLAProstateCancerIndex:development,reliability,andvalidityofahealthrelatedqualityoflifemeasure. MedicalCare,36 ,1002-1012. Loprinzi,C.L.,Barton,D.L.,Carpenter,L.A.,Sloan,J.A.,Novotny,P.J., Gettman,M.T.,&Christensen,B.J.(2004).Pilotevaluationofparoxetinefortreatinghot flashesinmen. MayoClinicProceedings,79 ,1247-1251. Loprinzi,C.L.,Michalak,J.C.,Quella,S.K.,OFallon,J.R.,Hatfield,A.K., Nelimark,R.A.,Dose,A.M.,Fischer,T.,Johnson,C.,Klatt,N.E.,Bate,W.W.,Rospond, R.M.,&Oesterling,J.E.(1994).Megestrolacetateforthepreventionofhotflashes. New EnglandJournalofMedicine,331 ,347-352. Lubeck,D.P.,Grossfeld,G.D.,&Carroll,P.R.(2001).Theeffectofandrogen deprivationtherapyonhealth-relatedqualityoflifeinmenwithprostatecancer. Urology, 58,94-100. Miller,H.G.&Li,R.M.(2004).Measuringhotflashes:summaryofaNational InstitutesofHealthworkshop. MayoClinicProceedings,79 ,777-781. Nishiyama,T.Kanazawa,S.,Wantanabe,R.,Terunuma,M.,&Takahashi,K. (2004).Influenceofhotflashesonqualityoflifeinpatientswithprostatecancertreated withandrogendeprivationtherapy. InternationalJournalofUrology,11 ,735-741. Pirl,W.F.,Siegel,G.I.,Goode,M.J.,&Smith,M.R.(2002).Depressioninmen receivingandrogendeprivationtherapyforprostatecancer:Apilotstudy. PsychoOncology,11,518-523.

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78 P ortenoy,R.K.,Thaler,H.T.,Kornblith,A.B.,McCarthyLepore,J.,FriedlanderKlar,H.,Kiyasu,E.,Sobel,K.,Coyle,N.,Kemeny,N.,Norton,L.,&Scher,H.(1994). TheMemorialSymptomAssessmentScale:aninstrumentfortheevaluationofsymptom prevalence,characteristics,anddistress. EuropeanJournalofCancer,30A ,1326-1336. Potosky,A.L.,Harlan,L.C.,Stanford,J.L.,Gilliland,F.D.,Hamilton,A.S., Albertsen,P.C.,Eley,J.W.,Liff,J.M.,Deapen,D.,Stephenson,R.A.,Legler,J.,Ferrans, C.E.,Talcott,J.A.,&Litwon,M.S.(1999).Prostatecancerpracticepatternsandquality oflife:Theprostatecanceroutcomesstudy. JournaloftheNationalCancerInstitute,91 1719-1724. Potosky,A.L.,Knopf,K.,Clegg,L.X.,Albertsen,P.C.,Stanford,J.L.,Hamilton, A.S.,Gililand,F.D.,Eley,J.W.,Stephenson,R.A.,&Hoffman,R.M.(2001).Quality-oflifeoutcomesafterprimaryandrogendeprivationtherapy:Resultsfromtheprostate canceroutcomesstudy. JournalofClinicalOncology,19 ,3750-3757. Potosky,A.L.,Reeve,B.B.,Clegg,L.X.,Hoffman,R.M.,Stephenson,R.A., Albertsen,P.C.,Gilliland,F.D.,&StanfordJ.L.(2002).Qualityoflifefollowing localizedprostatecancertreatedinitiallywithandrogendeprivationtherapyorno therapy. JournaloftheNationalCancerInstitute,94 ,430-437. Quella,S.K.,Loprinzi,C.L.,Sloan,J.,Novotny,P.,Perez,E.A.,Burch,P.A., Antolak,S.J.,Pisansky,T.M.(1999).Pilotevaluationofvenlafaxineforthetreatmentof hotflashesinmenundergoingandrogenablationtherapyforprostatecancer. Journalof Urology,162 ,98-102. Radloff,L.S.(1977).TheCES-DScale:aself-reportdepressionscaleforresearch inthegeneralpopulation. AppliedPsychologicalMeasurement,1 ,119-135. Sabo,D.(2000).Menshealthstudies:Originsandtrends. JournalofAmerican CollegeHealth,49,133-142. Sabo,D.&Gordon,D.F.(1995). MensHealthandIllness:Gender,Power,and theBody .ThousandOaks,CA:SagePublications,Inc. Segal,R.J.,Reid,R.R.,Courneya,K.S.,Malone,S.C.,Parliament,M.B.,Scott, C.G.,Venner,P.M.,Quinney,H.A.,Jones,L.W.,DAngelo,S.,Wells,G.A.(2003). Resistanceexerciseinmenreceivingandrogendeprivationtherapyforprostatecancer. JournalofClinicalOncology,21 ,1653-1659. Sloan,J.A.,Loprinzi,C.L.,Novotny,C.L.,Barton,D.L.,Lavasseur,B.I.,& Windschitl,H.(2001).Methodologiclessonslearnedfromhotflashstudies. Journalof ClinicalOncology,19 ,4280-4290.

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79 S meets,R.J.,Vlaeyen,J.W .,Kester,A.D .,&Knottnerus,J.A .(2006).Reduction ofpaincatastrophizingmediatestheoutcomeofbothphysicalandcognitive-behavioral treatmentinchroniclowbackpain. TheJournalofPain,7 ,261-271. Sobel,M.E.(1982).Asymptoticconfidenceintervalsforindirecteffectsin structuralequationmodels.InS.Leinhardt(Ed.), SociologicalMethodology (pp.290312).WashingtonDC:AmericanSociologicalAssociation. Spetz,A.C.,Hammar,M.,Lindberg,B.,Spangberg,A.,Varenhorst,E.&The ScandinavianProstaticCancerGroup-5TrialStudy.(2001).Prospectiveevaluationofhot flashesduringtreatmentwithparenteralestrogenorcompleteandrogenablationfor metastaticcarcinomaoftheprostate. TheJournalofUrology,166 ,517-520. Stansbury,J.P.,Mathewson-Chapman,M.,Grant,K.E.(2003).Genderschema andprostatecancer:veterans'culturalmodelofmasculinity. MedicalAnthropology,22, 175-204. Stein,K.D.,Jacobsen,P.B.,Hann,D.M,Greenberg,H.,&Lyman,G.(2000). Impactofhotflashesonqualityoflifeamongpostmenopausalwomenbeingtreatedfor breastcancer. JournalofPainandSymptomManagement,19 ,436-445. Stone,P.,Hardy,J.,Huddart,R.,AHern,R.,Richards,M.(2000).Fatiguein patientswithprostatecancerreceivinghormonetherapy. EuropeanJournalofCancer, 36,1134-1141. Sullivan,M.J.L.,Bishop,S.R.,&Pivik,J.( 1995).ThePainCatastrophizing Scale:Developmentandvalidation. PsychologicalAssessment,7 ,524-532. SullivanM.J.L.&Neisch,N.( 1999). The effects of disclosure on pain during dental hygiene treatment: the mode rating role of catastrophizing. Pain,79, 155. Sullivan,M.J.L.,Thorn,B.,Haythornthwaite,J.A.,Keefe,F.,Martin,M., Bradley,L.A.,Lefebvre,J.C.(2001).Theoreticalperspectivesontherelationbetween catastrophizingandpain. TheClinicalJournalofPain,17 ,52-64. Thewes,B.,Meiser,B.,&Hickie,I.B.(2001).Psychometricpropertiesofthe ImpactofEventScaleamongstwomenatincreasedriskforhereditarybreastcancer. Psycho-Oncology,10 ,459-468. Wei,J.T.,Dunn,R.L.,Litwin,M.S.,Sandler,H.M.,&Sanda,M.G.(2000). DevelopmentandvalidationoftheExpandedProstateCancerIndexComposite(EPIC) forcomprehensiveassessmentofhealth-relatedqualityoflifeinmenwithprostate cancer. Urology,56 ,899-905.

