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Fatigue symptom distress and its relationship with quality of life in adult stem cell transplant survivors

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Title:
Fatigue symptom distress and its relationship with quality of life in adult stem cell transplant survivors
Physical Description:
Book
Language:
English
Creator:
Abduljawad, Suzan Fouad
Publisher:
University of South Florida
Place of Publication:
Tampa, Fla
Publication Date:

Subjects

Subjects / Keywords:
Bone Marrow Transplantation   ( mesh )
Stem Cell Transplantation   ( mesh )
Neoplasms -- complications   ( mesh )
Neoplasms -- therapy   ( mesh )
Fatigue -- prevention & control   ( mesh )
Quality of Life   ( mesh )
Prevalence   ( mesh )
Questionnaires   ( mesh )
Cancer
Adults
Persistent fatigue
Survivors
Bone marrow transplant
Dissertations, Academic -- Nursing -- Masters -- USF   ( lcsh )
Genre:
non-fiction   ( marcgt )

Notes

Summary:
ABSTRACT: Fatigue is a common problem among cancer patients, especially those who have received chemotherapy and radiation therapy. Stem cell transplant (SCT) patients are at a particular risk of persistent fatigue as they receive more aggressive therapies. This study examined the prevalence of fatigue after completion of SCT. Further, the level of fatigue symptom distress and its relationship with quality of life (QOL) among long term SCT survivors was examined. The study involved thirty-three patients, 21 males and 12 females, treated with autologous or allogeneic SCT in a comprehensive cancer center in Southwest Florida. Participants' ages ranged from 36 to 70 years, with a mean age of 53 years. All subjects completed the Cancer Related Fatigue Distress Scale and the Functional Assessment of Cancer Therapy-Bone Marrow Transplant questionnaires. All the patients had to be at least six months from transplant.The results of this study showed that fatigue is quite prevalent among SCT survivors. Ninety-three percent of the patients reported some degree of fatigue, and 15% experienced severe fatigue. Patients who received autologous transplant (24%) reported less fatigue symptom distress (mean= 48, SD= 36.62) compared to the allogeneic transplant group (mean= 66.2, SD= 54.49). A strong negative relationship was found between fatigue symptom distress and QOL (r = 0.85, p < 0.0001) suggesting that patients with the greatest fatigue distress report the worst QOL. The time from transplant factor was significantly positively associated with fatigue symptom distress (r= 0.46, p= 0.007) indicating greater distress with the passage of time. A moderate negative relationship was also found between time from transplant and QOL (r= -0.34, p= 0.052) suggesting that QOL was less in some patients as time passed; however this was a weak relationship that did not achieve statistical significance.Although the sample size was small, this study was able to provide a confirmation that fatigue symptom distress and QOL are related to one another. Understanding the relationship between fatigue symptom distress and QOL should encourage interdisciplinary collaboration in planning proper interventions to minimize fatigue. This would improve the outcomes of SCT long term survivors, and would positively impact their overall QOL.
Thesis:
Thesis (M.S.)--University of South Florida, 2009.
Bibliography:
Includes bibliographical references.
System Details:
Mode of access: World Wide Web.
System Details:
System requirements: World Wide Web browser and PDF reader.
Statement of Responsibility:
by Suzan Fouad Abduljawad.
General Note:
Title from PDF of title page.
General Note:
Document formatted into pages; contains 52 pages.

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University of South Florida
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All applicable rights reserved by the source institution and holding location.
Resource Identifier:
aleph - 002063810
oclc - 557558154
usfldc doi - E14-SFE0003240
usfldc handle - e14.3240
System ID:
SFS0027556:00001


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ABSTRACT: Fatigue is a common problem among cancer patients, especially those who have received chemotherapy and radiation therapy. Stem cell transplant (SCT) patients are at a particular risk of persistent fatigue as they receive more aggressive therapies. This study examined the prevalence of fatigue after completion of SCT. Further, the level of fatigue symptom distress and its relationship with quality of life (QOL) among long term SCT survivors was examined. The study involved thirty-three patients, 21 males and 12 females, treated with autologous or allogeneic SCT in a comprehensive cancer center in Southwest Florida. Participants' ages ranged from 36 to 70 years, with a mean age of 53 years. All subjects completed the Cancer Related Fatigue Distress Scale and the Functional Assessment of Cancer Therapy-Bone Marrow Transplant questionnaires. All the patients had to be at least six months from transplant.The results of this study showed that fatigue is quite prevalent among SCT survivors. Ninety-three percent of the patients reported some degree of fatigue, and 15% experienced severe fatigue. Patients who received autologous transplant (24%) reported less fatigue symptom distress (mean= 48, SD= 36.62) compared to the allogeneic transplant group (mean= 66.2, SD= 54.49). A strong negative relationship was found between fatigue symptom distress and QOL (r = 0.85, p < 0.0001) suggesting that patients with the greatest fatigue distress report the worst QOL. The time from transplant factor was significantly positively associated with fatigue symptom distress (r= 0.46, p= 0.007) indicating greater distress with the passage of time. A moderate negative relationship was also found between time from transplant and QOL (r= -0.34, p= 0.052) suggesting that QOL was less in some patients as time passed; however this was a weak relationship that did not achieve statistical significance.Although the sample size was small, this study was able to provide a confirmation that fatigue symptom distress and QOL are related to one another. Understanding the relationship between fatigue symptom distress and QOL should encourage interdisciplinary collaboration in planning proper interventions to minimize fatigue. This would improve the outcomes of SCT long term survivors, and would positively impact their overall QOL.
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Neoplasms
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Neoplasms
therapy.
Fatigue
prevention & control.
Quality of Life.
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Adults
Persistent fatigue
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PAGE 1

Fatigue Symptom Distress and Its Relationshi p with Quality Of Life in Adult Stem Cell Transplant Survivors by Suzan Fouad Abduljawad, R.N., B.S.N. A thesis submitted in partial fulfilment of the requirements for the degree of Master of Science College of Nursing University of South Florida Major Professor: Susan C. McMillan, Ph.D., A.R.N.P. Cindy S. Tofthagen, Ph.D., A.R.N.P. Brandy L. Lehman, Ph.D., R.N. Date of Approval: November 16, 2009 Keywords: cancer, adults, persistent fa tigue, survivors, bone marrow transplant. Copyright 2009 Suzan Fouad Abduljawad

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DEDICATION This thesis is dedicated to my outst anding mother, Khadija Elmoujarrad. Her devotion, hard work, and thirst for knowledge inspired my motivation to pursue my Master of Science degree, and the completion of this thesis. Thank you mother, your endless love, support, prayers and encourag ement put me on the road to success. To my deceased father, Fouad Abduljawad, who had always encouraged me to learn and dream big, I wish you were here to witne ss the success of your daughter getting the honor of being the first female to attain the Masters degree in th e family. I would like to also dedicate this thesis to my hus band, Abdullah Wolkens, for his love, support, and willingness to put my needs before his own. Thank you for believing in me. And last but not least, I dedicate this to my beloved family. Grandmother Aicha El-Eidi and Grandfather Jeloul Elmoujarrad, thank you for your unconditional love and your continuous prayers; my brother Feras, who in spired me with his enthusiasm for higher education and greater knowledge; my brothe r Fahad and sister Sundus, I appreciate your love and encouragement, I hope you ma y find this thesis a source for your own inspiration. I am blessed to have ea ch and every one of you in my life.

