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The relationship between hot flashes and sleep quality in women being treated for breast cancer
h [electronic resource] /
by Carly Pabon.
[Tampa, Fla.] :
b University of South Florida,
Thesis (M.S.)--University of South Florida, 2005.
Includes bibliographical references.
Text (Electronic thesis) in PDF format.
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ABSTRACT: Hot flashes are one of the most bothersome symptoms experienced by women who have undergone breast cancer treatment-induced menopause. This vasomotor symptom has been hypothesized to be responsible for decreased sleep quality. This study further investigated the relationship between hot flashes and sleep quality in this population. The convenience sample consisted of 30 women being seen at an outpatient clinic in a comprehensive cancer center in southwest Florida. All participants were between the ages of 36-65, had a diagnosis of breast cancer and were currently taking a selective estrogen receptor modulator for at least six weeks. The participants completed the Hot Flash Diary, Hot Flash Questionnaire, Hot Flash Related Daily Interference Scale, Pittsburgh Sleep Quality Index and a demographic form. The mean sleep score of the sample was 9.33 (SD= 4.4).Global sleep scores above five are indicative of poor sleep quality, and global sleep scores of eight or more have been linked to cancer-related fatigue. Sleep was strongly correlated with hot flash distress (r = .754, p. = .000) and hot flash severity (r = .718, p. = .000) and moderately correlated with hot flash interference (r = .507, p. = .004) and hot flash frequency while asleep (r = .680, p. = .000). The small sample size was a study limitation. However, study results do support findings from previous studies. This study addresses a symptom management problem that may give nurses better understanding of the experiences of their patients. These findings also may assist patients in helping their providers to understand the frustration they are experiencing with regard to their decreased sleep quality.
Adviser: Susan McMillan.
Selective estrogen receptor modulator.
t USF Electronic Theses and Dissertations.
The Relationship between Hot Flashes and Sl eep Quality in Women Being Treated for Breast Cancer by Carly Pabon, RN, BSN A thesis submitted in partial fulfillment of the requirements for the degree of Master of Science College of Nursing University of South Florida Major Professor: Susan McMillan, Ph.D., ARNP Janine Overcash Ph.D., ARNP Cecile Lengacher Ph.D., RN Date of Approval: November 9, 2005 Keywords: breast neoplasm, insomnia, tamoxife n, vasomotor, selective estrogen receptor modulator Copyright 2005, Carly Pabon
Dedication This is dedicated to my wonderful husband Eddie, my sister Beth, my mother and father, my grandmothers and my friends. Eddi e, this is for our family and our peanut. You never let me lose sight of what I re ally think is importa nt. You understood the sacrifices that needed to be made for this and made me feel that it was worth it. You are more than anyone could ever hope for. You ma ke me the luckiest girl in the world. To Bethythank you for stepping in as the big si ster and taking care of me. The Starbucks, the dinners and even a place to nap never went unnoticed. You are one of the most selfless people I know, I hope to earn a pl ace in your dedication one day! For my mom who started my hot flash interest and pretended to understand and be interested when I needed you to. I appreciate the gentle pus hing that gave me the foundation that I needed to eventually become a good student. I hope I make you proud. To Nana for all of your Mazel Tovs even if you really didn t know why I was so excited. I know you are always on my side. To Dad and Nanny for checking up on me and supporting all of my decisions. Lastly, to my classmates and friends Cindy and Nataliewe did it!! You understood when no one else could and made th e journey worth it, our friendship is the best thing to come out of this. The words on this page cannot fully express the gratitude I have for each of you for helping me to achieve this goal. Y ou are so special to me. I love you all.
Acknowledgements I would like to thank Dr. Janine Overcash and Dr. Cecile Lengacher for their kind criticism and sincere interest in my little paper. Thank you to Dr. Janet Carpenter for being the hot flash queen and entertaining al l of my questions a nd panicky e-mail. You have been a wonderful role model. Thank you Melissa Leggatt for your patience and willingness to assist me with my data. I woul d also like to thank all of the patients who were participants in this study. The braver y of cancer patients has always amazed me, you set that standard, I will be forever grateful for the impact you have had in my life. I also wanted to express my appreciation to all of my colleagues at Moffitt who are an extraordinary group of people. Lastly, I want to thank Dr. Susan McMillan, you always made me feel important to you. Thank you fo r making me put my faith in you, it did pay off!! I am proud to be one of yours.
i Table of Contents List of Tables iii Abstract iv Chapter One: Introduction 1 Problem Statement 2 Research Purpose 3 Research Questions 3 Definitions of Terms 3 Significance of the Problem 4 Chapter Two: Review of Literature 5 Model of Symptom Management 5 Review of Empirical Literature Hot Flashes and Breast Cancer 6 Sleep and Cancer 11 Hot Flashes and Sleep in the Breast Cancer Survivor 12 Summary 15 Chapter Three: Methods 16 Sample 16 Instruments Hot Flash Diary 17 Hot Flash Related Daily Interference Scale 18 Pittsburgh Sleep Quality Index 18 Demographic and Disease Treatment Information 19 Procedures 19 Data Analysis 20 Chapter Four: Results, Discussion and Conclusions 21 Results 21 Demographic Data 21 Sleep Quality 22 Hot Flash Frequency 23 Hot Flash Severity 23 Hot Flash Distress 24 Hot Flash Interference 24 Discussion 25 Demographic Data 25 Sleep Quality 26
ii Hot Flash Frequency 26 Hot Flash Severity 27 Hot Flash Distress 27 Hot Flash Interference 27 Conclusions 28 Recommendations for Future Research 28 References 29 Appendices 32 Appendix A: Hot Flash Diary 33 Appendix B: Hot Flash Severity Definitions 34 Appendix C: Hot Flash Relate d Daily Interference Scale 35 Appendix D: Pittsburgh Sleep Quality Index 36 Appendix E: Demographic Questionnaire 38 Appendix F: Disease and Treatment Information 39 Appendix G: Informed Consent 40 Appendix H: HIPPA Form 43
iii List of Tables Table 1 Frequency and Percent of Wo men by Ethnicity and Stage of Disease 21 Table 2 Frequency and Percent of Women by Medical Variables 22 Table 3 Correlations between Global Sl eep Scores and Hot Flash Experiences 23 Table 4 Number and Frequenc y of Hot Flashes experienced by the Severity Score 24
iv The Relationship between Hot Flashes and Sleep Quality in Women Being Treated for Breast Cancer Carly Pabon ABSTRACT Hot flashes are one of the most bothersom e symptoms experienced by women who have undergone breast cancer treatmen t-induced menopause. This vasomotor symptom has been hypothesized to be responsible fo r decreased sleep quality. This study further investigated the relationship between hot flashes and sleep quality in this population. The convenience sample consisted of 30 women being seen at an outpatient clinic in a comprehensive cancer center in southwest Florida. All participants were between the ages of 3665, had a diagnosis of breast cancer and were currently taking a selec tive estrogen receptor modulator for at least six week s. The participants completed the Hot Flash Diary, Hot Flash Questionnaire, Hot Flash Related Daily Interference Scal e, Pittsburgh Sleep Quality Index and a demographic form. The mean sleep score of the sample was 9.33 (SD= 4.4). Global sleep scores above five are indicative of poor sleep quality, and global sleep scores of eight or more have been linked to cancer-related fatigue. Sleep was strongly correl ated with hot flash distress (r = .754, p. = .000) and hot flash severity (r = .718, p. = .000) and mode rately correlated with hot flash interference (r = .507, p. = .004) and hot flash freque ncy while asleep (r = .680, p. = .000). The small sample size was a study limitati on. However, study results do support findings from previous studies. This study addresses a symptom management problem that may give nurses better understanding of the experiences of their patients. These findings also may assist
v patients in helping their providers to understand the frustration they are experienci ng with regard to their decreased sleep quality.