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80 W eitzner,M.A.,Moncello,J.,Jacobsen,P.B.,&Minton,S.(2002).Apilottrial ofparoxetinefortreatmentofhotflashesandassociatedsymptomsinwomenwithbreast cancer. JournalofPainandSymptomManagement,23 ,337-345. Wilkie,D.J.&Keefe,F.J.(1991).Copingstrategiesofpatientswithlungcancerrelatedpain. ClinicalJournalofPain,7 ,292-299. Wingard,J.R.,Curbow,B.,Baker,F.,&Piantadosi,S.(1991).Health,functional status,andemploymentofadultsurvivorsofbonemarrowtransplantation. Annalsof InternalMedicine,114, 113-118.

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81 A ppendices

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82 Ap pendixA:InformedConsentforMoffittCancerCenter InformedConsent SocialandBehavioralSciences UniversityofSouthFlorida InformationforPeopleWhoTakePartinResearchStudies Thefollowinginformationisbeingpresentedtohelpyoudecidewhetherornotyouwant totakepartinaminimalriskresearchstudy.Pleasereadthiscarefully.Ifyoudonot understandanything,askthepersoninchargeofthestudy. TitleofStudy: Characteristicsandcorrelatesofhotflashesinmenwithprostatecancer PrincipalInvestigator: PaulB.Jacobsen,Ph.D. StudyLocation(s): H.LeeMoffittCancerCenter Youarebeingaskedtoparticipatebecauseyouhavebeendiagnosedwithprostatecancer andarebeingtreatedwithhormonaltherapy. GeneralInformationabouttheResearchStudy Thepurposeofthisresearchstudyistodeterminetheprevalenceandseverityofhot f lashesexperiencedbymenbeingtreatedwithhormonaltherapy.Wewouldalsoliketo understandtheimpactthesehotflashesmayhaveonvariousaspectsofyourqualityof life. PlanofStudy Youwillbeaskedtocompleteapacketofquestionnairespriortostartinghormonal therapy.Twoweeksafteryoubegintreatment,youwillbeaskedtorespondtosome questionsregardingtheprevalenceandseverityofthehotflashesyoumaybe experiencing.Onemonthafteryouhavestartedtreatment,youwillbeaskedtocomplete asecondpacketofquestionnaires,similarincontenttothefirstpacket.Thesecondtwo assessmentsmaybecompletedinclinicoronthetelephone. PaymentforParticipation Youwillnotbepaidforyourparticipationinthisstudy.

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83 Ap pendixA:(Continued) BenefitsofBeingaPartofthisResearchStudy Bytakingpartinthisstudy,youwillincreaseourknowledgeregardingtheexperienceof hotflashesinmenwithprostatecancer. RisksofBeingaPartofthisResearchStudy Therearenounpleasantorharmfulsideeffectsfromparticipatinginthisstudy. Conf identialityofYourRecords Yourprivacyandresearchrecordswillbekeptconfidentialtotheextentofthelaw. Authorizedresearchpersonnel,employeesoftheDepartmentofHealthandHuman Services,andtheUSFInstitutionalReviewBoardmayinspecttherecordsfromthis researchproject. Theresultsofthisstudymaybepublished.However,thedataobtainedfromyouwillbe combinedwithdatafromothersinthepublication.Thepublishedresultswillnotinclude yournameoranyotherinformationthatwouldpersonallyidentifyyouinanyway. Yournamewillnotappearonanyresearchformexceptforthisinformedconsentform andamasterlist,whichwillbemaintainedinalockedresearchfile. VolunteeringtoBePartofthisResearchStudy Yourdecisiontoparticipateinthisresearchstudyiscompletelyvoluntary.Youarefree toparticipateinthisresearchstudyortowithdrawatanytime.Therewillbenopenalty orlossofbenefitsyouareentitledtoreceive,ifyoustoptakingpartinthestudy.Your medicalcarewillnotbeaffected. QuestionsandContacts Ifyouhaveanyquestionsaboutthisresearchstudy,contactErinWinters,M.A.at 1-800-456-3434x6187 Ifyouhavequestionsaboutyourrightsasapersonwhoistakingpartina researchstudy,youmaycontacttheDivisionofResearchComplianceofthe UniversityofSouthFloridaat(813)974-5638. ConsenttoTakePartinThisResearchStudy B ysigningthisformIagreethat:

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84 Ap pendixA:(Continued) Ihavefullyreadorhavehadreadandexplainedtomethisinformedconsentform describingthisresearchproject. Ihavehadtheopportunitytoquestiononeofthepersonsinchargeofthis researchandhavereceivedsatisfactoryanswers. IunderstandthatIambeingaskedtoparticipateinresearch.Iunderstandthe risksandbenefits,andIfreelygivemyconsenttoparticipateintheresearch projectoutlinedinthisform,undertheconditionsindicatedinit. Ihavebeengivenasignedcopyofthisinformedconsentform,whichismineto keep. ___________________ ________________________________ SignatureofParticipant PrintedNameofParticipantDate InvestigatorStatement Ihavecarefullyexplainedtothesubjectthenatureoftheaboveresearchstudy.Ihereby certifythattothebestofmyknowledgethesubjectsigningthisconsentformunderstands thenature,demands,risks,andbenefitsinvolvedinparticipatinginthisstudy. ___________________ __________________________________ SignatureofInvestigator PrintedNameofInvestigatorDate Orauthorizedresearch investigatordesignatedby thePrincipalInvestigator

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85 A pendixB:InformedConsentforJamesA.HaleyVeteransHospital InformedConsentforanAdult UniversityofSouthFlorida,theIRBofrecordfortheJamesA.HaleyVAHospital Informationforpeoplewhoarebeingaskedtotakepartinaresearchstudy IRBStudy#_103119___ ResearchersattheJamesA.HaleyVAHospitalstudymanytopics.Wewanttolearn moreabouthowhormonaltherapyforprostatecanceraffectsourpatients.Todothis,we needthehelpofpeoplewhoagreetotakepartinaresearchstudy. Personinchargeofstudy: RaoulSalup,M.D. Studystaffwhocanactonbehalfofthepersonincharge: ErinWinters,M.A.,Sean Ransom,M.A.,BabuZachariah,M.D.,JoyceShaw,PaulJacobsen,Ph.D. Wherethestudywillbedone: JamesA.HaleyVeteransHospital Whoispayingforit: Notapplicable Shouldyoutakepartinthisstudy? Thisformtellsyouaboutthisresearchstudy.Youcandecideifyouwanttotakepartin it.Youdonothavetotakepart.Readingthisformcanhelpyoudecide. Beforeyoudecide: Readthisform. Talkaboutthisstudywiththepersoninchargeofthestudyorthepersonexplaining thestudy.Youcanhavesomeonewithyouwhenyoutalkaboutthestudy. Findoutwhatthestudyisabout. Youcanaskquestions: Youmayhavequestionsthisformdoesnotanswer.Ifyoudo,askthepersonin chargeofthestudyorstudystaffasyougoalong. Youdonthavetoguessatthingsyoudontunderstand.Askthepeopledoingthe studytoexplainthingsinawayyoucanunderstand. Afteryoureadthisform,youcan: Takeyourtimetothinkaboutit. Haveafriendorfamilymemberreadit. Talkitoverwithsomeoneyoutrust. Itsuptoyou.Ifyouchoosetobeinthestudy,thenyoucansigntheform.Ifyoudonot wanttotakepartinthisstudy,donotsigntheform.