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ACKNOWLEDGMENTS All Praises to Allah, Lord of the Un iverse, thank you for the strength that keeps me standing and for the faith that br ought light to my path and guided me. I am forever in debt for your blessings with the people who have given their heart whelming full support and encouragement in preparation of this thesis. I would like to thank Dr. Susan McM illan, for the direction throughout this project. I am short of words to express my gratitude for your guidance, your encouragement, your tireless support, and above all because you had faith in my success. I would also like to acknowledge my thesis committee members, Dr. Cindy Tofthagen and Dr. Brandy Lehman for thei r time and contribution. I am extremely grateful to Dr. Dee Dee Boyington for her in valuable help and support of my research study. When new obstacles presented at ever y turn in the road to approval I was blessed by having you help push it through. I am thankful to Doreen Appunn, MCC Division of Research Compliance, for her great help and guidance. Many thanks to Trudy Wittenberg USF unit research administrator, for helping me through my IRB application. And finally, I am grateful to all the men and women who took part in my study for seeing its value and taking the time to participate.

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i Table of Contents List of Tables ............................................................................................................... iii Abstract ...................................................................................................................... .. iv Chapter I Introduction ....................................................................................................1 Statement of Problem .........................................................................................1 Research Questions ............................................................................................2 Definition of Terms............................................................................................2 Significance to Nursing......................................................................................3 Chapter II Review of Literature .....................................................................................5 Fatigue................................................................................................................5 Quality of Life..................................................................................................12 Summary ..........................................................................................................15 Chapter III Methods .....................................................................................................17 Setting and Sample ..........................................................................................17 Instrumentation ................................................................................................18 Cancer Related Fatigue Di stress Scale (CRFDS) ................................18 Validity and Reliability ............................................................19 Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)...............................................................19 Validity and Reliability ............................................................20 Demographic data Form ......................................................................20 Procedures ........................................................................................................21 Approvals .............................................................................................21 Data Collection ....................................................................................21 Data Analysis .......................................................................................22 Chapter IV Results, Discussion and Conclusions ........................................................24 Results ..............................................................................................................24 Sample..................................................................................................24 Fatigue Intensity and Symptom Distress .............................................26 Relationship between Fati gue Symptom Distress and QOL................28 Relationship between Fatigue Sy mptom Distress and Time from Transplant ......................................................................................28 Relationship between QOL and Time from Transplant .......................28 Discussion ........................................................................................................29 Sample..................................................................................................29 Fatigue Symptom Distre ss and Quality of Life ...................................30 Relationship between Fati gue Symptom Distress and QOL................31

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ii Relationship between Time from Transplant, Fatigue Symptom Distress and QOL ...........................................................................31 Conclusions ......................................................................................................32 Implications for Nursing ......................................................................32 Implications for Research ....................................................................33 References .................................................................................................................... 34 Appendices ...................................................................................................................3 6 Appendix A: Cancer Related Fa tigue Distress Scale (CRFDS) ......................37 Appendix B: Functional Assessment of Cancer TherapyBone Marrow Transplant ..................................................................................................41 Appendix C: Demographic Data/Hea lth History Information Form ...............44 Appendix D: Informed Consent .......................................................................45 Appendix E: Moffitt Cancer Center Scie ntific Review Co mmittee approval .50 Appendix F: Institutiona l Review Board Approval .........................................52

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iii List of Tables Table 1 Demographics and Clinical Characteristics of Patients .......................25 Table 2 Diagnoses and Type of Transplant ......................................................26 Table 3 Fatigue Intensity Score ........................................................................27 Table 4 Total Scores of CRFDS and FACT-BMT ...........................................28 Table 5 Pearson Correlation Coeffi cients between Fatigue Symptom Distress, Quality of Life, and Time from Transplant ...........................29

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iv Fatigue Symptom Distress and Its Relationshi p with Quality Of Life in Adult Stem Cell Transplant Survivors Suzan Fouad Abduljawad ABSTRACT Fatigue is a common problem among can cer patients, especially those who have received chemotherapy and radiati on therapy. Stem cell transplant (SCT) patients are at a particular ri sk of persistent fatigue as they receive more aggressive therapies. This study examined the preval ence of fatigue after completion of SCT. Further, the level of fatigue symptom distre ss and its relationship with quality of life (QOL) among long term SCT survivors was examined. The study involved thirty-three patients 21 males and 12 females, treated with autologous or allogeneic SCT in a comprehe nsive cancer center in Southwest Florida. Participants ages ranged from 36 to 70 y ears, with a mean age of 53 years. All subjects completed the Cancer Related Fa tigue Distress Scal e and the Functional Assessment of Cancer Therapy-Bone Ma rrow Transplant questionnaires. All the patients had to be at least si x months from transplant. The results of this study showed th at fatigue is quite prevalent among SCT survivors. Ninety-three percent of the patients reported some degree of fatigue, and 15% experienced severe fati gue. Patients who received autologous transplant (24%) reported less fatigue symptom distress (mean= 48, SD= 36.62) compared to the

PAGE 8

v allogeneic transplant group (mean= 66.2, SD= 54.49). A strong negative relationship was found between fatigue symptom distress and QOL (r = 0.85, p < 0.0001) suggesting that patients with the greate st fatigue distress report the worst QOL The time from transplant factor was significan tly positively associated with fatigue symptom distress (r= 0.46, p= 0.007) indicating greater dist ress with the passage of time. A moderate negative relationship was also found between time from transplant and QOL (r= -0.34, p= 0.052) suggesting that QOL was le ss in some patients as time passed; however this was a weak relati onship that did not achieve statistical significance. Although the sample size was small, this study was able to provide a confirmation that fatigue sy mptom distress and QOL are related to one another. Understanding the relationship between fa tigue symptom distress and QOL should encourage interdisciplinary collaboration in planning proper interventions to minimize fatigue. This would improve the outcomes of SCT long term survivors, and would positively impact their overall QOL.