1 Chapter One Introduction Hot flashes are among the most comm on symptoms in women experiencing menopause. After breast cancer treatment-i nduced menopause, about 65% of women will have sudden episodes of intense warmth, whic h may begin in the chest and progress to the neck and face. Hot flashes may be accompanied by other bothersome symptoms such as anxiety, palpitations, prof use sweating, and red blotching of the skin (Finck, Barton, Loprinzi, Quella &, Sloan, 1998; Shanaf elt, Barton, Adjei &, Loprinzi, 2002). The concept of a decrease in sleep quality (waking episodes) in postmenopausal women with hot flashes has been accepted si nce 1981 (Erlik et al., 1981 ). However, it is only in the past 10 years that this topic has been investigated further to benefit the women experiencing this symptom distress. Women who are severely bothe red by hot flashes may be placed on estrogen therapy, which has b een shown to be the most effective choice to eliminate hot flashes in postmenopausal women (Carpenter et al., 1998; Jacobson et al., 2001). However, women with breast can cer are not given th is option; because estrogen has been contraindicated for this population (Carpenter et al., 1998). Other pharmaceuticals and alternative therapies used to treat hot flashes, such as black cohosh, venlafaxine, clonidine, and gaba pentin are currently under investigation (Carpenter et al., 1998; Jacobson et al., 2001; Loprinzi et al., 2000; Shanafelt, Barton, Adjei &, Loprinzi, 2002).
2 Decreased sleep quality can be related to many different physiological responses, and is often perceived by health care professionals as a symptom caused by anxiety or depression, which are both common in the cancer population (Carpenter, Elam, Ridner, Carney, Cherry & Cucullu, 2004). A review of th e literature by Savard and Morin (2001) concluded that between 30% and 50% of r ecently treated cancer patients reported sleep problems. This problem has not been adequa tely addressed in br east cancer survivors experiencing hot flashes. Problem Statement Women who go through menopaus e naturally are expected to have hot flashes and sleep disturbances. It has been hypothesi zed that women who undergo breast cancer treatment with tamoxifen (a selective estrogen receptor m odulator or SERM) experience decreased sleep quality and increased hot fl ash experience (including hot flash frequency, severity, and distress) compared to their healthy counterparts (Car penter & Andrykowski, 1999). In a study examining the circadian rh ythm of postmenopausal breast cancer survivors, hot flashes were experienced up to seven times a night. Twenty-one percent of all hot flashes experienced by these wome n occurred between 11 p.m. and 6 a.m. (Carpenter, Gautam, Freedman &, Andrykowsk i, 2001). This increase in hot flashes during sleeping hours commonly di srupts the womans sleep. However, it is not presently clear what characteristics of the hot flas h experience are related to decreased sleep quality.
3 Research Purpose The purpose of this study is to evaluate the relationships between the hot flash experience and sleep quality in breast cancer patients who are taking a selective estrogen receptor modulator. Research Questions The following research questions were addressed in this study. For breast cancer survivors taking a selective estrogen receptor modulator, including tamoxifen, toremifene and raloxifene: 1. Is there a relationship between hot flash frequency and sleep quality? 2. Is there a relationship between hot flash severity and sleep quality? 3. Is there a relationship between hot flash distress and sleep quality? 4. Is there a relationship between hot flash interference and sleep quality? Definitions of Terms The following terms are defined for the purposes of this study: Hot Flash Experience: The full spectrum of a hot flash experience, including the distress, frequency, interference, and seve rity perceived by the patient (Carpenter, Johnson, Wagner, & Andrykowski 2002). Hot Flash Frequency: Number of hot flashes in 24-hour period (Carpenter, Johnson, Wagner, & Andrykowski, 2002). Hot Flash Distress: The extent to which hot flas hes are bothersome (Carpenter, Johnson, Wagner, & Andrykowski, 2002). Hot Flash Interference: The degree hot flashes in terfere with daily living (Carpenter, 2001).
4 Hot Flash Severity: The intensity of the hot flas h physiological experience (Finck, Barton, Loprinzi, Quella &, Sloan, 1998). Sleep Quality: Includes quantitative aspects of sleep, such as sleep duration, sleep latency, or number of arousals, as we ll as more purely subjective aspects(Buysse, Reynolds, Monk, Berman &, Kupfer, 1989, p. 194). Significance of the Problem Women who experience SERM induced menopause endure a different hot flash and sleep quality disturbance than those in natural menopause. The sleep pattern disturbances of breast cancer survivors are currently clustere d with anxiety and depression without investigation into the im pact of the womans hot flashes. This inadequacy presents as missed assessments of the true etiology of the breast cancer survivors poor sleep quality. Understanding the relationship between sleep quality and hot flash severity, frequency, distress and sleep interference is necessary to provide evidence based nursing care. However, curr ent knowledge does not provide adequate information for nurses to fully explore sleep quality in the breast cancer survivor in a meaningful way. This research may add to the body of nursing knowledge from which nursing assessments, teaching, interven tions and research are derived.