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86 Ap pendixB:(Continued) Whyisthisresearchbeingdone? Thepurposeofthisstudyistofindouthowthehotflashesassociatedwithhormonal therapyaffectthemood,energylevel,sleepquality,sexualfunctioning,anddaily activitiesofpatientswithprostatecancer. Whyareyoubeingaskedtotakepart? Weareaskingyoutotakepartinthisstudybecauseyouarescheduledtoundergo hormonaltherapyfortreatmentofprostatecancer.Weareinterestedinunderstanding howthesideeffectsassociatedwiththisformoftreatmentimpactvariousaspectsofyour qualityoflife. Howlongwillyoubeaskedtostayinthestudy? Youwillbeaskedtospendaboutthreemonthsinthisstudy.Thisconsistsoftheperiod oftimebetweentheinitialadministrationofhormonaltherapyandyourfirstclinical follow-upvisit.Youwillbeassessedpriortobeginninghormonaltherapyandagainsix weeksandthreemonthsaftertreatmenthasstarted. Howoftenwillyouneedtocomeforstudyvisits? Astudyvisitisoneyouhavewiththepersoninchargeofthestudyorstudystaff.You willneedtocomefor2studyvisitsinall. Youwillbeaskedtofilloutapacketofquestionnairesthatwilltake25-30minutesto complete.YoucaneitherfinishthequestionnaireswhileyouareattheVA,oryoumay takethemhomewithyouandreturnthembymail.Approximatelysixweeksafterthis initialassessment,youwillbecontactedathomebytelephoneandwillbeaskedtoreport onprevalenceandseverityofthehotflashesyoumaybeexperiencing. Moststudyvisitswilltakeabout30minutes.Somemaybelonger. Ateachvisit,thepersoninchargeofthestudyorstaffwill: Provideyouwithapacketofquestionnaires.Thesequestionnaireswillassessbasic demographicinformation(age,gender,maritalstatus,etc),diseaseandtreatment variables,hotflashes,hotflashinterference,fatigue,sleepquality,psychological distress,masculineself-image,copingstrategies,sexualfunctioning,treatmentrelatedsideeffects,andcognitivefunctioning. Inbetweenthe2studyvisits,amemberoftheresearchteamwillcontactyouat home.Atthispoint,youwillbeaskedtorespondtoquestionsregardinganyhot flashesyoumaybeexperiencing,andhowtheyareimpactingyourdailyactivities.

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87 Ap pendixB:(Continued) Howmanyotherpeoplewilltakepart? About65peoplewilltakepartinthisstudyatJamesA.HaleyVAHospital.Peoplewill alsotakepartatotherstudysites.Atotalofabout89peoplewilltakepart. Whatotherchoicesdoyouhaveif youdecidenottotakepart? Ifyoudecidenottotakepartinthisstudy,thatisokay.Yourtreatmentwillnotbe affectedifyouchosenottoparticipate. Howdoyougetstarted? Ifyoudecidetotakepartinthisstudy,youwillneedtosignthisconsentform.Youwill filloutthefirstquestionnairepacketbeforeyouarestartedonhormonaltherapy. Whatwillhappenduringthisstudy? Duringthestudy,youwillbeaskedtorespondtoanumberofquestionsregardinghot flashes,yourmood,sleep,physicalfunctioning,andsexualfunctioning.Youwillfillout aquestionnairepacketatthebeginningofthestudyandthesamepacketagainattheend ofthestudy.Thesequestionnaireswillrequireapproximately25to30minutesto complete.Sixweeksafterthestartofyourtreatment,youwillbecontactedbytelephone torespondtoafewofthesesamequestions.Thistelephonecallwilltakeapproximately 5-10minutes.Themedicaltreatmentyoureceivewillbethesamewhetherornotyou chosetoparticipate. Hereiswhatyouwillneedtododuringthisstudy Studyparticipationrequirescompletingtwoquestionnairepacketsandonebrief telephoneinterview. Willyoubepaidfortakingpartinthisstudy? Wewillnotpayyouforthetimeyouvolunteerinthisstudy. Whatwillitcostyoutotakepartinthisstudy? It willnotcostyouanythingtotakepartinthestudy. Whatarethepotentialbenefitsifyoutakepartinthisstudy? Althoughtherearenodirectbenefitstoyou,bytakingpartinthisstudy,youwillincrease ourknowledgeregardingtheexperienceofhotflashesinmenwithprostatecancer.What welearnmayhelpotherswiththisstageofprostatecancer.

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88 Ap pendixB:(Continued) Whataretherisksifyoutakepartinthisstudy? Althoughwedonotexpecttheretobeanyunpleasantorharmfulsideeffectsfrom participatinginthisstudy,youmayexperiencesomepsychologicaldiscomfortfrom fillingoutsomeofthequestionnaires. Whatwillwedotokeepyourstudyrecordsfrombeingseenbyothers? Federallawrequiresustokeepyourstudyrecordsprivate.Participantswillbeassigneda three-digitcodenumberthatwillbeusedonallstudymaterials.Informedconsent documentswillbemaintainedinalockedresearchfileinasecureareaoftheMoffitt ResearchCenterbuilding.Completedquestionnaireswillbestoredinadifferentfile, separatedfromanyidentifyinginformation.Researchdatawillbeenteredintoadata analysisprogram.Thisdatawillbeenteredusingthethree-digitcodenumber;no identifyinginformationwillbestoreddigitally.Theprivacyandresearchrecordsofthe participantswillbekeptconfidentialtotheextentofthelaw. However,certainpeoplemayneedtoseeyourstudyrecords.Bylaw,anyonewholooks atyourrecordsmustkeepthemconfidential.Theonlypeoplewhowillbeallowedtosee theserecordsare: Thestudystaff. Peoplewhomakesurethatwearedoingthestudyintherightway.Theyalsomake surethatweprotectyourrightsandsafety: o TheUSFInstitutionalReviewBoard(IRB)anditsstaff o TheDepartmentofVeteransAffairs(VA) o TheUnitedStatesDepartmentofHealthandHumanServices(DHHS) Wemaypublishwhatwefindoutfromthisstudy.Ifwedo,wewillnotuseyourname oranythingelsethatwouldletpeopleknowwhoyouare. Whathappensifyoudecidenottotakepartinthisstudy? Youshouldonlytakepartinthisstudyifyouwanttotakepart. Ifyoudecidenottotakepart: Youwontbeintroubleorloseanyrightsyounormallyhave. Youwillstillgetthesameservicesyouwouldnormallyhave. Youcanstillgetyourregularmedicaltreatment.

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89 Ap pendixB:(Continued) Whatifyoujointhestudyandthenlaterdecideyouwanttostop? Ifyoudecideyouwanttostoptakingpartinthestudy,tellthestudystaffassoonasyou can. Wewilltellyouhowtostopsafely.Wewilltellyouifthereareanydangersifyou stopsuddenly. Ifyoudecidetostop,youcangoongettingyourregularmedicaltreatment. Aretherereasonswemighttakeyououtofthestudylateron? Evenifyouwanttostayinthestudy,theremaybereasonswewillneedtotakeyouout ofit.Youmaybetakenoutofthisstudy: Ifwefindoutitisnotsafeforyoutostayinthestudy.Forexample,yourhealthmay getworse. Ifyouarenotcomingforyourstudyvisitswhenscheduled. Youcangettheanswerstoyourquestions. Ifyouhaveanyquestionsaboutthisstudy,callDr.RaoulSalupat(813)972-2000x7579. Ifyouhavequestionsaboutyourrightsasapersonwhoistakingpartinastudy,callUSF ResearchComplianceat(813)974-5638. YoumayalsocontacttheJamesA.HaleyVAHospitalResearchComplianceOfficerat (813)972-2000ext.7872. SignaturesforConsenttoTakePartinthisResearchStudy Itsuptoyou.Youcandecideifyouwanttotakepartinthisstudy. Ifreelygivemyconsenttotakepartinthisstudy.Iunderstandthatthisisresearch. Ihavereceivedacopyofthisconsentform. ___________________________________________ ___________ SignatureofPersonTakingPartinStudy Date ___________________________________________ PrintedNameofPersonTakingPartinStudy ______________________________________________________ SignatureofWitness Date

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90 Ap pendixB:(Continued) ___________________________________________ PrintedNameofWitness StatementofPersonObtainingInformedConsent Ihavecarefullyexplainedtothepersontakingpartinthestudywhathecanexpect. Thepersonwhoisgivingconsenttotakepartinthisstudy Understandsthelanguagethatisused. Readswellenoughtounderstandthisform.Orisabletohearandunderstandwhen theformisreadtohimorher. Doesnothaveanyproblemsthatcouldmakeithardtounderstandwhatitmeansto takepartinthisstudy. Isnottakingdrugsthatmakeithardtounderstandwhatisbeingexplained. Tothebestofmyknowledge,whenthispersonsignsthisform,heorsheunderstands: Whatthestudyisabout. Whatneedstobedone. Whatthepotentialbenefitsmightbe. Whattheknownrisksmightbe. Thattakingpartinthestudyisvoluntary. _____________________________________________________ Signatureofpersonobtainingconsent Date ___________________________________________ Printednameofpersonobtainingconsent