PAGE 9

Chapter I Introduction Fatigue is a common symptom of can cer that has been demonstrated by research to be one of the most distressi ng symptoms associated with cancer and all cancer treatment modalities including chemot herapy, surgery, biotherapy, radiation therapy, and bone marrow transplantation. It is reported that 70 to 100% of patients who are undergoing cancer treatment suffer from fatigue at some or all stages of their illness (Flude, Groll, Tranmen, & Woodend, 2007). This distressing symptom can interfere with many aspects of QOL, includ ing physical, psychosocial and spiritual well being. Cancer patients undergoing stem cell transplant (SCT) are subject to receiving high doses of chemotherapy and radiation therapy in bone marrow conditioning regimens prior to transplant. The side effects from this multi-treatment approach often precipitate heightened levels of fati gue (Gielissen et al., 2007). Persistent burden on the physical and psychol ogical status contributes to decreased levels of activity, cognitive ability and the resultant poor sense of well being (Harder et al., 2002). Certainly sympto m management is a priority for those who strive to improve patients outcomes. With growi ng evidence that SCT patients suffer from persistent fatigue, it should be equally impor tant for the clinicians and researchers to understand this phenomenon and examine its re lationship to QOL of SCT survivors. Statement of the Problem Fatigue is a common side effect that can be expected in the immediate recovery period of SCT (El-Banna et al ., 2004). When the transplantation journey 1

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concludes, the patients hope to regain their pre-diagnosis health status, functional ability, and their psychological social and spiritual well being, to again lead their lives somewhat normally. Unfortunately, so me patients experience a lingering fatigue that begins with their diagnosis of cancer, and continues in some cases for years after the completion of successful therapy. However, the factors contributing to the persistence of this problem and its impact on overall survival remains poorly understood. Thus, this study sought to descri be the phenomenon of persistent fatigue, and how fatigue symptom distress is relate d to quality of life in long term SCT survivors. Research Questions The following questions guided the study: 1. What is the prevalence of fatigue and the level of fatigue symptom distress reported by cancer patients at least six months past completing SCT? 2. What do patients report their QOL to be at least six months after SCT? 3. Is there a significant relationship betw een fatigue symptom distress and QOL of cancer patients at least six months after SCT? 4. Is there a significant relationship between fatigue and time from transplant? 5. Is there a significant relationship be tween QOL and time from transplant? Definition of Terms For the purpose of this paper th e following definitions are used. Fatigue: An unusual, sustained, subjective se nse of tiredness, malaise or lack of energy, related to cancer or cancer treatment that inte rferes with usual functioning (The National Comprehensive Cancer Network [NCCN], 2008). Fatigue Symptom Distress: It is the distress and suffering that accompanies the experience of the fatigue symptom (Holley, 2000). 2

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Quality of life : Is a subjective multidimensional construct that represents aspects of the individuals sa tisfaction with well being. It is defined as the difference or gap between the current hopes and e xpectation of the i ndividual and that individual's present experiences (Frick, Borasio, Zehentner, Fischer, & Bumeder 2004). Stem cell transplantation : Is a procedure used to restore the stem cells when the bone marrow has been destroyed by diseas e, radiation or chemotherapy. Depending on the source of the stem cells, this pro cedure may be called a bone marrow transplant (BMT), a peripheral blood stem cell transplant (PBSCT), or a cord blood transplant (American Cancer Society, 2009). Autologous stem cell transplantation (ASCT): A procedure in which bloodforming stem cells are harvested from the blood stream, stored, and later transfused back to the same person (American Cancer Society, 2009). Allogeneic stem cell tr ansplantation (aSCT): A procedure in which a person receives blood-forming stem cells from a ge netically similar, but not identical, donor. This is often a sister or brother, but c ould be an unrelated donor (American Cancer Society, 2009). Significance to Nursing Describing the post transplant fatigue phe nomenon is of particular significance in improving SCT patients outcomes. In order to be able to design and achieve optimal management of this distressing sy mptom, healthcare professionals need to understand the magnitude of the problem. Th e knowledge of prevalence and severity of fatigue reported by cancer patients after SCT, coupled with examining the quality of life in relation to reports of the fatigue distress should help focus post transplant nursing care. The information ob tained from this study can assist nursing clinicians 3

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and researchers, who strive to improve pa tients outcomes, in recognizing the impact of fatigue on quality of life. This will further refine the clinicians timing of supportive interventions and the content of education they provide to patients. 4

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Chapter II Review of Literature This chapter presents the review of litera ture that is associated with fatigue and the quality of life following SCT treatment in patients with hematologic malignancies. First studies of fatigue are reviewed. This is followed by studies of quality of life, and finally the literature is summarized. Fatigue In the past two decades, stem cell transplantation, following a conditioning regimen of intensive high dose chemothera py with or without total body irradiation, has been used increasingly as means for a potential cure of many hematologic diseases and malignancies (Hjermstad et al., 2004). This approach to treatment, despite its effectiveness in decreasing mortalit y, is often complicat ed with unpleasant symptoms and side effects that can be extremely daunting and at times even life threatening. The incidence and intensity of cancer related fatigue in BMT recipients varies over the course of treatmen t and recovery. In a longit udinal study, El-Banna et al. (2004) described the temporal patterns of depression and the four dimensions of cancer related fatigue includi ng: behavioral, sensory, cogni tive and affective meaning. Twenty-seven adult patients with ly mphoma undergoing autologous stem cell transplantation (ASCT) were included in this study. Fatigue was measured over multiple time points; at baseline before chemotherapy initiation, on chemotherapy day, and on recovery at days 2, 7, and 14. Th e authors used the revised Piper Fatigue 5

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Scale (PFS), a multidimensional self-report fatigue instrument, on which high scores indicate higher levels of perceived fatigue. El-Banna et al. (2004) found variations over the two-week period following ASCT. Th e patients reported si gnificant increase of PFS scores from baseline to day seven for total fatigue and all dimensions of fatigue except the cognitive or mood subscal e. The pattern showed a decline after day 14 of transplantation. To measure depression, The Center for Epidemiologic Studies Depression (CES-D) Scale was used. Total scores on the CES-D scale range from zero (no depression) to 60 (severe depressi on). A score of 16 or more on the CES-D scale indicates depressive symptoms. The authors also found depression presenting a similar pattern of sharp increase on day seve n and a gradual declin e afterwards with a high positive correlation between a ffective fatigue and depression ( p < 0.01). The findings of this study highlight the importance of continuity of care, measuring fatigue with concurrent assessment for depr ession, and paying clos e attention to the immediate recovery period where the peak of these symptoms seems to occur. From the NCCN definition of fatigue one can find the concept of fatigue rendered with much influence on physica l activity and functional ability. In a prospective study, Hacker et al (2006) sought to examine the feasibility of obtaining real-time fatigue and physical activity da ta, to describe the patterns of fatigue, physical activity, health status and quality of life before and after hematopoietic stem cell transplantation (HSCT). Twenty adult patients undergoing autologous or allogeneic HSCT participated in the study. To assess fatigue, two different measures were used, the fatigue subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30) and the Actiwatch (a wrist actigraph with a subj ective event marker which was used as a self report scale to measure real-time fatigue intensity). The Actiwatch was also used 6