5 Chapter Two Review of Literature It was first hypothesized in a study by Erlik et al. (1981) that hot flashes affected sleep. Since that time there have been coun tless research studies on both hot flashes and sleep. First, the conceptual framework will be discussed. This will be followed by a review of literature that focuses on menopa usal symptoms and hot flashes in breast cancer patients. Then, literature is presente d examining sleep in these patients and the impact that it has on the quali ty of life of those being studi ed. Finally a synthesis of the two topics, hot flashes and sleep in th e breast cancer survivor is reviewed. Model of Symptom Management The framework for this study is the M odel of Symptom Management created by the University of California, San Francisco School of Nursing (Larson et al., 1994). This framework focuses on the subjec tive view of the patient for gathering data and symptom management. This model focuses on three interrelated components: Symptom experience, symptom management st rategies, and symptom outcomes. This model exemplifies a comprehensive approach to symptom management, focusing on the three components and the integration to form the best possible strategy for care. The first dimension of the mode l of symptom management is the symptom experience, which contains the patients perception of his or her symptoms, the evaluation of those symptoms, and the patient s response to those symptoms. In this case
6 the symptom experience would be that of the hot flash experience and of sleep disturbance (Larson et al., 1994). This is the dimension of this framework that was the focus of this study. The second dimension is symptom manageme nt strategies. This is the symptoms treatment that has been found acceptable for the patient, the family and the healthcare provider. These strategies may be aimed at one or more components of the symptom experience. This is what can be perceived as the goal in most of the research discussed here. The research is designed with the thought that better unders tanding of the first dimension may help us to improve this second dimension. The third and last dimension of the Symptom Management Model is symptom outcomes. These have been conceptualized as 10 multidimensional indicators including: symptom status, financial status, self care ability, quality of life, morbidity and comorbidity, mortality, health service utiliza tion, functional status, and emotional status. Symptom status is central and influences th e other indicators, and hot flashes and sleep heavily influence this dimension. That can be determined by examining this dimension. Review of Empirical Literature Hot Flashes and Breast Cancer The purpose of the cross sectional descriptive study by McPhail and Smith (2000) was to evaluate the menopausal symptom e xperience in both women who were receiving adjuvant chemotherapy for treatment of breast cancer and wome n who were without breast cancer. Four hundred quest ionnaires were sent out to participants in the two groups, obtained from either a cancer center in Scotland where the women were receiving adjuvant chemotherapy or a breast screening service where the women had no cancer
7 diagnosis. One hundred and thirty-nine breast ca ncer patients returned the questionnaires, while 99 of the healthy women returned questionnaires. The instrument in the questionnaire was newly developed for this st udy and consisted of three sections: general health and menstrual history; questions a bout patients breast can cer diagnosis, cancer treatment and symptoms (not included for the healthy wome n); and questions to assess menopausal history and symptoms. Excluded from this study were those who had recurrent or metastatic disease, those over 65 years of age, those with a history of a comorbid disease process, and those who were unable to complete the packet independently. The study (McPhail & Smith, 2000) revealed four symptoms signi ficant to breast cancer patients compared with their healthy counterparts: increased tiredness (higher in those receiving chemotherapy p = 0.016); increa sed hot flashes (more frequent in those taking tamoxifen p = 0.002); and an increase in night sweats (p = 0.04). Healthy counterparts reported an increa sed frequency of headaches compared to the breast cancer patients (p = 0.025). These investigators concluded that hot flashes were the second most common symptom of breast can cer survivors and that this symptom was significantly worse for breast cancer patie nts than for healthy women. Carpenter and Andrykowski (1999) conduc ted telephone inte rviews of postmenopausal breast cancer survivors who were at least three months post-treatment (n = 114) to identify the most commonly reporte d menopausal symptoms. Menopausal status and symptoms were assessed using questions adapted from the Massachusetts Womens Health Study and an adapted version of th e Blatt Menopausal Index and Severity Index, respectively. Quality of life was assessed using the SF-12 Health Survey. Seventy-five
8 percent or more of the sample reported joint pain, feeling tired, trouble sleeping, and hot flashes/night sweats. Fifty-nine percent of those reporting hot flashes ranked them as being quite a bit or extremely severe. Sleep disturbance was reported in 77% of the study population, with 43% of these calling the severity quite a bit or extreme. A higher prevalence and severity of these symptoms wa s correlated with lower physical (r = -0.36) and emotional (r = -0.44) quality of life. Carpenter et al. (1998) conducted a study of the prevalence and severity of hot flashes and associated variables. The study also examined the knowledge of the breast cancer survivors on hot flash treatment and th e relationship between the hot flashes and quality of life. The women were no longer receiving treatment for breast cancer, with the exception of tamoxifen. Participants were sent a questionnaire packet to complete while on the phone with study personnel. The pack et included demographic questions, and questions that were adapted from the Mass achusetts Womens Health Study regarding menopausal status. Also included were instru ments assessing current and past hot flash management and a quality of life survey. Hot flashes were reported in 65% of pos tmenopausal women with breast cancer and 72% of women taking tamoxifen. These anal yses showed that women more likely to have severe hot flashes were typically gr eater in body mass index (p < 0.05), younger at diagnosis (p < 0.01), had received chemothera py (p < 0.05) and were users of tamoxifen (p < 0.01). Women with hot flashes reported a lower quality of life (p < 0.10). Study limitations included a small sample and one ge ographic area. Also, hot flash information was limited to prevalence, severity and sy mptom bother. The data would be more
9 informative if compared to a group of menopa usal women without breast cancer, as well as inclusion of daily frequency, daily patte rn, and intensity (Carpenter et al., 1998). A study conducted by Carpenter, Johnson, Wagner, and Andrykowski (2002) compared the severity of hot flashes in breast cancer survivors with healthy women going through menopause. Breast cancer survivors (n = 67) were age-matched (within 2 years) to healthy menopausal subjects. The breast cancer group had a first time diagnosis of breast cancer, no other cancer diagnosis, was disease free at the time of enrollment, three months past any treatment (including chemot herapy, radiation therapy or surgery) with the exception of tamoxifen (which they needed to be on for six weeks prior to the start of the study), and less than or equal to six years after dia gnosis. The healthy women had no history of cancer, and an inta ct uterus and ovaries. A pack et was sent to each woman describing the study and containing several in struments: a demographic, disease and treatment form, and gynecologic and reproductiv e history form for menopausal status; questions from the Massachusetts Women s Health Study to determine menopausal status; Profile of Mood States Short Form; Positive and Negative Affect Scale; Hot Flash-Related Daily Interference Scale; a nd a hot flash questionna ire. The hot flash questionnaire items included severity, bother, quality, aggravating factors, alleviating factors, and temporal patter n. A 48-hour detailed hot flash diary also was included for completion. The 48-hour hot flash diary is cons idered the gold standa rd of subjective hot flash frequency and severity measurement (B arton et al., 1998; Ca rpenter et al., 1998). Results were that breast cancer survivors have more frequent (p = 0.006), more severe (p = 0.001), more bothersome (p = 0.001) and longer (p = 0.002) hot flashes than their healthy counterparts. Findings also suggest that if women continue to have hot flashes,
10 they are more prone to negative psychosocial effects (p < 0.005). Th erefore, alleviating hot flashes may improve overall quality of life, including mood, affect, sleep, concentration, and sexuality. Quality of life is a focus of cancer patient care. Stein, Jacobsen, Hann, Greenberg and, Lyman, in 2000, focused on the impact of hot flashes on quality of life. This study examined 70 postmenopausal women with breast cancer who were over 18, receiving adjuvant chemotherapy or ra diotherapy, without unstable me dical problems or neurologic disorders, and without history of other cance rs. Using nine different measurements, the impact of hot flashes on their quality of life was determined. All of the data was collected 4-6 weeks after the start of therapy. Of the 70 women in the study, 42 were receiving radiation therapy, and 28 chemotherapy, 6 we re also taking tamoxifen. The measures used in the study included, a demographic data form, the SF-36 health survey, Memorial Symptom Assessment Scale, State-Trait Anxi ety Inventory, Center for Epidemiological Studies Depression Scale, Profile of Mood States Fatigue Scale, Fatigue Symptom Inventory, Multidimensional Fatigue Sympto m Inventory, and the Pittsburgh Sleep Quality Index. Forty percent of the 70 women in the study by Stein et al. (2000) were having hot flashes. Sixty-seven percent stat ed that they were moderate to severe, and 58% stated that they were somewhat to very much distressed by the symptom. Compared to the women in the study who did not report having hot flas hes, the women with hot flashes were 66% more fatigued, 63% had poorer sleep qua lity, and 20% had poorer health.