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91 A ppendixC:ResearchAuthorizationforMoffittCancerCenterCharacteristicsandcorrelatesofhotflashesinmenwithprostatecancerH.LeeMoffittCancerCenterandResearchInstitute attheUniversityofSouthFlorida RESEARCHAUTHORIZATION W eunderstandthatinformationaboutyouandyourhealthispersonal,andweare committedtoprotectingtheprivacyofthatinformation.Becauseofthiscommitment,we mustobtainyourwrittenauthorizationbeforewemayuseordiscloseyourprotected healthinformationfortheresearchpurposesdescribedbelow.Thisformprovidesthat authorizationandhelpsusmakesurethatyouareproperlyinformedofhowthis informationwillbeusedordisclosed. ResearchundertakenattheH.LeeMoffittCancerCenterandResearchInstitute,Inc.or atanyofitssubsidiariesisundertakenjointlywiththeUniversityofSouthFloridaor otherpersonsorentitiesunderanorganizedhealthcarearrangement.Allpersonsor entitiesparticipatinginsuchanorganized healthcarearrangementarecollectively referredtoasthe"MoffittCancerCenter"inthisform. BysigningthisdocumentyouarepermittingtheMoffittCancerCenter tousepersonal healthinformationcollectedaboutyouforresearchpurposesinternallywithinits organizedhealthcarearrangements.YouarealsoallowingtheMoffittCancerCenterto disclosethatpersonalhealthinformationtooutsideorganizationsorindividualsthat participateinthisresearchstudy.Pleasereadtheinformationbelowcarefullybefore signingthisform. USEANDDISCLOSURECOVERE DBYTHISAUTHORIZATION ArepresentativeoftheMoffittCancerCentermustanswerthesequestionscompletely beforeprovidingthisauthorizationformtoyou.DONOTSIGNABLANKFORM.You oryourpersonalrepresentativeshouldreadthedescriptionsbelowbeforesigningthis form. Whowilldisclose,receive,and/orusetheinformation? TheworkforceoftheMoffitt C ancerCenterispermittedbylawtouseanddiscloseyourhealthinformationfor treatment,paymentandhealthcareoperationspurposes.Bysigningbelow,you authorizetheMoffittCancerCentertoreceiveandobtaintests,resultsandyourother personalhealthandrelatedinformationarisingfromservicesortreatmentprovidedto youbyotherhealthcareprovidersinconnectionwiththisstudy.Inadditiontoanyuses

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92 Ap pendixC:(Continued) ordisclosuresmadefortreatment,paymentandhealthcareoperationspurposes,the followingperson(s),class(es)ofpersons,and/ororganization(s)willbeallowedto disclose,use,andreceivetheinformationfortheresearchpurposessetforthinthisform, buttheymayonlyuseanddisclosetheinformationtotheotherpartiesonthislist,toyou oryourpersonalrepresentative,oraspermittedbylaw. Everyresearchsiteforthisstudy,includingtheMoffittCancerCenter,andincluding eachsitesresearchstaffandmedicalstaff EveryhealthcareproviderandothermemberoftheMoffittCancerCenterworkforce whoprovidesservicestoyouinconnectionwiththisstudy 3.Anylaboratoriesandotherindividualsandorganizationsthatuseyourhealth informationinconnectionwiththisstudyinaccordancewiththestudysprotocol 4.Anysponsorofthestudy,includingthefollowingresearchsponsors:None 5.TheUnitedStatesFoodandDrugAdministration,DepartmentofHealthandHuman Services(DHHS)andanyotherfederal,stateorlocalgovernmentalagencythat regulatestheresearchstudy 6.ThedesignatedresearchProtocolReviewandMonitoringCommitteesandrelated staffoftheMoffittCancerCenter 7.TheNationalCancerInstituteinevaluatingtheongoingresearchoftheMoffitt CancerCenterasaComprehensiveCancerCenter 8.ThemembersandstaffofanyInstitutionalReviewBoardthathasoversight responsibilityforthisstudy 9.ThemembersandstaffoftheMoffittCancerCentersaffiliatedPrivacyBoard 10.Membersofthestudyteam,includingthefollowingPrincipalInvestigator,coinvestigators,sub-investigatorsandotherslistedonyourresearchstudyInformed Consent 11.StudyCoordinators,ResearchNursesandDataManagersinvolvedintheresearch 12.MembersoftheMoffittCancerCentersClinicalTrialsOffice/ClinicalResearch Operations 13.ContractResearchOrganization

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93 Ap pendixC:(Continued) 14.DataSafetyMonitoringBoardandStaff Additionally,thefollowingperson(s),classesofperson(s),and/ororganization(s)(as describedbelow): T heentitiesandpersonslistedabovemayemployorpayvariousconsultantsand companiestohelpthemunderstand,analyzeandconductthisstudy.Allofthesepeople maynotbeknown now,butifyouwouldliketohavemorespecificinformationaboutthisatanytime duringthestudy,youmayaskthePrincipalInvestigatorandyourquestionswillbe answered. TheMoffittCancerCentercannotguaranteetheprivacyofyourinformation,orblock furtheruseordistribution,aftertheinformationhaslefttheMoffittCancerCenter.The sponsorofthisstudymayfurtherdiscloseyourinformation.Ifdisclosedbythesponsor oranyotherpersonorentity,theinformationmaynolongerbecoveredbythefederal privacyregulations. Whatinformationwillbeusedordisclosed? Bysigningbelow,youauthorizetheuse an ddisclosureofyourentireresearchrecordandanymedicalorotherrecordsheldbythe MoffittCancerCenter,including,butnotlimitedto,HIV/AIDS,mentalhealth,substance abuseorgeneticinformation,exceptforinformationthatyouexpresslyexcludebelow. Thepurposefortheusesanddisclosuresyouareauthorizingistoconducttheresearch projectexplainedtoyouduringtheinformedconsentprocessandtoensurethatthe informationrelatingtothatresearchisavailabletoallpartieswhomayneeditfor researchpurposes.!"Excludetheinformationexpresslylistedbelow(ifblank,thennoinformation excluded): S PECIFICUNDERSTANDINGS Bysigningthisresearchauthorizationform,youauthorizetheuseand/ordisclosureof yourprotectedhealthinformationdescribedabove.Yourinformationmayalsobeused asnecessaryforyourresearch-relatedtreatment,tocollectpaymentforyourresearchrelatedtreatment(whenapplicable),andtorunthebusinessoperationsoftheMoffitt CancerCenter.

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94 Ap pendixC:(Continued) Thisinformationmayberedisclosediftherecipient(s)describedonthisformisnot requiredbylawtoprotecttheprivacyoftheinformation. Youhavearighttorefusetosignthisauthorization.Whileyourhealthcareoutsidethe study,thepaymentforyourhealthcare,andyourhealthcarebenefitswillnotbeaffected ifyoudonotsignthisform,youwillnotbeabletoparticipateintheresearchdescribed inthisauthorizationandwillnotreceivetreatmentasastudyparticipantifyoudonot signthisform. Ifyousignthisauthorization,youwillhavetherighttorevokeitatanytime,exceptto theextentthattheMoffittCancerCenterhasalreadytakenactionbaseduponyour authorizationorneedstheinformationtocompleteanalysisandreportsofdataforthis research.Yourrevocationwillapplyprospectivelyonly.Alldatacollectedpriortoyour decisiontowithdrawyourauthorizationtousethedataforresearchpurposes-including documentationofyourdecisiontowithdraw-maystillbeusedbythePrincipal Investigatorandcannotberevoked.Ifmedicallynecessary,thePrincipalInvestigatoror studystaffmayfollow-upwithyou.Ifyouhavedecidedtowithdrawyourauthorization tousethedataforresearchpurposesthisfollow-upinformationcannotbeusedor disclosedforresearchunlessrequiredbylaw. Thisauthorizationwillneverexpireunlessanduntilyouexpresslyrevokeitinwriting. Torevokethisauthorization,pleasewritetoPaulJacobsen,Ph.D.attheMoffittCancer Center12902MagnoliaDr.Tampa,FL33612. Bysigningbelow,youacknowledgeyourreceiptofacopyofthisform. SIGNATURE Ihavereadthisformandallofmyquestionsaboutthisformhavebeenanswered.By signingbelow,IacknowledgethatIhavereadandacceptalloftheabove. _________________________________________ SignatureofSubjectorPersonalRepresentative _________________________________________ PrintNameofSubjectorPersonalRepresentative _________________________________________ Date _________________________________________ DescriptionofPersonalRepresentativesAuthority

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95 Ap pendixC:(Continued) CONTACTINFORMATION Thecontactinformationofthesubjectorpersonalrepresentativewhosignedthisform shouldbefilledinbelow. Address: ______________________________ ______________________________ ______________________________ ______________________________ Telephone: ___________________(daytime) ___________________(evening) EmailAddress(optional): ____________________________ THESUBJECTORHISORHERPERSONALREPRESENTATIVEMUSTBE PROVIDEDWITHACOPYOFTHISFORMAFTERITHASBEENSIGNED.