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to measure physical activity of the pati ents as the device consisted of an accelerometer that records motion and speed of the subject. The Quality of Life Index (QLI) was used to measure life satisfaction related to the domains of family, health a nd functioning, social and economic, and psychological or spirituality. The majority of the patient s were found to experience mild fatigue at baseline, which escala ted following HSCT to significantly higher levels ( p<0.001). Also after HSCT physical activity markedly decreased by 58% and overall health status became significantly wo rse. The significant decline in patients physical, emotional and cognitive functioning seemed to peak in the immediate posttransplant period. The authors also found this decline in functioning and physical activity associated with significant increases in symptoms of fatigue, pain, nausea and vomiting, diarrhea, loss of appetite and sleep disturbance. The QLI scores of socioeconomic and psychological or spir itual subscales showed no significant changes in this study, allowing the authors to support the notion that a lag time exists between actual experiencing of health stat us changes and assimilating those changes into an appraisal of life s circumstances (Hacker et al., 2006). The study findings suggest that patients experien ce prolonged fatigue and physical inactivity for at least 7 to 14 days following HSCT. This prolonged inactivity may eventually lead to reduction of muscle mass and loss of strength and functional capacity. The consequences of this diminished functiona l capacity are of particular concern with patients ability to maintain or return to th eir productive roles in society (Hacker et al., 2006). Therefore, maintaining levels of ac tivity may enhance functional capacity and role performance towards improving patients perception of hea lth status and QOL. This study further calls for effective mana gement of fatigue symptoms experienced during the immediate period follo wing stem cell transplant. 7

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An earlier study by Harder et al. (2002) considered fatigue a main disease and treatment related predictor for cognitive im pairment. Harder and colleagues examined the cognitive functioning and quality of lif e in long-term adult survivors of bone marrow transplant 22 to 82 months post tr eatment. The sample was comprised of 40 disease-free patients treated with SCT for hematological malignancies, 87% of whom had undergone an allogeneic transplant. A battery of neuropsychological tests was used to assess the mental status and cognitive performance of the subjects. For QOL and mood states measurement the EORTC QLQ-C30 and the brief version of the Profile of Mood States (POMS) were utili zed. POMS measures five dimensions of general psychological distress: depression, tension, anger, fatigue, and vigor. The authors found mild to moderate cognitive impairment in 60% of the subjects, especially in the areas of verbal learning, visual memo ry, selective attention and information processing speed. A substantia l correlation was found between cognitive impairment and fatigue symptom on both EORTC QLQC30 (r= 0.55; p <0.001) and POMS scales (r=0.51, p < 0.001). A significant relations hip was also found between fatigue, cognitive functioning and physical functioning. QOL and fatigue were significantly associated with depression measured by POMS. Fatigue remains a challenge for SCT patients even years after transplant. The findings of this study indicate that fatigue can predict late cognitive deficits in long term survivors. The authors reported that neuropsychological impairments and cognitive complaints were associated with increased absence from work and school. With such decreases in functional status, pa tients may experience role dissatisfaction and a reduction in quality of life. Clinicians mostly attribute fatigue to the nature of the cancer illness and the treatment regimens. However, it is not we ll understood why fatigue persists long after 8

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treatment completion when the patients ar e disease free or in complete remission years after the transplant. Mo st recently in the Netherlands, Gielissen et al. (2007) explored this phenomenon of post SCT persiste nt fatigue in light of the precipitating and perpetuating theoretical model. The aut hors identified five perpetuating factors that influence the persisten ce of fatigue symptoms which include insufficient coping, fear of disease recurrence, cognitive dysfunction, sleep di sturbance and dysregulation of activity. In a cross-secti onal retrospective design, ninety-eight survivals of acute myeloid or lymphatic leukemia, chronic myeloid leukemia and non-Hodgkins lymphoma who received autologous and allogeneic SCT between 1981 and 2003, participated in the study. All patients had to be in persistent complete remission for at least one year after SCT, those with graft-versus-hos t disease (GVHD) grade III and IV or with hemoglobin of 10 g/dl and lowe r were excluded. This was done in order to make the sample less prone to fatigue th an the general populati on of SCT. Several instruments were used to evaluate the pr evalence of each of th e perpetuating factors identified. Fatigue was measured using the fatigue severity subscale of the Checklist Individual Strength (CIS). A CIS fatigue sc ore equal to or higher than 35 identified severe fatigue. Even long after receiving SCT (mean= 9.3 years) thirty-four patients (35%) met the criteria of severe fatigue and 12% had heightened fatigue scores. The data analysis revealed a very low non-si gnificant correlation between fatigue scores and the length of hospital st ay during transpla ntation. The correlation between CIS fatigue scores and time since transplantation, which ranged from 1 to 15 years, also proved to be low and non-significant. Patients with comorbidities such as hypertension, diabetes, infections and hepatitis C were found to have higher levels of fatigue (Gielissen et al., 2007). The author s also concluded that the perpetuating model explained and highly predicted the severity and the persistence of fatigue, 9

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suggesting that several psychosocial factors, rather than medical factors, were mostly associated with persistent fatigue. Anderson et al. (2007) assessed sympto m burden of patients during the acute phase of autologous transplant. The purpos e of their study was to determine the severity of the symptoms experienced by pa tients and to identify predictors of high levels of symptom burden. The authors hypothesized that symptom intensity and related interference would increase post transp lant and be most severe at nadir. The sample consisted of 100 patients with mu ltiple myeloma or non-Hodgkins lymphoma undergoing autologous stem cell transplanta tion with matched conditioning regimens for each group. Assessment was carried out at baseline before commencing conditioning regimen, on the third to four th day of the conditioning regimen, on the day of transplantation, on the day of na dir and on 30 days post-transplant. The subjects were asked to complete the bl ood and marrow transplantation module of the M. D. Anderson Symptom Inventory (MDASI-BMT), a measure of symptom severity and symptom related interference in daily life, and the Eastern Cooperative Oncology Group Performance Status (ECOG PS), whic h measures functional status, at each time point. Mood and quality of life were measured on baseline and on day 30 posttransplant using the Profile of Mood States (POMS) and the Functional Assessment of Cancer TherapyBone Marrow Transplant (FACT-BMT) scales (Anderson et al., 2007). The authors reported that over half of the patients complained of moderate to severe fatigue which interfered mostly with general activity, mood, walking, and enjoyment of life. The mean scores of symptom severity and symptom interference were significantly greater at nadir compared with baseline levels. Fatigue along with symptoms of weakness, feeling physically sick, disturbed sleep, nausea and vomiting showed the highest intensities The severity of fatigue had a significant correlation 10