11 Sleep and Cancer Engstrom, Strohl, Rose, Lewandowski a nd, Stefanek (1999) conducted a study on sleep disturbances in patients with cancer A convenience sample of lung cancer (n=57) and breast cancer (n=93) patients was studied. Inclusion criteria incl uded that the patient had to have received (67%) or be curr ently (33%) receiving either chemotherapy, hormone therapy, radiation therapy, surgery, or was considered to be receiving supportive care only. An 82-item detailed questionna ire was administered over the phone. The results of the study found no relationshi p between sleep disturbances and day naps, pain or nausea, diagnosis, stage of diseas e, or treatment. Fortyfour percent reported sleep disturbances occurring within one month of the assessment. Only 16.6% of those patients reported sleep problems to a nurse or doctor. When asked why they did not report sleep symptoms one patient stated, I t hought it was not as important as having the cancer itself (Engstrom et al., 1999, p. 149). Fortner, Stepanski, Wang, Kasprowi cz and Durrence (2002) conducted a cross sectional survey of breast cancer and medical pa tients to investigate the characteristics of their sleep. Seventy-two breast cancer patien ts and 50 healthy women were given the Pittsburgh Sleep Quality Index and Rand 36 ite m Health Survey. Of the 72 breast cancer patients, 19 were pre-cancer treatment, 29 were receiving treatment and 23 had received treatment in the past. Sixty-one percent of the breast cancer patients had a significant decrease in sleep quality. This was attributed to several things. The most frequent reason for sleep disturbance was reported to be the need to use the bathroom, followed by feeling too hot, middle of the night or ear ly awakening, and coughing or sneezing loudly. The only reported difference between the he althy group and breast cancer group was the
12 use of medication to facilita te sleep, with breast cancer patients more likely to use medications than their healthy counterparts. There was also a decreased amount of total sleep time of the breast cancer grou p compared to the healthy group. Kravitz et al. (2003) created a large study depicting the differences in sleep in midlife women when considering ethnicity a nd the different stages of menopause. There were 12,603 participants in this study, all of whom were be tween 40 and 55 years of age. Ethnicity was defined as either African Am erican, Caucasian, Chinese, Japanese or Hispanic. Menopausal status was defined as premenopausal, early perimenopausal, late perimenopausal, naturally postmenopaus al, surgically postmenopausal, or postmenopausal on hormone replacement thera py. Subjects were all requested to take a 12-item symptom questionnaire regarding sleep and a demographic form, which helped to determine stage of menopause. The women who were the least likely to have sleep difficulties were premenopausal and Japanese The women most likely to have sleep difficulties were Caucasian, had higher educ ation, vasomotor symptoms (hot flashes), psychologic symptoms, increased perceived stress, poorer self perceived health, decreased quality of life, decreased physical activity, current smokers and a diagnosis of arthritis. Forty percent of Caucasian wome n, 38% of Hispanic women, 35% of African American women, 31% of Chinese women, and 28% of Japanese women reported sleep difficulty. Late perimenopausal women were the most common me nopausal status group to have sleep difficulty. Hot flashes and Sleep in the Breast Cancer Survivor It is important to understa nd the potential for sleep disruptions in women who are breast cancer survivors because this is what will fuel the treatments of the future.
13 Carpenter, Gautam, Freedman and Andrykowsk i (2001) took on the in vestigation of the circadian rhythm of objectivel y recorded hot flashes in this population. Twenty-one women were connected to a sternal skin conductance monitor for 24 hours to record hot flash activity. These women all had a firs t time diagnosis of breast cancer, were postmenopausal, 3 months post diagnosis, were currently disease free, and currently having hot flashes but not taking medication to treat them. The women, in addition to being connected to a monitor for 24 hours, were asked to keep an activity diary keeping track of activities, including exercise, work, driving, bed time and sleep time and perceived hot flashes. The findings from this study suggest that the circadian rhythm is disrupted among breast cancer survivors. Tw enty-one percent of hot flashes were between 11 p.m. and 6 a.m. and half the samp le had at least three and up to seven hot flashes during sleep. This significant number of hot flashes during sleep hours leads to fatigue, poor sleep quality and sleep disturbances (Carpenter et al., 2004). The limitations of this study were suggested to be a sma ll sample size, only a 24 hour recording period and lack of a control group. Carpenter et al., (2004) compared hot fl ashes, sleep quality and disturbance, fatigue and depressive sympto ms between breast cancer surv ivors (n = 46) and healthy women. Criteria for breast cancer was ol der than 21, English speaking, peri or postmenopausal, experiencing daily hot flashe s, in good general health, not depressed, not taking hot flash treatment, first diagnosis of cancer, disease free at time of study enrollment, at least 4 weeks post cancer treatm ent and, if applicable, on tamoxifen for at least 6 weeks. These women were matched to healthy women. The subjects were given a demographic form, the Pittsburgh Sleep Quality Index, the Profile of Mood States Short
14 Form, and Center for Epidemiological Studi es-Depression Scale, and were monitored with a sternal skin conductance monitor to assess hot flashes. The monitor was placed on the subject for two 24-hour periods spaced one week apart. The women were also asked to complete a hot flash diary to assist in interpreting the data from the monitor. The results of the study were that both groups reported similar sleep quality, though breast cancer survivors experienced more nighttime hot flashes than th e healthy women did. Both samples were found to have had a sy mptom cluster of poor sleep, fatigue and depression, possibly related to menopausal status (Carpent er et al., 2004). The last study in this review seems to c onnect the rest of the studies that were reviewed. This study by Savard et al. (2004) assessed the relationship between objectively measured nighttime hot flashes and objectively measured sleep quality. Participants were breast cancer survivors (n = 24) with a diagnos is of insomnia as dictated by the International Classificati on of Sleep Disorders and Diagnostic and Statistical Manual of Mental Disorders IV (American Psyc hiatric Association, 1994). The measures used in this study included an Insomnia Interview Schedule, a medication record, and the Hot Flash item of the Europ ean Organization for Research and Treatment of Cancer and the Breast Ca ncer Specific Quality of Life Questionnaire. A skin conductance monitor objectively measured the hot flashes. Sleep was objectively measured by polysomnography, includi ng electroencephalograph (EEG), electromyography (EMG), and electrooculograp h (EOG) recordings. Several variables were measured with these instruments, includ ing: time in bed, total wake time, total sleep time, percentage of time in each stage of sleep, percentage of time awake, number and duration of brief arousals, number of awakenings, sleep efficiency, latency time in each
15 stage of sleep, and number of changes from a higher level of sleep to a lesser level of sleep. Each woman was studied th ree nights in the sleep lab, with data from only the last two nights included in the data analysis to avoid a threat to external validity. The data collected revealed that hot fl ashes could be associated with sleep disruption in breast cancer survi vors. There was an increase in the frequency of the hot flashes between 3 a.m. to 5 a.m. and 11 p.m. to 12 a.m. with an increase in wake time and higher number of stage changes to lighter sleep 10 minutes before or after the hot flash was experienced. A limitation to the study was th at when a hot flash was detected there was a 20-minute window where a new hot flash could not be identified (Savard et al., 2004). The subject is more likely to be aw ake making them unlikely to wake up again. This may account for the lack of difference between the number of awakenings between hot flash time and non hot flash time. This shoul d be considered a limitation of this study. Summary The studies reviewed have suggested that there is a rela tionship between hot flashes and sleep quality. It is clear that there is a difference between women who are survivors of breast cancer who take tamoxife n and those who have never had the disease in their menopausal experience. No studies we re found that have subjectively evaluated the relationship between each aspect of the hot flash sy mptom experience and sleep quality.