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96 A ppendixD:ResearchAuthorizationforJamesA.HaleyVeteransHospital DepartmentofVeteransAffairs AuthorizationforReleaseofProtectedHealthInformationforResearchPurposes TitleofStudy:Characteris ticsandCorrelatesofHotFlashesinMenwithProstate Cancer YouhavebeenaskedtobepartofaresearchstudyunderthedirectionofRaoulSalup, M.D.andhisresearchteam.Thepurposeofthisstudyistofindouthowthehotflashes associatedwithhormonaltherapyaffectthemood,energylevel,sleepquality,sexual functioning,anddailyactivitiesofpatientswithprostatecancer. Bysigningthisdocument,youwillauthorizetheVeteransHealthAdministration(VHA) toprovideRaoulSalup,M.D.andhisresearchteampermissiontouseanddisclosethe followinginformationaboutyou: Theinformationthatwillbereleasedincludesinformationregardingthefollowing conditions: Demographicinformation Medicaltreatmenthistory Theresearchteammayalsoneedtodisclosetheinformationtoothersaspartofthestudy process.Theothersmayincludetheinstitutionalreviewboard. Ifyoudonotsignthisauthorization,youwillnotparticipateinthestudy. Thisauthorizationtouseyourinformationwillexpireattheendoftheresearchstudy. Youcanrevokethisauthorization,inwriting,atanytime.Torevokeyourauthorization, youmustwritetotheReleaseofInformationOfficeatthisfacilityoryoucanaska memberoftheresearchteamtogiveyouaformtorevoketheauthorization.Your requestwillbevalidwhentheReleaseofInformationOfficereceivesit.Ifyourevoke thisauthorization,youwillnotbeabletocontinuetoparticipateinthestudy.Thiswill notaffectyourrightasaVHApatienttotreatmentorbenefitsoutsidethestudy. Ifyourevokethisauthorization,RaoulSalup,M.D.andhisresearchteamcancontinueto useinformationaboutyouthatwascollectedbeforereceiptoftherevocation.The researchteamwillnotcollectinformationaboutyouafteryourevoketheauthorization. TheVHAcomplieswiththerequirementsoftheHealthInsurancePortabilityand AccountabilityActof1996anditsprivacyregulationsandallotherapplicablelawsthat protectyourprivacy.Wewillprotectyourinformationaccordingtotheselaws.Despite

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97 Ap pendixD:(Continued) theseprotection,thereisapossibilitythatyourinformationcouldbeusedordisclosedin awaythatitwillnolongerbeprotected.OurNoticeofPrivacyPractices(aseparate document)providesmoreinformationonhowweprotectyourinformation.Ifyoudonot haveacopyoftheNotice,theresearchteamwillprovideonetoyou. Ihavereadthisauthorizationformandhavebeengiventheopportunitytoaskquestions. IfIhavequestionslater,IunderstandIcancontactRaoulSalup,M.D.Iwillbegivena signedcopyofthisauthorizationformformyrecords.Iauthorizetheuseofmy identifiableinformationasdescribedinthisform. __________________________________ SignatureofParticipantorPersonAuthorized ToSignforParticipant(Attachauthoritytosign, e.g.,PowerofAttorney) Theexecutionofthisformdoesnotauthorizethereleaseofinformationotherthanthatspecificallydescribed.The informationrequestedonthisformissolicitedunderTitle38,U.S.C.Theformauthorizesreleaseofinformationthat youspecifyinaccordancewiththeHealthInsurancePortabilityandAccountabilityAct,45CFRParts160and164,5 U.S.C.552a,and38U.S.C.5701and7332.Yourdisclosureofinformationrequestedonthisformisvoluntary. Howeveriftheinformation,includingSocialSecurityNumber(SSN)(theSSNwillbeusedtolocaterecordsfor release)isnotfurnishedcompletelyandaccurately,DepartmentofVeteransAffairswillbeunabletocomplywiththe request. ThePaperworkReductionActof1995requiresustonotifyyouthatthisinformationcollectionisinaccordancewith theclearancerequirementsofsection3507oftheAct.Wemaynotconductorsponsor,andyouarenotrequiredto respondto,acollectionofinformationunlessitdisplaysavalidOMBnumber.Weexpectthatthetimeexpendedbyall individualscompletingthisformwillaverage2minutes.Thisincludesthetimetoread theinstructions,gatherthe necessaryfactsandfillouttheform.Thepurposeofthisformistospecificallyoutlinethecircumstancesunderwhich wemaydisclosedata.

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98 Ap pendixE:GeneralBackgroundInformation 1.Today'sdate:##/##/##(month/day/year) 2. Birthdate:##/##/##(month/day/year) 3. Height:#(ft)##(in) 4.Weight:###(pounds) 5. Whichofthefollowingbestdescribesyourethnicbackground?#1Spanish/Hispanic/Latino#2NotSpanish/Hispanic/Latino 6.Whatisyourrace?(checkonebox)#1White/Caucasian#4AmericanIndian/AlaskaNative#2Black/AfricanAmerican#5Other:_____________________#3Asian/PacificIslander 7. Maritalstatus(checkonebox):#1Nevermarried#4Divorced#2Currentlymarried#5Widowed#3Separated 8.Currentlivingarrangement(checkonebox):$1Livealone$5Livewithroommatewho#2Livewithspouse/partner isnotpartner#3Livewithspouse/partnerandchildren#6Livewithparents#4Livewithchildren(nospouse/partner)#7Other(specify)__________ 9 .Howlongincurrentlivingarrangement(checkonebox):#1Lessthan1month#4Twoto5years#2Oneto6months#5Morethan5years#3Sevenmonthsto2years

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99 Ap pendixE:(Continued) 10.Levelofschoolcompleted(checkonebox):$1Lessthan7thgrade$5Partialcollegeorspecializedtraining$2JuniorHighSchool$6Collegeoruniversitygraduate (7th,8th,&9thgrade)$7Graduateprofessionaltraining$3Partialhighschool(graduatedegree) (10thor11thgrade)$4HighSchoolgraduate 11.Currentemploymentsituation(checkallthatapply):$1Fulltimeatjob$2Parttimeatjob$3Onleavewithpay$4Onleavewithoutpay$5Disabled$6Seekingwork$7Retired$8Homemaker$9Student 12. Whichcategorybestdescribesyourusualoccupation?Ifyouarenotcurrently employed,whichcategorybestdescribesyourLASTjob?(checkonenumber):$1.Professional(e.g.teachers/professors,nurses,lawyers,physicians,& engineers)$2.Manager/Administrator(e.g.,salesmanagers)$3.Clerical(e.g.,secretaries,clerksormailcarriers)$4.Sales(e.g.,salespersons,agents&brokers)$5.Service(e.g.,police,cooks,waitress,orhairdressers)$6.SkilledCrafts,Repairer(e.g.,carpenters)$7.EquipmentorVehicleOperator(e.g.,truckdrivers)$8.Laborer(e.g.,maintenancefactoryworkers)$9.Farmer(e.g.,owners,managers,operatorsortenants)$10.Memberofthemilitary$11.Homemaker(withnojoboutsidethehome)$12.Other(pleas edescribe)________________________________________