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( p= 0.049) between the time point and the diagnosis. Patients with non-Hodgkins lymphoma reported higher levels of fatigue at baseline, on nadir, and on 30 day posttransplant compared to the patients with multiple myeloma. Anderson et al. (2007) related this difference among these two groups to differences in the disease physiology or treatment history and conditi oning regimens. Clinicians can help optimize symptom management, as they b ecome aware of the different symptoms burden and pattern associated with the different diagnoses of SCT population (Anderson et al., 2007). Another research study addressing th e symptom burden by Bevans, Mitchell and Marden (2008) was aimed at describing the symptom ch aracteristics experienced in the post transplant period. Seventy-six adult patients with hematologic disorders undergoing their first matched related alloge neic SCT enrolled in this study. Data were utilized from a prospective study of health-related quality of life (HRQL) in which the participants were already enro lled. Symptom occurrence, distress, and clusters were measured using the Symp tom Distress Scale (SDS). Based on the 11 symptoms of nausea, appetite change, insomnia, pain, fatigue, bowel changes, concentration, appearance, worry (outlook), breathing, and cough; each symptom is rated on a 6-point Likert-type scale. Sy mptom distress was indicated as mild, moderate, or severe. To be considered clustered, symptoms had to at least be moderately and significantly related to one another and si multaneously independent of other SDS symptoms (Bevans et al., 2008). Medical Outcom es Short Form 36 Health Survey (SF-36 version 1) also was used to measure functional health and well being. Data were collected on baseline before conditioning commencement and on days 0, 30, and 100 after allogeneic SCT. Bevans a nd colleagues reported that fatigue was among the most prevalent symptoms acro ss study time points. Fatigue was reported 11

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by 68% of participants at baseline, 86 % of participants on day zero, 90% of participants on day 30 and 81% of particip ants at day 100 post-transplant. Fatigue occurrence was also prevalent in symptom cl usters. At baseline, the most prevalent symptom cluster was fatigue and worry. On days 0 and 30 the symptom cluster consisted of fatigue, bowel change, and insomnia. Fatigue symptom distress was reported by six patients (11%) at day 100, but no symptom cluster was noted. The authors suggested that the ex tent of symptom distress, prevalence, and occurrence of fatigue in clusters emphasizes the importa nce of tailoring interventions to target fatigue according to the phase of recover y. Fatigue symptom distress predicts poor functional recovery, general health, and quality of life. Managing symptom distress may provide SCT population with an opportunity for better outcomes (Bevans et al., 2008). Quality of Life In a prospective study by Hjermstad et al (2004), health related quality of life (HRQOL), fatigue, anxiety, and depressi on were assessed in 248 patients with hematological or lymphocytic malignancies, following treatment SCT. The purpose of the study was to describe the fluctuations of those symptoms and HRQOL of the patients over a period of three years or mo re after completion of transplant, while comparing assessment scores between a llogeneic SCT and autologous SCT groups with patients who received conventiona l chemotherapy (CT) alone. The EORTC QLQ-C30 questionnaire was utilized by the authors, is a 30-item tool which incorporates five functional sc ales (physical, role, emotiona l, cognitive, and social); a three symptom scales measuring fatigue, pain and nausea and vomiting; one scale assessing overall health/g lobal QOL; and six single items to assess symptoms commonly reported by cancer patients such as dyspnea, sleep disturbances, appetite 12

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loss, diarrhea, constipation and financial impact. The EORTC QLQ-C30 was administered nine times throughout the three-year study period. Measurement of physical and mental fatigue was assessed by the Fatigue Questionnaire (FQ). The FQ asks questions about fatigue symptoms e xperienced during the last month compared with how the subjects felt when they were well. Anxiety an d depression symptom distress was measured using the Hospital Anxiety and Depressi on Scale (HADS). At baseline, a marked difference wa s found between allogeneic SCT and autologous SCT patients on the fatigue sy mptom scale and global QOL scores. The allogeneic SCT group experienced less fatigue and better quality of life at baseline, but greater impairment than autologous SC T patients on second week post transplant with an increase in fatigue symptoms and reduction in functional levels. Gradual improvement in symptomatolgy occurred at 4 to 8 months until levels returned to baseline at one year. In comparison, the autologous SCT group showed less fluctuation from the baseline scores and a more rapid recovery, as global QOL scores became similar to baseline or even bette r after four months only. The CT group showed a negative change in global quality of life after 4 to 6 months of treatment, where scores stabilized at a level signifi cantly higher than baseline (Hjermstad et al. 2004). The authors reported that despite that early recovery of the autologous SCT group they were found to report poorer func tioning and more fatigue at three years after transplant. No statistically signifi cant difference was reached for physical and mental FS scores, yet more autologous SCT patients reported chronic fatigue when compared to allogeneic SCT group, CT pa tients and the general population. There was no significant change in depression or anxiety scores across all groups. The authors also suggested that this pronounced impairment in QOL and the chronic 13

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fatigue complaints of ASCT group, may be attributed to the ex tensive chemotherapy and radiation those patients re ceived prior to transplant These findings emphasize the importance of HRQOL assessment of stem ce ll transplantation recipients with focus on functional status and fatigue symptoms. It is also important to advise patients to maintain a close follow up with their health care providers to optimize the hospital to home environment transition (Hjermstad et al. 2004). Schulmeister, Quiett, and Mayer (2005) e xplored the quality of life, quality of care, and patients satisfaction with outpatie nt autologous stem ce ll transplant (ASCT) experience. Forty adult patients undergoi ng ASCT were interviewed via telephone, three times, over a six-month period. To measur e Quality of life, subjects were asked to complete the Functional Assessment of Cancer TherapyBMT (FACT-BMT) scale during interviews at 4 to 6 weeks after chemotherapy and again at six months post chemotherapy. The FACT-BMT scale measures five dimensions of QOL including: physical, social/family, emotional, f unctional well-being, and BMT effects. Telephone interviews guided by open-ended ques tions were used to explore patients ASCT experiences and satisfaction with the outpatient ASCT process (Schulmeister et al., 2005). The authors found that patients who reported negative previous healthcare experiences had significantly lower scor es on the emotional well-being subscale. Those who had progressive disease showed lower QOL and significantly more regret for having the transplant. Concentration and memory problems, which interfered with work, household responsibilities, leisure ac tivities, and interpersonal relationships, were experienced by 22% of the patients. FACT-BMT scores were lowest one month post treatment and were highe st six months post transpla nt. Higher QOL and greater satisfaction with care were associated w ith good clinical outcomes following ASCT. In general, the majority of the patients ha d reported a positive outpatient experience. 14