16 Chapter Three Methods This chapter presents the study design and methods. The purpose of this study is to evaluate the relationships between the hot flash experience and sleep quality in breast cancer patients who are taking a selective estrogen receptor modulator. The relationship between hot flashes and sleep quality was eval uated using quantitative research with a non-experimental correlational design. It was anticipated th at breast cancer survivors who have increased hot flash severity, distre ss, frequency, and interference would have decreased sleep quality. Sample The setting for this study was an outpatie nt breast clinic in a comprehensive cancer center in Southwest Florida. Women e ligible to participate in the study had to meet the following criteria: 1) a diagnosis of breast cancer, 2) currently taking a SERM, either tamoxifen, toreifene, or raloxifene for at least six weeks, 3) be over age 18, 4) able to read, write, and understand English, and 5) able to provide informed consent. Exclusion criteria included a di agnosis of any other type of cancer, and treatment of any cancer including radiation therapy, chemothera py or surgery in the past six months to avoid their confounding effects. A conveni ence sample of 88 women who had been diagnosed with breast cancer and were currently taking a SERM was sought. Using variables at an interval level of data, a Pearson's r was planned to describe the
17 relationship between two variables. With al pha at .05, two-tailed, a population correlation coefficient of .30 for a moderate effect size, and a power of .80, the sample size needed for this study was 88. Instruments The researcher reviewed four self-repor t measures with the participants. One measure was gathered from the medical record by the researcher. Hot Flash Diary The Hot Flash Diary (Appendix A) is a brie f questionnaire that was used to assess patient perceptions regarding hot flash frequency, hot flash dist ress and hot flash severity. This included definitions (Appendix B) that assisted the woman to place each of her hot flashes in one of the four severity categories ranging from mild to ve ry severe (Sloan et al., 2001). The number of hot flashes the woma n has experienced in the past 24 hours and during her sleep was assessed w ith this instrument as well. Women were also asked to provide an overall rating of how bothered th ey are by their hot flashes using a 10-point numeric scale 0 (not at all) to 10 (extremely). This type of diary has been used previously and is considered the gold standard for assess ing hot flash frequency and severity subjectively (Barton et al., 1998; Sloa n et al., 2001). This Diary has been used to assess hot flashes at present as well as hot flashes over an extended period of time. In this study the Hot Flash Diary was used as a four-question twenty-four hour recall. Validity and reliability has been reported by Sloan et al., (2001) who states that the Hot Flash Diary has concurrent and discriminant validity and reliability from the study of a placebo controlled trial.
18 Hot Flash Related Daily Interference Scale The Hot Flash Related Daily Interfer ence Scale (HFRDIS) developed by Carpenter (2001) is a 10-item scale measuring the degree hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life (Appendix C). The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Particip ants rate the degree to which hot flashes have interfered with each item during the previ ous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing these items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life. Women without hot flashes are asked to si mply mark 0 for each item. Internal consistency reliability was estimated with a Cronbach alpha coefficient and reported to be 0.96. Validity was supported thro ugh 1) correlations with other hot flash variables, 2) correlations with measures of affect and mood, 3) significant differences between women with hot flashes and those with out, and 4) demonstrated sensitivity over time (Carpenter, 2001). Pittsburgh Sleep Quality Index (PSQI) Sleep quality was assessed using the PSQI, which is a standardized measure of sleep quality. The PSQI (Appendix D) consis ts of 19 items which are combined to produce a global sleep quality score and 7 comp onent scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each of the component scores range from 0 (no difficulty) to 3 points (severe difficulty). These scores ar e summed to make the global score, which
19 ranges from 0-21 and reflects the number and se verity of sleep problems. This score was used to determine sleep quality. Global scores of 5 or greater indi cate poor sleep quality and high sleep disturbance. In addition to being indicative of poor sleep quality and high sleep disturbance, global scores of eight or more have been linked to cancer-related fatigue in survivors of breast cancer and other cancers (Carpenter & Andrykowski, 1998). In a psychometric evaluation of the PSQ I in 1998 by Carpenter and Andrykowski, the Cronbachs alpha coefficient was calculated as 0.80 for the global sleep score. Demographic and disease treatment information A demographic form (Appendix E) was us ed to assess demographic information, including birth date, ethnicity, and educati on level. Information was also gathered (Appendix F) from the medical record including date and st age at diagnosis, how long since last cancer treatment, wh at kind of treatments have been received, and when current anti-estrogen therapy started. Procedures This study involved several procedural st eps. The first step was approval from Moffitt Cancer Center Protocol Review a nd Monitoring Committee to conduct the study, followed by approval from the University of South Florida Institutional Review Board. Following approval, potential s ubjects were identified for inclusion criteria by clinic nurses in the Moffitt Cancer Center ambulatory clinic patients. Once identified, potential subjects were approached regarding study pa rticipation. An informed consent and HIPPA form was given to all participants (Appendix G and H). These forms included the title of the study, the principal investig ator, general information a bout the study, the plan of study, the benefits and the risks of particip ation, and a statement about confidentiality.
20 The study was explained, and all questions will be answered. After agreeing to participate, the woman then signed the consent form and a copy was given to the woman for her records. Following signed consent to participate, the women completed the Hot Flash Diary, Hot Flash Questionnaire, Hot Flash Related Daily Interference Scale, Pittsburgh Sleep Quality Index and a demogr aphic form. Completing these scales took about 15 minutes. Data Analysis The data analysis involved two steps. The first step was an analysis of demographic and treatment information usi ng descriptive statisti cs. The forms were composed of interval data and nominal data. Step two involved answering the research questions: In breast cancer survivors on a sele ctive estrogen receptor modulator: 1. Is there a relationship between hot flash frequency and sleep quality? 2. Is there a relationship between hot flash severity and sleep quality? 3. Is there a relationship between hot flash distress and sleep quality? 4. Is there a relationship between hot flash interference and sleep quality? The data in each question was analyzed us ing Pearsons correlations with alpha set at .05.