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100 Ap pendixE:(continued) 13.Whichcategorybestdescribesyourspousesusualoccupation?Ifyourspouseis notcurrentlyemployed,whichcategorybestdescribeshis/herLASTjob?(check onenumber)$1.Professional(e.g.,teachers/professors,nurses,lawyers,physicians,& engineers)$2.Manager/Administrator(e.g.,salesmanagers)$3.Clerical(e.g.,secretaries,clerksormailcarriers)$4.Sales(e.g.,salespersons,agents&brokers)$5.Service(e.g.,police,cooks,waitress,orhairdressers)$6.SkilledCrafts,Repairer(e.g.,carpenters)$7.EquipmentorVehicleOperator(e.g.,truckdrivers)$8.Laborer(e.g.,maintenancefactoryworkers)$9.Farmer(e.g.,owners,managers,operatorsortenants)$10.Memberofthemilitary$11.Homemaker(withnojoboutsidethehome)$12.Other(pleasedescribe)____________________________________ 14.Whatisyourapproximateannualgrossincome?(checkonenumber) (Rememberallinformationyouprovidewillremaincompletelyconfidential)$1Lessthan$10,000$4$40,000-$59,999$2$10,000-$19,999$5$60,000-$100,000$3$20,000-$39,999$6Greaterthan$100,000 15. Approximateannualgrossincomeforyourhousehold:(checkonenumber) (Rememberallinformationyouprovidewillremaincompletelyconfidential)$1Lessthan$10,000$4$40,000-$59,999$2$10,000-$19,999$5$60,000-$100,000$3$20,000-$39,999$6Greaterthan$100,000

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101 Ap pendixE:(Continued) 22.Whichofthefollowingbestdescribeshowyoupresentlyfunction?$1IamabletocarryonnormalactivityordoworkandIhavenophysical c omplaintsorproblems.$2Iamabletocarryonnormalactivityordoworkevenwithminorphysical c omplaints.$3Iamabletocarryonnormalactivityordoworkbutittakeseffortbecause o fphysicalproblems.$4IamunabletocarryonnormalactivitybutIcareformyself.$5IamunabletocarryonnormalactivityandIrequireoccasionalhelpfrom ot hers,butIamabletocareformostofmypersonalneeds.$6IrequireconsiderablehelpfromothersandIrequirefrequentmedical car e.$7IamdisabledandIrequirespecialcareandhelp.

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102 Ap pendixF:HotFlashQuestionnaire Pleaserespondtothefollowingquestionsinregardstothe pasttwoweeks .Ahotflashis ashort-livedepisodeofflushing,sweating,andasensationofheat.Itisoften accompaniedbyheartpalpitationsandafeelingofanxietyandmaysometimesbe followedbychills. 1.Haveyouexperiencedhotflashesinthe pasttwoweeks ?$yes$no(pleasegoontonextpage) 2.Approximatelyhowmanyhotflasheshaveyouexperiencedoverthe pasttwo weeks ?______ 3.Pleaseratetheseverityofyourhotflashesonaverageoverthe pasttwoweeks .$Mild$Moderate$Severe$Verysevere

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103 A ppendixG:HotFlash-RelatedDailyInterferenceScale PleasecheckoneboxtodescribehowmuchDURINGTHEPASTWEEKhotflashes haveINTERFEREDwitheachaspectofyourlife.Highernumbersindicatemore interferencewithyourlife.Ifyouarenotexperiencinghotflashesorifhotflashesdonot interferewiththeseaspectsofyourlife,pleasemarkzerototherightofeachquestion. Donot Complet ely interfere int erfere 012345678910 1.Work(outsidethehomeand housework) $$$$$$$$$$$ 2.Socialactivities(timespent withfamily,friends,etc.) $$$$$$$$$$$ 3.Leisureactivities(timespent relaxing,doinghobbies,etc.) $$$$$$$$$$$ 4.Sleep $$$$$$$$$$$ 5.Mood $$$$$$$$$$$ 6.Concentration $$$$$$$$$$$ 7.Relationswithothers $$$$$$$$$$$ 8.Sexuality $$$$$$$$$$$ 9.Enjoymentoflife $$$$$$$$$$$ 10.Overallqualityoflife $$$$$$$$$$$

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A ppendixH:FatigueSymptomInventory Foreachofthefollowing,checkoneboxnexttothenumberthatbestindicateshowthat itemappliestoyou. 1.Rateyourleveloffatigueonthedayyoufelt most fatiguedduringthepastweek: $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 Notatall Asfatigued fatigued asIcouldbe 2.Rateyourleveloffatigueonthedayyoufelt least fatiguedduringthepastweek: $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 Notatall Asfatigued fatigued asIcouldbe 3.Rateyourleveloffatigueonthe average duringthepastweek: $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 Notatall Asfatigued fatigue asIcouldbe 4.Rateyourleveloffatigue rightnow : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 Notatall Asfatigued fatigued asIcouldbe 5.Ratehowmuch,inthepastweek,fatigueinterferedwithyour generallevelof activity: $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 Notatall Asfatigued fatigued asIcouldbe 6.Ratehowmuch,inthepastweek,fatigueinterferedwithyour abilitytobatheand dressyourself : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 No Extreme interference interference

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105 Ap pendixH:(Continued) 7.Ratehowmuch,inthepastweek,fatigueinterferedwithyour normalworkactivity (includesbothworkoutsidethehomeandhousework) : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 No Extreme interference interference 8.Ratehowmuch,inthepastweek,fatigueinterferedwithyour abilitytoconcentrate : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 No Extreme interference interference 9.Ratehowmuch,inthepastweek,fatigueinterferedwithyour relationswithother people : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 No Extreme interference interference 10. Ratehowmuch,inthepastweek,fatigueinterferedwithyour enjoymentoflife : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 No Extreme interference interference 11.Ratehowmuch,inthepastweek,fatigueinterferedwithyour mood : $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 No Extreme interference interference 12.Indicate howmany days ,inthepastweek,youfeltfatiguedforanypartoftheday: $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 Days Days 13.Rate howmuchoftheday ,onaverage,youfeltfatiguedinthepastweek: $ 0 $ 1 $ 2 $ 3 $ 4 $ 5 $ 6 $ 7 $ 8 $ 9 $ 10 Noneof Theentire theday d ay

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106 Ap pendixH:(Continued) 14.Indicatewhichofthefollowingbestdescribesthe dailypattern ofyourfatigue inthepastweek: $ 0 $ 1 $ 2 $ 3 $ 4 NotatallWorseinWorseinWorseinNoconsistentdaily fatiguedthemorningtheafternoontheeveningpatternoffatigue

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107 Ap pendixI:PittsburghSleepQualityIndex Thefollowingquestionsrelatetoyourusualsleephabitsduringthepastweekonly .Your answersshouldindicatethemostaccuratereplyforthemajorityofdaysandnightsinthe pastweek.Pleaseanswerallquestions. 1.Duringthepastweek,whenhaveyouusuallygonetobedatnight? USUALBEDTIME____________ 2.Duringthepastweek,howlong(inminutes)hasitusuallytakenyoutofallasleep eachnight? NUMBEROFMINUTES______________ 3.Duringthepastweek,whenhaveyouusuallygottenupinthemorning? USUALGETTING UPTIME________________ 4.Duringthepastweek,howmanyhoursofactualsleepdidyougetanight?(This maybedifferentthanthenumberofhoursyouspendinbed.) HOURSOFSLEEPPERNIGHT_______________ Foreachoftheremainingquestions,checktheonebestresponse.Pleaseanswerall questions. 5.Duringthepastweek,howoftenhaveyouhadtroublesleepingbecauseyoucannot gettosleepwithin30minutes? Not Afew Several Everynightor atall_____(1-2)times_____(3-5)times_____almosteverynight_____ 6. Duringthepastweek,howwouldyourateyoursleepqualityoverall? Verygood_____Fairlygood______Fairlybad_______Verybad_______ 7.Duringthepastweek,howoftenhaveyoutakenmedicine(prescribedoroverthe counter)tohelpyousleep? Not Afew Several Everynightor atall_____(1-2)times_____(3-5)times_____almosteverynight_____