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Although some of the patients reported that the outpatie nt ASCT experience did not feel personalized, they complained that the recommendations for self care and symptom management booklets, which they received in outpatient clinic, did not address their personal concerns and needs. Many complained that important treatment related issues such as: sexuality and fert ility issues, complementary and alternative therapies, and long term side effects were underemphasize d. Patients expressed a need for more information on how to maintain th eir strength and activity tolerance, fatigue, and skin problems management. They also expected post transplant psychosocial support to be offered for patients and families which could have further improved their quality of life (S chulmeister et al., 2005). One of the strengths of this study wa s that it included both qualitative and quantitative research methods. The findings indicate the value of constructing individualized interviews with patients where clinicians can personalize the experience of SCT and address the most re levant concerns for each individual. The SCT experience is faced with much uncertain ty and thus, as these authors suggested, the nurses should consider providing speci fic care plans including specific dietary suggestions and exercise prescriptions. Ongoing evaluation of the survivors needs and concerns would enhance patients sati sfaction with the SCT experience and help optimize the associated quality of life. Summary In summation, research has found that SCT related fatigue worsens in the acute post transplant period along with the quality of life (El-Banna et al., 2004; Hacker et al., 2006; Anders on et al., 2007). Many differi ng phenomena are associated with fatigue in post SCT individuals. Th ese phenomena could be physiological with effects on strength, sleep pattern, and physical activity (Hjermstad et al., 2004), or 15

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they could be cognitive, perceptual, motivatio nal or psychological in nature (Harder et al., 2002). Higher levels of fa tigue symptoms distress have been predictive of poor quality of life, poor general health, greater emotional distress, and overall mortality (Gielissen et al., 2007; Schulmeister et al., 2005). Proper assessment of the fatigue dimens ions is essential in combating this condition. Clinicians should be able to identify fatigue symptom distress in each phase of recovery (Bevans et al., 2008) and design appropriate individualized interventions with personalized patient education plans (Schulmeister et al., 2005). Most of the available litera ture on fatigue in stem cell transplant population focused on the acute recovery period. The current study is proposed to expand the knowledge base related to fatigue inte nsity, fatigue symptom distress, and their relationship with quality of life of long term adult surv ivors at least 5 months post stem cell transplantation. 16

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Chapter III Methods This chapter presents the research met hods and procedures that were used in this study. First the sample selection and setting are described. Second, methods of measurement including description of th e Instruments with their validity and reliability are discussed. Third, research procedures are described including the data collection methods. Finally the data analysis plan is di scussed. This descriptive, exploratory study used a cross sectional design to describe the relationship between fatigue symptom distress and quality of life (QOL) in stem cell transplant (SCT) survivors. Setting and Sample The research data were collected at Moffitt Cancer Center, a National Cancer Institute (NCI) designated comprehensive ca ncer center in southwest Florida. The target population for this study was adult SCT survivors who were at least six months following completion of SCT procedures including chemotherapy, total body irradiation therapy and stem cells transfusi on. Inclusion criteria in cluded: (1) being an adult over 18 years of age at the time of tr ansplant, (2) incomplete or partial remission of underlying disease, (3) being able to read and understand English, and (4) willingness to participate in the study. Exclusion criteria for this sample included (1) active cancer treatment with chemotherapy, ra diation, or immunotherapy in the past 6 months, (2) hospitalization at the time of the study, (3) a history of chronic fatigue syndrome, fibromyalgia, or any comorbidity related fatigue history, and (4) a current 17

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psychiatric diagnosis or neurol ogical deficit that may impe de the subjects ability to comprehend the study. A sample of 50 adult BMT outpatients was sought. Instrumentation Three Instruments were used for this study, (1) The Cancer Related Fatigue Distress Scale (CRFDS), (2) The Functi onal Assessment of Ca ncer Therapy-Bone Marrow Transplant (FACT-BMT) version 4, and (3) a Demographic Data/Health Information Form. Cancer Related Fatigue Distress Scale The Cancer Related Fatigue Distress Scale (CRFDS) was used to collect data on fatigue symptom distress (Appendix A) The summated rating scale of 20 items addresses cognitive, physical, psychological, social and spiritual distress The CRFDS items have similar stem and response struct ure. Each item begins with: The fatigue or tiredness I am having causes me distress because it... followed by an item from distress categories (e.g., Makes me too tired to eat ). The study participants were asked to rate their distress on an 11-poin t scale, ranging from 0 (no distress) to 10 (severe distress). The CRFDS scores are based on how the subject has felt over the last week, therefore, lending itself to a more accurate reporting of ones overall fatigue distress experience. The total possibl e scores of the scale ranges from zero to 200, the higher the score, the greater the level of fatigue symptom distress. The CRFDS also includes three 0-10 fatigue inte nsity scales that measure "fatigue now" "usual fatigue in the past wee k," and "worst fatigue in the past week. Zero represents no fatigue and ten as the most severe fatigue. The participants' performance status was measured using the Karnofsky Performance Status (KPS) Scale, to determine the participants' ability to perform daily activities (Holley, 2000). 18

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Validity and Reliability. The CRFDS has strong content validity and high reliability. The items of this scale were constructed from 23 audio taped interviews with 17 patients who experienced cancer re lated fatigue (CRF). Patients input in developing the scale supported its construct validity. Fact or analysis was used to assess construct validity which confirmed a ll items loaded on one factor, indicating that all items assessed CRF distress. Usi ng a conservative standard of 0.70, 20 of the 23 items met the standard and were reta ined. Factor loadings ranged from 0.5890.913. The measure also has shown signi ficant pre to post score changes ( p <0.001). Reliability for internal consistency estim ate of this measure is very high, with coefficient alpha of 0.98 (Holley, 2000). Functional Assessment of Cancer TherapyBone Marrow Transplant The Functional Assessment of Cancer TherapyBone Marrow Transplant (FACTBMT) is a 39-item scale that meas ures five dimensions of QOL in BMT recipients including: physical (7 items), soci al/family (7 items), emotional (6 items), functional (7 items) well-being and a 12 item BMT-subscale. BMT specific items were designed to assess QOL content sp ecific to the BMT process (Appendix B). Patients are asked to rate themselves on how they feel today and over the past 7 days. A 5-point Likert-type scale is used to rate each item of the questionnaire from 0 (not at all) to 4 (very much). Higher scores are associated with higher levels of satisfaction with QOL. The total scores for the FACT-BMT can range from 0. The FACTBMT was further expanded to include 23 items in the BMT subscale, resulting in FACT-BMT (Version 4) which more specifica lly measures the unique effects of BMT on QOL Items that were added to the subscal e included ability to concentrate, ability to remember things, experiencing blurry ey esight, experiencing frequent colds or infections, noting food taste changes, ha ving tremors, experiencing shortness of 19