21 Chapter Four Results, Discussion and Conclusions This chapter presents the findings of th e study. Included in this chapter are the study results, discussion of the results, conclusi ons, and suggestions for future research. Results Demographic Data The sample consisted of 30 patients, a ll women with ages ranging from 36 to 65 years with a mean age of 54 (SD=8.2). Years of education ranged from 12 to 18 years with a mean of 14.2 years. The majority of pa tients (n=28) were Ca ucasian. The stage of disease reported most frequently was stage I. Stage 0 represents carcinoma in situ (Table 1). Table 1. Frequency and Per cent of Women by Ethnicity and Stage of Disease Variable Frequency Percent Ethnicity White 28 93.9 Hispanic 2 6.7 Stage 0 3 10 I 15 50 II 6 20 III 2 6.7 IV 1 3.3 Unknown 3 10 ________________________________________________
22 All of the patients had a dia gnosis of breast cancer, half of them with right sided occurrence (n=15). All of the women were ta king tamoxifen. Twelve patients reported that they had chronic illnesses. Types of cancer treatment are reported in Table 2. Table 2. Frequency and Percent of Wo men by Type of Cancer Treatment Medical Variable Frequency Percent Chemotherapy Yes 15 50 No 15 50 Type of SERM Tamoxifen 30 100 Breast Surgery Lumpectomy 20 66.7 MRM 5 16.7 RM 3 10 Unknown 2 6.7 Hysterectomy With oopherectomy 0 0 Without oopherectomy 3 10 No 27 90 Radiation Therapy Yes 17 56.7 No 13 43.3 _________________________________________________ Sleep Quality Sleep quality was determined by the PSQI. Using a formula, the global sleep quality was determined. A global sleep score above 5 is indicative of poor sleep quality and a score of 8 or more has been linked to cancer related fatigue in breast cancer patients. There are also some patients who are taking a sleep medication three or more times a week (16.7 %). The majority of wome n (n = 24) had global sleep scores greater
23 than 5, and 14 women (46.7 %) had global sleep scores greater than 8. Scores ranged from 2 to 18 on a scale of 0-21; the mean for all patients (n=30) was 9.33 (SD=4.4). Hot Flash Frequency The patients answered two different ques tions regarding frequency. The first was how many hot flashes they had experienced in the previous 24 hours and the second was how many of those were expe rienced while the patients we re sleeping. There were ten patients who experienced no hot flashes. A mean of 3.7 (SD=4.8) hot flashes were experienced by the patients in the previous 24 hours, the maximum number of hot flashes reported was 24 in a 24 hour period. A mean of 1.3 (SD= 1.6) of t hose occurring while the patient was sleeping, the maximum reporte d while sleeping was 7. The number of hot flashes experienced in 24 hours was found to ha ve a weak positive relationship with sleep quality, however the result was not statistically significant (r=.306, p= .10) (Table 3). The frequency of hot flashes experienced while sl eeping had a moderate, positive, statistically significant relationship with global sleep score (r=.507, p=.004) (Table 3). Table 3. Correlations Between Global Sl eep Scores and Hot Flash Experiences Global Sleep Score Hot Flashes r p Severity .718 .000 Distress .754 .000 24 hour Frequency .306 .100 Sleep Frequency .507 .004 Interference .680 .000 _________________________________________________________ Hot Flash Severity Severity of hot flashes was determined by multiplying the number of hot flashes experienced by the patient at each severity level and the severity level that they
24 experienced and dividing it by the number of total hot flas hes experienced. The mean was 1.16 (SD 9.9). This was on a scale from zero to four; zero equating to no hot flashes and four meaning all very severe hot flashes. The patients were given definitions to use to classify their hot flash severity. No patients re ported very severe hot flashes (Table 4). A strong, positive, statistically significant rela tionship was found between hot flash severity and global sleep score (r=.718, p=.000) (Table 3). Table 4. Number and Frequency of Hot Fl ashes Experienced by the Severity Score Severity Frequency Percent None 10 33.3 Mild 14 46.7 Moderate 12 40 Severe 9 30 Very Severe 0 0 _________________________________________________ Hot Flash Distress Distress was measured by a zero to te n scale, zero meaning no distress and ten meaning extremely distressed. The mean score was 3.4 (SD=3.5). A strong, positive, statistically significant relati onship was found between hot fl ash distress and global sleep score (r=.754, p=.000) (Table 3). Hot Flash Interference The hot flash interference score is a sum of ten questions. This number is on a scale of zero to one hundred, with zero impl ying hot flashes have no interference in the patients life, and one-hundred meaning the most possible interference in the patients life. Scores ranged from 0 to 75 with a mean interference score of 19.9 (SD=24.36). Hot
25 flash interference was found to have a st rong, positive, statistically significant relationship with global sleep sc ore (r=.680, p=.000) (Table 3). Discussion After approval from the Moffitt Cancer Center Protocol Review and Monitoring Committee and the University of South Flor ida Institutional Review Board, data was collected during the months of August through October of 2005. Few patients who were approached were unwilling to participate in this study. Demographic Data The sample consisted of a convenience sa mple of 30 breast cancer patients who were approached in an ambulatory care setti ng to participate in the study. The age range of patients participating in the study was 36 to 65 years of age with a mean of 54. This number is not representative of typical breast cancer patients due to the exclusion criteria. Women over the age of 65 were excluded from the study because previous studies have shown a decreased number of hot flashes on a SERM as women age. There were an equal numbers of women with right sided and left sided breast ca ncer. The sample was mostly Caucasian and few Hispanics with no Af rican-American subjects. This is not representative of the United States breast cancer patient population; 24% of those with breast cancer are African American a nd 18% are Hispanic (Ries, 2004). Another significant limitation of this study was the lack of patients found to be on a SERM. Rather, patients who are taking aromat ase inhibitors (AI) as their anti-estrogen therapy seemed to be much more common. This is partly due to studies that have recently been published supporting AI therapy in bot h postmenopausal women and women with a breast cancer recurre nce. Although hot flashes have been proven to be a bothersome side
26 effect for women who are taking a SERM, the AI had fewer incidences of hot flashes in preliminary studies. However, there is newer literature stating hot flashes are just as common in women who are taking an AI as those taking a SERM (Morales, 2004). Future research should compare the two cl asses of drugs according to womens sleep quality. Sleep Quality The mean global sleep quality score for these patients was 9.33, which indicates poor sleep quality. However, it is not only hot flashes that may influence sleep quality. Cancer patients typically ha ve sleep problems related to their cancer diagnosis and disease process. Some patients in the sample were taking a sleep medication three or more times a week (16.7 %). This could have improved their sleep quality regardless of hot flashes. There are also many patients w ho are taking anti-depressant medications in the selective serotonin receptor modulator cl ass in which a common side effect from these drugs is insomnia (Karch, 2006). Thus there were confounding factors that might have influenced sleep quality. Hot Flash Frequency The time of the day that the hot flashes we re experienced played a very important role when considering frequency. The frequency of hot flashes experienced during the day had no significant relationshi p to sleep quality. Only the frequency of hot flashes at night were influential on patients sleep quality. This finding supports earlier research by Carpenter, Gautam, Freedman and Andrykow ski (2001) which both used objective hot flash data collection from skin conductan ce monitoring and a 24 hour diary. This data also supports research done by Savard et al (2004) which also used objective measures
27 including hot flash skin conductance monitoring and obj ective sleep monitoring by polysomnography, EEG, EMG and EOG readings. Hot Flash Severity The severity of hot flashes had a very significant relationshi p with global sleep quality scores. There were no patients who re ported having very severe hot flashes, yet it appears that the severity wa s strong enough to impact sleep quality. Women do not have to have severe hot flashes for them to be aff ecting their sleep. Limitations to this variable would include that some patients needed furt her prompting to quantify a number of hot flashes in each severity category. Hot Flash Distress Distress was quantified by one item. This one item had the strongest correlation with sleep quality scores. It is, therefore, the biggest predictor of poor sleep quality. Asking a woman how bothered she is by her hot flashes on a scale from 0 to 10 will predict how she is sleeping. This is a vital piece of information to be gathered when caring for her. A decreased sleep quality may then be addressed. Although the validity of this item has not been published, this st rong, significant relationship would tend to support its validity. Hot Flash Interference The relationship between hot flash interf erence and global sleep score was strong and positive. The influence that hot flashes have on all aspects of the woman life correlates with the lack of sl eep quality. Therefore, if wo men are having a difficult time sleeping because of their hot flashes they ar e most likely having trouble with hot flashes interfering with other life issu es such as sexuality and enjoyment and quality of life. This
28 instrument was previously shown to have good reliability and validity, and results of this study further support its validity. Conclusions Hot flashes are a very common symptom for women who are taking a SERM. It seems that it is not the number of hot flashes alone that is decreasi ng the sleep quality of these women, but how distressing, severe a nd interfering the symptom is to them. Although results do not demonstrate a cause and effect, they do suggest that relieving hot flashes may have a positive effect on other aspects of quality of life including sleep. Recommendations for future research The prominence of aromatase inhibitors in the breast cance r population warrants similar studies with those medications, even comparing them with SERMs. A larger sample size, having a multi-site study in a broader geographical ar ea and recruiting more African American women would all be recommendations for future research. Oncology nursing education should include content about the likelihood of hot flashes and their impact not only on sleep qua lity, but on all aspects of everyday life. Assessment of hot flashes is one of the most im portant things nurses can do to assist their patients who are taking a SERM. Nurses s hould inquire about how bothersome the hot flashes are and ask if the hot flashes are interfering with sleep. Recommending techniques to improve sleep quality to women experiencing hot flashes is also appropriate.