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108 A ppendixJ:CenterforEpidemiologicalStudies-DepressionScale Foreachstatementbelow,makean X intheboxwhichbestdescribeshowoftenyou feltorbehavedthisway-DURINGTHEPASTW EEK,INCLUDINGTODAY. DURINGTHEPASTWEEK: Noneof thetime Alittleof thetime Amoderate amountof thetime Allof the time 1.Iwasbotheredbythingsthatusually didntbotherme. $$$$ 2.Ididntfeellikeeating;myappetite waspoor. $$$$ 3.IfeltthatIcouldnotshakeoffthe bluesevenwithhelpfromfamilyor friends $$$$ 4.IfeltthatIwasjustasgoodasother people. $$$$ 5.Ihadtroublekeepingmymindon whatIwasdoing. $$$$ 6.Ifelt depre ssed... $$$$ 7.IfeltthateverythingIdidwasan effort. $$$$ 8.Ifelthopefulaboutthefuture $$$$ 9.Ithoughtmylifehadbeenafailure... $$$$ 10.Ifeltfearful.. $$$$ 11.Mysleepwasrestless.. $$$$ 12.Iwashappy... $$$$ 13.Italkedless thanusua l. ... $$$$ 14.Ifeltlonely.. $$$$ 15.Peoplewereunfriendly $$$$

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109 Ap pendixJ:(Continued) Noneof thetime Alittleof thetime Amoderate amountof thetime Allof the time 16.Ienjoyedlife $$$$ 17.Ihadcryingspells... $$$$ 18.Ifeltsad... $$$$ 19.Ifeltthatpeopledislikedme... $$$$ 20.Icouldnotgetgoing. $$$$

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110 A ppendixK:ImpactofEventsScale Belowisalistofcommentsmadebypeopleaboutstressfulevents.Foreachitem,putan XintheboxthatindicateshowfrequentlythesecommentsweretrueforyouDURING THEPASTWEEKINCLUDINGTODAYABOUTYOURCANCERANDITS TREATMENT .Iftheydidnotoccurduringthattime,pleasemarkthe"notatall" column. NotatallRarelySometimesOften 1.ThoughtaboutitwhenIdidn'tmeanto... 2.Iavoidedlettingmyselfgetupsetwhen Ithoughtaboutitorwasremindedofit.. 3.Itriedtoremoveitfrommemory 4.Ihadtroublefallingasleeporstaying asleep,becauseofpicturesorthoughts aboutitthatcameintomymind 5.Ihadwavesofstrongfeelingsaboutit.. 6.Ihaddreamsaboutit. 7.Istayedawayfromremindersofit 8.Ifeltasifitwasnotreal 9.Itriednottotalkaboutit... 10.Picturesaboutitpoppedintomymind. 11.Otherthingskeptmakingmethink aboutit. 12.IwasawarethatIhadalotoffeelings aboutit,butIdidn'tdealwiththem. 13.Itriednottothinkaboutit 11.Anyreminderbroughtbackfeelings aboutit. 15.Myfeelingsaboutitwerekindofnumb..

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111 Ap pendixK:(Continued) NotatallRarelySometimesOften 16.Iavoidedtalkingaboutcancer, evenifitwasonmymind. 17.Thoughtsaboutcancerpoppedinto mymind 18.Itriedtoavoidevensayingthe wordcancer

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112 Ap pendixL:BemSexRoleInventoryShortForm Listedbelow,youwillfindanumberofpersonalitycharacteristics.Usethose characteristicstodescribeyourself.Checktheboxcorrespondingtohowtrueeachof thesecharacteristicsis. Pleasedonotleaveanycharacteristicunmarked. Never or almost never true Usually not true Sometimes, but infrequently true Occasi onally true Often true Usually true Always or almost always true 1.Defendmy own beliefs $$$$$$$ 2.Affectionate $$$$$$$ 3.Conscientious $$$$$$$ 4.Independent $$$$$$$ 5.Sympathetic $$$$$$$ 6.Moody $$$$$$$ 7.Assertive $$$$$$$ 8.Sensitiveto needsof others.. $$$$$$$ 9.Reliable $$$$$$$ 10.Strong personality $$$$$$$ 11.Understanding 12.Jealous. $$$$$$$ 13.Forceful $$$$$$$ 14.Compassionate.. $$$$$$$

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113 Ap pendixL:(Continued) Never or almost never true Usually not true Sometimes, but infrequently true Occasi onally true Often true Usually true Always or almost always true 15.Truthful $$$$$$$ 16.Have leadership abilities. $$$$$$$ 17.Eagerto soothhurt feelings. $$$$$$$ 18.Secretive $$$$$$$ 19.Willingto takerisks $$$$$$$ 20.Warm $$$$$$$ 21.Adaptable $$$$$$$ 22.Dominant $$$$$$$ 23.Tender $$$$$$$ 24.Conceited $$$$$$$ 25.Willingto takeastand $$$$$$$ 26.Lovechildren $$$$$$$ 27.Tactful $$$$$$$ 28.Aggressive $$$$$$$ 29.Gentle $$$$$$$ 30.Conventional $$$$$$$

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114 A ppendixM:HotFlashCatastrophizingScale(Baseline) Instructions: Thefollowingstatementsdescribedifferentthoughtspeoplehavewhen t heyexperiencehotflashes. Ahotflashisashort-livedepisodeofflushing,sweating, andasensationofheat.Itisoftenaccompaniedbyheartpalpitationsandafeeling ofanxietyandmaysometimesbefollowedbychills. Foreachstatement,pleasecheck theboxthatindicates howyouimagineyoumightrespondifyouweretoexperiencehot flashes .Markonlyoneresponseforeachitemandtrytoanswereveryitem. One SomehalfMostAll oftheoftheoftheofthe Nevertimetimetimetime truetruetruetruetrue 1.IwouldfeellikeIjustwanted togetupandrunaway............. $$$$$ 2.Iwouldimaginethehotflashes becomingevenmoreintenseand exhausting........... $$$$$ 3.Iwouldbeginthinkingofallthepossible thingsthatcouldgowrongin associationwiththehotflashes........ $$$$$ 4.IwouldtellmyselfthatIdontthink Icouldbearthehotflashes... $$$$$ 5.Iwouldfindmyselfworryingabout possiblydying..................... $$$$$ 6.Iwouldexpecttheworst............. $$$$$ 7.Iwouldthinkthatmyhotflashes wereprettyawful.................. $$$$$ 8.Iwouldfindmyselfconcentrating onhowterriblethehotflashes actuallyfelt... $$$$$ 9.Iwouldfinditvirtuallyimpossible tokeepmymindoffmyhotflashes.... $$$$$ 10.Iwouldbegintoworrythatsomething mightbeseriouslywrongwithme....... $$$$$

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115 A ppendixN:HotFlashCatastrophizingScale(3MonthFollow-Up) Instructions: Thefollowingstatementsdescribedifferentthoughtspeoplehavewhen t heyexperiencehotflashes. Ifyouhaveexperiencedhotfl ashesinthepasttwoweeks, pleaserespondtotheitemsbelow.IfyouhaveNOTexperiencedhotflashes,you maygoontothenextpage. Foreachstatement,pleasechecktheboxthatindicates how youhavefeltinthepasttwoweeks. Markonlyoneresponseforeachitemandtryto answereveryitem. One SomehalfMostAll oftheoftheoftheofthe Nevertimetimetimetime truetruetruetruetrue 1.IfeltlikeIjustwanted togetupandrunaway............. $$$$$ 2.Iimaginethehotflashes becomingevenmoreintenseand exhausting........... $$$$$ 3.Ithinkofallthepossible thingsthatcouldgowrongin associationwiththehotflashes........ $$$$$ 4.ItellmyselfthatIcant bearthehotflashes... $$$$$ 5.Ifindmyselfworryingabout possiblydying..................... $$$$$ 6.Iexpecttheworst............ $$$$$ 7.Ithinkthatmyhotflashes areprettyawful.................. $$$$$ 8.Ifindmyselfconcentrating onhowterriblethehotflashes actuallyfeel... $$$$$ 9.Ifinditvirtuallyimpossible tokeepmymindoffmyhotflashes.... $$$$$ 10.Iworrythatsomethingmight beseriouslywrongwithme...... $$$$$