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20 breath, having skin problems, experiencing bow el trouble, illness hardship on family members, and the cost of treatment (M cQuellon et al., 1997). These items are considered experimental, with ongoing psyc hometric evaluation a nd currently are not included in the scoring. This data was not reported. Respondents burden of this 50items scale is considered minimal as the av erage time to completion is 5-10 minutes (McQuellon et al., 1997). Validity and Reliability. The FACT-BMT underwent a three-step validation process which involved testing of overall measures with subscales correlation and internal consistency calculations. Items of BMT subscale were selected from a list produced by seven oncology experts and 15 pa tients which enhances its construct validity. The BMT subscale demonstrated sensit ivity to change over time at baseline, post-transplant, upon discharge and 100 days post transplant (McQuellon et al., 1997). Coefficients of reliability and validity fo r the entire scale ar e high. The authors found no significant difference between autologous or allogeneic SCT patients, or patients with Graft Versus Host Disease (GVHD) compared to those without GVHD. This supports more generalizability of this tool for the BMT population. Demographic Data/Health Information form Demographic and personal characteristics of the subjects were collected using the Demographic Data/Health Information Form (Appendix C). The data included in this form are: age, gender, ethnicity, educational background, marital status, and employment status. Questions were asked about underlying cancer diagnosis, type of transplant received and months from transplant completion, status of their cancer, and whether they received any cancer treatment in the past 6 months. These data were used to determine whether type of transplant and/or time from transplant influence the experience of persistent fatigue.

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Procedures Approvals The principle investigator was respon sible for assuring the research was implemented safely and effectively in accordance with the regulations of the Institutional Review Board (IRB) of the Univ ersity of South Florida. Before obtaining the research approval of IRB, a behavioral research application was filed with the Scientific Review Committee of MCC. The benefit-risk ratio was assessed for this study, indicating the study design had minimal ri sk to subjects and important benefits. Informed consent (Appendix D) was designe d to be easily unde rstood and contained no coercive language. Upon approval of MCC (Appendix E) the proposal was submitted to IRB. Approval letter was obtai ned from IRB (Appendix F) along with approved consent stamped with I RB approval and expiration date. Data Collection A research flyer was used to advertise the study and was distributed around the BMT outpatient clinic, treatment center, and the clinic waiting areas at MCC. The Principle investigators (P I) phone number was provided in the flyer for interested individuals to contact and inquire about the study. The healthcare providers and support staff of BMT clinic also identified pot ential participants, initiated the contact, and referred them to the study. Upon visiti ng the outpatient clinic for scheduled BMT follow up appointments, patients met with the PI and the study was explained. If patients agreed to join the study, they completed a screen ing form which determined their eligibility to participate. The PI assessed potential participants using the inclusion/ exclusion criteria. When sample criteria were met, written consent to participate was collected from patients and a copy of the signed informed c onsent was given to the participants to 21

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keep. Patients participating in other MCC fatigue or qual ity of life studies were not asked to participate. Participants were ta ken to a private consult room, the study was explained to them, and they were instructed on how to complete the three questionnaires. Subjects we re given the opportunity to ask questions about the research and the PI was available in the area for clarification. Forms were reviewed for completeness of response, staff and patients were thanked for their participation. Data were gathered from 33 subjects. The raw data collected and original consent forms were stored in a locked file drawer in the principle investigators locked office and will be kept for five years after completion of study and then shredded. Data Analysis Descriptive statistics were performed for all variables. Tests were two-sided and a p value of 0.05 or less was considered stat istically significant. All data were analyzed using the Statistical Package for Social Sciences (SPSS) for windows version 18 software. Demographic data were reported with frequencies, percentages, means, standard deviations, and ranges; which are presented in the sample characteristics table (Table 1). The research questions provi ded direction for this data analysis. For research question #1: What is the prevalence of fatigue and the level of fatigue symptom distress reported by cancer patients at l east six months past completing SCT? The mean ratings of each item on the CRFDS were used to evaluate the levels of fatigue Intensity and fatigue distress described by the participants. Similarly, for research question #2: What do patients report th eir quality of life to be at least six months after SCT? Mean quality of life scores of FACT-BMT were calculated overall and among subscales. 22

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For research question #3: Is there a significant rela tionship between fatigue symptom distress and quality of life of cancer patients at least six months after SCT? Pearsons correlation coefficient (r) was utilized. Similarly, for research questions 4 and 5, the Pearson correlation was used to assess the association between time from tr ansplant and fatigue symptom distress and quality of life. 23

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Chapter IV Results, Discussion and Conclusion The following chapter presents the findings of this study. First, the sample is described. Next, the research questions are addressed. The results, strengths and limitations of the study are discussed. The chapter also includes recommendations for nursing practice, nursing edu cation, and nursing research. Results Sample Thirtynine (n = 39) BMT outpatients were approached to participate in the study. Four declined participat ion due to feeling tired, and thirty-five (n = 35) agreed to participate. Two of the completed questionnaires were discarded for incomplete information. Twenty-one males and 12 fema les participated in this study (N = 33) (Table 1). The mean age was 53 (SD = 9.79) with a range between 36 and 70 years. Of the 33 participants, 24 (73%) were ma rried, 5 (15%) were single, 3 (9%) were divorced, and 1 (3%) was widowed. A majority of the patients were Caucasian (79%), followed by Hispanic (15%), and African Am erican (6%). Seventy-six percent (n = 25) of the recipients receiv ed allogeneic stem cell transplantation and the remainder underwent autologous SCT (n = 8). The mean length of time from transplant for surviving patients was 19.24 months (S D = 17.78; range = 6 months, n = 33). Among the participants the most frequen tly occurring diagnoses were non Hodgkins lymphoma (24%), followed by acute myeloid leukemia (21%), and acute lymphocytic leukemia (18%) (Table 2). 24