29 References American Psychiatric Associa tion (1994), Diagnostic and sta tistical manual of mental disorders, 4 th edition (DSM-IV). Washington, DC: American Psychiatric Association Barton, D. L., Loprinzi, C. L., Quella, S. K., Sloan, J. A., Veeder, M. H., & Egner, J. R. et al. (1998). Prospective ev aluation of vitamin E for hot flashes in breast cancer survivors. Journal of Clinical Oncology, 16, 495-500. Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28, 193-213. Carpenter, J.S. (2001) The hot flash related daily interference scale: A tool for assessing the impact of hot flashes on quali ty of life following breast cancer. Journal of Pain and Symptom Management, 22, 979-989. Carpenter, J. S., & Andrykowski, M. A. (1998). Psychometric evaluation of the Pittsburgh Sleep Quality Index. Journal of Psychosomatic Research, 45, 5-13. Carpenter, J. S., & Andrykowski, M. A. ( 1999). Menopausal symptoms in breast cancer survivors. Oncology Nursing Forums, 26, 13111317. Carpenter, J. S., Andrykowski, M. A., Cordova, M., Cunningham, L., Studts, J., & McGrath, P. et al. (1998). Hot flashes in postmenopausal women treated for breast carcinoma: Prevalence, severity, correlates, management, and relation to quality of life. Cancer, 82, 1682-1691. Carpenter, J. S., Elam, J. L., Ridner, S. G., Carney, P. H., Cherry, G. J., & Cucullu, H. L. (2004). Sleep, fatigue, and depressive sy mptoms in breast can cer survivors and matched healthy women experiencing hot flashes. Oncology Nursing Forum, 31, 591-598. Carpenter, J. S., Gautam, S., Freedman, R. R., & Andrykowski, M. (2001, May). Circadian rhythm of objectively recorded hot flashes in postmenopausal breast cancer survivors. Menopause, 8, 181-188. Retrieved May 20, 2004, from Ovid database.
30 Carpenter, J. S., Johnson, D. H., Wagner, L. J., & Andrykowski, M. A. (2002, April). Hot Flashes and Related Outcomes in Br east Cancer Survivors and Matched Comparison Women. Oncology Nursing Forum, 29, 1-19. Retrieved May 17, 2004, from http://journals.ons.org Engstrom, C., Strohl, R., Rose, L., Lewandow ski, L., & Stefanek, M. (1999). Sleep alterations in cancer patients. Cancer Nursing, 22, 143-148. Erlik, Y., Tataryn, I. V., Meldrum, D. R., Lomax, P., Bajorek, J. G., & Judd, H. L. (1981). Association of Waking Episode s with Menopausal Hot Flushes. Journal of the American Medical Association, 245, 1741-1744. Ferrel, B. R., (1996). The quality of lives: 1,525 voices of cancer. Oncology Nursing Forum, 23, 909-915. Finck, G., Barton, D. L., Loprinzi, C. L., Que lla, S. K., & Sloan, J. A. (1998). Definitions of Hot Flashes in Breast Cancer Survivors. Journal of Pain and Symptom Management, 16, 327-333. Fortner, B. V., Stepanski, E. J., Wang, S. C., Kasprowicz, S., & Durrence, H. H. (2002). Sleep and quality of life in breast cancer patients. Journal of Pain and Symptom Management, 24, 471-480. Jacobson, J. S., Troxel, A. B., Evans, K., Klau s, L., Vahdat, L., & Kinne, D. et al. (2001). Randomized trial of black cohosh for th e treatment of hot flashes among women with a history of breast cancer. Journal of Clinical Oncology, 19, 2739-2745. Karch, A.M. (2006) 2006 Lippincotts nursi ng drug guide. Philadelphia: Lippincott, Williams & Wilkins. Kravitz, H. M., Ganz, P. A., Bromberger, J., Powell, L. H., Sutton-Tyrrell, K., & Meyer, P. M. (2003). Sleep difficulty in women at midlife: a community survey of sleep and the menopausal transition. Menopause, 10, 19-28. Larson, P. J., Carrieri-Kohlman, V., Dodd, M. J ., Douglas, M., Faucett, J., & Froelicher, E. et al. (1994). A Model for Symptom Management. IMAGE: Journal of Nursing Scholarship, 26, 272-276. Loprinzi, C. L., Kugler, J. W., Sloan, J. A., Malliard, J. A., LaVasseur, B. I., & Barton, D. L. et al. (2000). Venlafaxine in mana gement of hot flashes in survivors of breast cancer: A randomized controlled trial. The Lancet, 356, 2059-2063. McPhail, G., & Smith, L. N. (2000). Acut e menopause symptoms during adjuvant systemic treatment for breast cancer. Cancer Nursing, 23, 430-443.
31 Morales L. Neven P. Timmerman D. Christiaen s MR. Vergote I. Van Limbergen E. et al. (2004) Acute effects of tamoxifen and third-generation aromatase inhibitors on menopausal symptoms of breast cancer patients Anti-Cancer Drugs. 15, 753-60. Ries L.A.G., Eisner M.P., Kosary C.L., Hanke y B.F., Miller B.A., Clegg L., Mariotto A., Feuer E.J., Edwards B.K. (eds). SEER Cancer Statistics Review, 1975-2001, National Cancer Institute. Bethesda MD, http://seer.cancer.gov/csr/1975_2001/, 2004. Savard, J., Davidson, J. R., Ivers, H., Quesne l, C., Rioux, D., & Dupere, V. et al. (2004). The association between nocturnal hot flashes and sleep in breast cancer survivors. Journal of Pain and Symptom Management, 27, 513-522. Savard, J., & Morin, C. M. (2001). Insomnia in the Context of Cancer: A review of a Neglected Problem. Journal of Clinical Oncology, 19 895-908. Shanafelt, T. D., Barton, D. L., Adjei, A. A., & Loprinzi, C. L. (2002). Pathophysiology and Treatment of Hot Flashes. Mayo Clinic Proceedings, 77 1207-1218. Sloan, J. A., Loprinzi, C. L., Novotny, P. J., Barton, D. L., Lavasseur, B. I., & Windschitl, H. (2001). Methodologic lessons learned from hot flash studies. Journal of Clinical Oncology, 19, 4280-4290. Stein, K. D., Jacobsen, P. B., Hann, D. M ., Greenberg, H., & Lyman, G. (2000). Impact of hot flashes on quality of life among postmenopausal women being treated for breast cancer. Journal of Pain and Symptom Management, 19, 436-445.