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116 A ppendixO:ExpandedProstateCancerIndexComposite ThisquestionnaireisdesignedtomeasureQualityofLifeinpatientswithProstatecancer. Tohelpusgetthemostaccuratemeasurement,itisimportantthatyouanswerall questionshonestlyandcompletely. Thissectionisaboutyoururinaryhabits.PleaseconsiderONLYTHELAST4WEEKS. 1.Overthe past4weeks ,howoftenhaveyouleakedurine?(Checkonlyonebox) $ Morethanonceaday $ Aboutonceaday $ Morethanonceaweek $ Aboutonceaweek $ Rarelyornever 2.Whichofthefollowingbestdescribesyoururinarycontrol duringthelast4 weeks ?(Checkonebox) $ Nourinarycontrolwhatsoever $ Frequentdribbling $ Occasionaldribbling $ Totalcontrol 3.Howmanypadsoradultdiapersperday didyouusuallyusetocontrolleakage d uringthelast4weeks ?(Checkonebox) $ None $ 1padperday $ 2padsperday $ 3ormorepadsperday 4.Howbigaproblem,ifany,haseachofthefollowingbeenforyou duringthelast 4weeks ?(Checkoneboxoneachline) NoVerysmallSmallModerateBig problemproblemproblemproblemproblem a.Drippingorleaking urine.. $$$$$ b.Painorburningon urination $$$$$ c.Bleedingwith urination $$$$$

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117 Ap pendixO:(Continued) NoVerysmallSmallModerateBig problemproblemproblemproblemproblem d.Weakurinestream Orincompleteemptying $$$$$ e.Wakinguptourinate $$$$$ f.Needtourinate frequentlyduringtheday... $$$$$ 5.Overall,howbigaproblemhasyoururinaryfunctionbeenforyouduringthelast4 weeks? $ Noproblem $ Verysmallproblem $ Smallproblem $ Moderateproblem $ Bigproblem ________________________________________________________________________ Thisnextsectionisaboutyourbowelhabitsandabdominalpain.Pleaseconsider ONLY THELAST4WEEKS. 6.Howbigaproblem,ifany,haseachofthefollowingbeenforyou?(checkoneboxon eachline) NoVerysmallSmallModerateBig problemproblemproblemproblemproblem a.Urgencytohavea bowelmovement.. $$$$$ b.Increasedfrequency ofbowelmovements $$$$$ c.Waterybowel movements.. $$$$$ d.Losingcontrolofyour stools. $$$$$ e.Bloodystools. $$$$$ f.Abdominal/pelvic/rectal pain.. $$$$$

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118 Ap pendixO:(Continued) 7.Overall,howbigaproblemhaveyourbowelhabitsbeenforyou duringthelast4 weeks ?(Checkonebox) $ Noproblem $ Verysmallproblem $ Smallproblem $ Moderateproblem $ Bigproblem ________________________________________________________________________ Thisnextsectionisaboutyour current sexualfunctionandsexualsatisfaction.Manyof thequestionsareverypersonal,buttheywillhelpusunderstandtheimportantissuesthat youfaceeveryday.Remember,THISSURVEYINFORMATIONISCOMPLETETLY CONFIDENTIAL .Pleaseanswerhonestlyabout THELAST4WEEKSONLY. 8.Howwouldyourateeachofthefollowing duringthelast4weeks ?(Checkonebox oneachline) Verypoor Very tononePoorFairGoodgood a.Yourlevelofsexualdesire? $$$$$ b.Yourabilitytohaveanerection $$$$$ c.Yourabilitytoreachorgasm(climax)? $$$$$ 9.HowwouldyoudescribetheusualQUALITYofyourerections duringthelast4 weeks ?(Checkonebox) $ Noneatall $ Notfirmenoughforanysexualactivity $ Firmenoughformasturbationandforeplayonly $ Firmenoughforintercourse 10.HowwouldyoudescribetheFREQUENCYofyourerections duringthelast4 weeks ?(Checkonebox) $ INEVERhadanerectionwhenIwantedone $ IhadanerectionLESSTHANHALFthetimeIwantedone $ IhadanerectionABOUTHALFthetimeIwantedone $ IhadanerectionMORETHANHALFthetimeIwantedone $ IhadenerectionWHENEVERIwantedone

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119 Ap pendixO:(Continued) 11.Howoftenhaveyouawakenedinthemorningornightwithanerection duringthe last4weeks ? $ Never $ Lessthanonceaweek $ Aboutonceaweek $ Severaltimesaweek $ Daily 12. Duringthelast4weeks ,howoftendidyouhaveany sexualactivity? $ Notatall $ Lessthanonceaweek $ Aboutonceaweek $ Severaltimesaweek $ Daily 13. Duringthelast4weeks ,howoftendidyouhavesexualintercourse? $ Notatall $ Lessthanonceaweek $ Aboutonceaweek $ Severaltimesaweek $ Daily 14.Overall,howwouldyourateyourabilitytofunctionsexually duringthelast4 weeks ?(Checkonebox) $ Verypoor $ Poor $ Fair $ Good $ Verygood 15.Howbigaproblem duringthelast4weeks ,ifany,haseachofthefollowingbeen foryou?(Checkoneboxoneachline) NoVerysmallSmallModerateBig problemproblemproblemproblemproblem a.Yourlevelof sexualdesire.. $$$$$ b.Yourabilitytohave anerection. $$$$$

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120 Ap pendixO(Continued) NoVerysmallSmallModerateBig problemproblemproblemproblemproblem c.Yourabilitytoreach orgasm.. $$$$$ 16.Overall,howbigaproblemhasyoursexualfunctionorlackofsexualfunctionbeen foryou duringthelast4weeks ?(Checkonebox) $ Noproblem $ Verysmallproblem $ SmallProblem $ Moderateproblem $ Bigproblem ________________________________________________________________________ Thisnextsectionisaboutyourhormonalfunction.Pleaseconsider ONLYTHELAST4 WEEKS. 17. Overthelast4weeks ,howoftenhaveyouexperiencedhotflashes?(Checkonebox) $ Morethanonceaday $ Aboutonceaday $ Morethanonceaweek $ Aboutonceaweek $ Rarelyornever 18.Howoftenhaveyouhadbreasttenderness duringthelast4weeks ?(Checkonebox) $ Morethanonceaday $ Aboutonceaday $ Morethanonceaweek $ Aboutonceaweek $ Rarelyornever 19. Duringthelast4weeks ,howoftenhaveyoufeltdepressed?(Checkonebox) $ Morethanonceaday $ Aboutonceaday $ Morethanonceaweek $ Aboutonceaweek $ Rarelyornever

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121 Ap pendixO:(Continued) 20. Duringthelast4weeks ,howoftenhaveyoufeltalackofenergy?(Checkonebox) $ Morethanonceaday $ Aboutonceaday $ Morethanonceaweek $ Aboutonceaweek $ Rarelyornever 21.Howmuchchangeinyourweighthaveyouexperienced duringthelast4weeks ,if any?(Checkonebox) $ Gained10poundsormore $ Gainedlessthan10pounds $ Nochangeinweight $ Lostlessthan10pounds $ Lost10poundsormore 22.Howbigaproblem, duringthelast4weeks ,ifany,haseachofthefollowingbeen foryou?(Checkoneboxoneachline) NoVerysmallSmallModerateBig problemproblemproblemproblemproblem a.Hotflashes $$$$$ b. b.Breasttenderness/ enlargement.. $$$$$ c.Lossofbodyhair.. $$$$$ d.Feelingdepressed. $$$$$ e.Lackofenergy. $$$$$ f.Changeinbodyweight $$$$$

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A bouttheAuthor ErinWintersgraduatedsummacumlaudewithaBachelorsdegreein PsychologyfromJamesMadisonUniversityin1999.Aftercompletingherundergraduate studies,shewentontocontinuehereducationintheClinicalPsychologyprogramatthe UniversityofSouthFlorida(USF).ShereceivedherMastersdegreefromUSFin2002 aftersuccessfullydefendingherthesisentitled,DevelopmentandValidationofthe Stress-RelatedGrowthQuestionnaireforPersonswithCancer.Inkeepingwithher interestinpsychosocialoncology,sheremainedactiveinseveralresearchprojects investigatingthepsychologicalimpactofvariousformsofcancertreatment.Shereceived herPh.D.inClinicalPsychologyfromUSFin2006andcontinuestoconductboth researchandclinicalworkinthefieldofhealthpsychologywiththeVABoston HealthcareSystem.