Appendix A: Hot Flash Diary 1. How many hot flashes have you had in the past 24 HOURS? _____ 2. How many of those were while you were sleeping? _____ 3. Using the attached sheet as a guide, tell me how many of the hot flashes you have had in the past 24 HOURS were mild, moderate, severe, or very severe. _____ mild _____ moderate _____ severe _____ very severe 4. How bothered are you by your hot flashes on a scale from 0 to 10 (0 is not bothered at all, 10 is extremely bothered)? ____ 33
Appendix B: Hot Flash Severity Definitions 34
Appendix C: Hot Flash Related Daily Interference Scale Please circle one number to the right of each phrase to describe how much DURING THE PAST WEEK, hot flashes has INTERFERED with each aspect of your life. Does not Completely Interfere interferes 1. Work (work outside the home and housework) 0 1 2 3 4 5 6 7 8 9 10 2. Social activities (time spent with family, friends, etc) 0 1 2 3 4 5 6 7 8 9 10 3. Leisure activities (time spent relaxing, doing hobbies, etc.) 0 1 2 3 4 5 6 7 8 9 10 4. Sleep 0 1 2 3 4 5 6 7 8 9 10 5. Mood 0 1 2 3 4 5 6 7 8 9 10 6. Concentration 0 1 2 3 4 5 6 7 8 9 10 7. Relations with others 0 1 2 3 4 5 6 7 8 9 10 8. Sexuality 0 1 2 3 4 5 6 7 8 9 10 9. Enjoyment of life 0 1 2 3 4 5 6 7 8 9 10 10. Overall quality of life 0 1 2 3 4 5 6 7 8 9 10 35
Appendix D: Pittsburgh Sleep Quality Index The following questions relate to your usual sleep habits DURING THE PAST SIX WEEKS. Your answers should reflect the majority of days and nights during the past six weeks. 1. During the PAST SIX WEEKS, when have you usually gone to bed at night? ______ Usual bed time 2. During the PAST SIX WEEKS, how long has it usually taken you to fall asleep at night? ______ Number of minutes 3. During the PAST SIX WEEKS, when have you usually gotten up in the morning? ______ Usual getting up time 4. During the PAST SIX WEEKS, how many hours of actual sleep did you get at night? (This may be different than the number of hours you spent in bed.) ______ Hours of sleep per night For each of the remaining questions, check the one best response. Please answer all questions. During the PAST SIX WEEKS, how often have you had trouble sleeping because you Not during the past month Less than once a week Once or twice a week Three or more times a week 5. Cannot get to sleep within 30 minutes 0 1 2 3 6. Wake up in the middle of the night or early morning 0 1 2 3 7. Have to get up to use the bathroom 0 1 2 3 8. Cannot breathe comfortably 0 1 2 3 9. Cough or snore loudly 0 1 2 3 10. Feel too cold 0 1 2 3 11. Feel too hot 0 1 2 3 12. Had bad dreams 0 1 2 3 13. Have pain 0 1 2 3 14. Other reasons 0 1 2 3 36
Appendix D: Pittsburgh Sleep Quality Index 15. During the PAST SIX WEEKS how would you rate your sleep quality overall? (CHECK ONE) ______ Very good ______ Fairly good ______ Fairly bad ______ Very bad 16. During the PAST SIX WEEKS, how often have you taken medicine (prescribed or over the counter) to help you sleep? (CHECK ONE) ______ Not during the past month ______ Less than once a week ______ Once or twice a week ______Three or more times a week 17. During the PAST SIX WEEKS, how often have you had trouble staying awake while driving, eating meals, or engaging in social activities? (CHECK ONE) ______ Not during the past month ______ Less than once a week ______ Once or twice a week ______Three or more times a week 18. During the PAST SIX WEEKS, how much of a problem has it been for you to keep up enough enthusiasm to get things done? (CHECK ONE) ______ No problem at all ______ Only a very slight problem ______ Somewhat of a problem ______ A very big problem 19. Do you have a bed partner or roommate? (CHECK ONE) ______ No bed partner or roommate ______ Partner/roommate in other room ______ Partner/roommate in same room, but not in same bed ______ Partner in same bed 37
Appendix E: Demographic Questionnaire DEMOGRAPHIC QUESTIONNAIRE What is your age? ______ (on your last birthday) What is your ethnicity? White _____ (1) African-American _____ (2) Hispanic _____ (3) American Indian _____ (4) Asian _____ (5) Pacific Islander _____ (6) Please circle the highest grade of education you completed. 1 2 3 4 5 6 7 8 9 10 11 12 (high school) 13 14 15 16 (college) 17 18 (masters degree) 19 20 (doctorate) What medications or supplements are you currently taking? (Please list all vitamins, herbs, supplements, and medications, including pills, inhalers, injections, and creams) ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Do you have any chronic medical problems, such as arthritis or high blood pressure? ___ no (0) ___ yes (1), please list any medical problems: ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ 38
Appendix F: Disease and Treatment Information DISEASE & TREATMENT INFORMATION (To be filled out by researcher) DIAGNOSIS Date: ____-____-____ Location: ___ left (1)___ right (2)___ bilateral (3) Stage: T ___ N ___ M ___ X _____ (0) (any Tx, any Nx, any Mx) 0 _____ (1) I _____ (2) IIA _____ (3) IIB _____ (4) IIIA _____ (5) IIIB _____ (6) IV _____ (7) SURGERY Date: ____-____-____ Type: _____ lumpectomy (1) _____ MRM (2) _____ RM (3) _____ other (4) Hysterectomy: ___ yes, with oopherectomy (1) ___ yes, without oopherectomy (2) ___ no (3) CHEMOTHERAPY _____ none (0) _____ some (1), # cycles received? _____ Begin date: ____-____-____ End date: ____-____-____ ANTI-ESTROGEN THERAPY (current use) ___ no (0) ___ tamoxifen (Nolvadex)(1) ___ toremifene (Fareston) (2) ___ raloxifene (Evista) (3) Begin date: ____-____-____ End date: ____-____-____ RADIATION THERAPY _____ none (0) _____ some (1) Begin date: ____-____-____ End date: ____-____-____ Complete Treatment Received: _____ surgery alone (1) _____ surgery + XRT (2) _____ surgery + chemo (3) _____ surgery + XRT + chemo (4) Date of last treatment: ____-____-____ 39