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Table 1 Demographics and Clinical Characteristics of Patients Variable Frequency Percentages Gender Male 21 64 Female 12 36 Race/ethnicity Caucasian 26 79 Hispanic 5 15 African American 2 6 Education 0 2 6 High school 10 30 Some college 11 33 College graduate 8 24 Post graduate 2 6 Marital status Married 24 73 Single 5 15 Separated/divorced 3 9 Widowed 1 3 Occupational status Disability/unemployed 15 45.4 Employed 13 39.4 Retired 5 15.2 25

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Table 2 Diagnoses and Type of Transplant Variable Frequency Percentages Diagnosis Non-Hodgkin lymphoma 8 24.2 Acute myeloid leukemia 7 21.2 Acute lymphocytic leukemia 6 18.2 Multiple myeloma 5 15.2 Myelodysplastic syndromes 3 9.2 Chronic lymphocytic leukemia. 1 3 Chronic myeloid fibrosis 1 3 Chronic myeloid leukemia 1 3 Small Cell Lung Carcinoma 1 3 Type of transplant Allogeneic 25 76 Autologous 8 24 Fatigue Intensity and Symptom Distress Research question 1: What is the pr evalence and level of fatigue distress reported by cancer patients at least six months past completing SCT? Thirty-one participants (93.9%) reported persistent fatigue and five (15%) rated their fatigue 10 out of 10 at its worst. The mean value of current fatigue reported by allogeneic transplant participants was 2.56 (SD= 2.33), and mean= 2.38 (SD= 1.69) for the autologous transplant subjects, for both groups combined the mean was 2.52 (SD= 2.17). The mean usual fatigue of all partic ipants was 2.85 (SD= 1.97), for allogeneic transplant participants the mean usua l fatigue was 2.84 (SD= 2.07) and 2.88 (SD= 1.73) for autologous transplant participants. The mean worst fatigue for all subjects 26

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was 4.79 (SD= 3.07), 4.56 (SD= 3.09) for alloge neic transplant pa rticipants and 5.50 (SD= 3.07) for autologous tran splant participants (Table 3). The ratings of CRFDS were summed for each participant, the total scores ranged from 0, with a mean value of 61.8 (Table 4). Table 3 Means, Standard Deviations and Ranges of Fatigue Intensity Scores Variable n Minimum Maximum Mean SD KPS scale 33 50 100 85 13.5 Total Fatigue intensity Usual 33 0 7 2.85 1.97 Current 33 0 8 2.52 2.17 Worst 33 0 10 4.79 3.07 Allogeneic Usual 25 2.84 2.07 Current 25 2.56 2.33 Worst 25 4.52 3.09 Autologous Usual 8 2.38 1.69 Current 8 2.88 1.73 Worst 8 5.50 3.07 Note. n= number of subjects, SD= Standard Deviation. Research question 2: What do patients report their quality of life to be at least six months after SCT? Total scores of th e FACT-BMT ranged from a minimum of 57 and a maximum of 145 with the mean of 113.78 (Table 4). 27

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Table 4 Means, Standard Deviations, and Ranges of Total Scores of CRFDS and FACT-BMT n Minimum Maximum Mean SD CRFDS total 33 0 169 61.89 50.82 FACTBMT total 33 57 145 113.78 25.66 Relationship between Fatigue Symptom Distress and QOL Research question 3: Is there a si gnificant relationship between fatigue symptom distress and quality of life of cancer patients at least six months after SCT? Pearsons product-moment correlation coefficient (r) was used to calculate the relationship between the total scores of fatigue symptom distress levels from CRFDS and the total scores of QOL from FACT -BMT. A strong negativ e correlation (r= -.86, p <.0001) was found, which was statisti cally significant (Table 5). Relationship between Fatigue Sympto m Distress and Time from Transplant Research question 4: Is there a signi ficant relationship between fatigue and time from transplant? To assess the associ ation between time from transplant and fatigue symptom distress, Pearsons produc t-moment correlation coefficient (r) was used. A moderate positive relationship was found between CRFDS total and the time from transplant (r= .46, p = .007). This finding was statistic ally significant (Table 5). Relationship between QOL and Time from Transplant Research question 5: Is there a significant relationship between quality of life and time from transplant? The Pearson correlation coefficient was used to examine the relationship between QOL and time fr om transplant. A moderate negative correlation was found (r= -.34, p=.052) which did not reac h statistical significance (Table 5). 28

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Table 5 Pearson Correlation Coefficients between Fati gue Symptom Distress, Quality of Life, and Time from Transplant Fatigue Symptom Distress Quality of Life Variable n r p n r p Quality of life 33 -.86 <.0001 33 1 ___ Time from Transplant 33 .46 .007 33 -.34 .052 Discussion Sample In this study, a convenience sample of 33 men and women was accrued at the comprehensive cancer center MCC. When the participants came to the BMT clinic for post transplant follow up visits they met with the PI and completed the consent form meeting all institutional, state, and federal guidelines. They also completed the CRFDS and FACT-BMT with an attached demographic data form. The tools took approximately 20 minutes to complete. A minimal respondents burden is of a particular importance when measuring fatig ue in individuals w ho may already have attentional deficits, lack of energy, and feelings of tiredness. A limitation of the sample is that it di d not represent the SC T types accurately for the BMT population. The majority of the participants underwent allogeneic stem cell transplant, and only ei ght of them had autologous SCT. In addition, although participation criteria were nonexclusive of ethnicity groups or racial backgrounds, minorities were not well represented in this sample. There were also more men than women participants. Strength of the samp le is the diversity of the underlying diagnosis which included eight differe nt types of cancer, which is a good representation of the SCT population. 29

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Fatigue, Symptom Distress, and Quality of Life This study identified that fatigue is widely prevalent among BMT long term survivors; approximately 93% of the subj ects experience some degree of fatigue according to the fatigue intensity scale of CRFDS. The literature reviewed in this study supports this finding. Gielis sen et al. (2007) reported that side effects of BMT often precipitate heightened levels of fati gue. In this study, 5 participants (15%) rated their fatigue 10 out of 10 at its worst. This finding is in agreement with the assumption that patients with more aggressive treatments such as BMT are more at risk for persistent fatigue. The CRFDS to tal scores ranged from 0, with a mean of 61.8. The mean of fatigue symptom dist ress is considered somewhat low. A possible explanation for the inconsistency be tween the literature reviewed and this study finding is the diversity of underlying di agnoses and the difference in the type of BMT. Also, it should be considered that CRFDS measures the distress and suffering that accompanies the experi ence of fatigue symptom. Although fatigue symptom was quite prevalent among the participants, fatigue intensity can occur in variable levels that are not necessarily altogether distressful. In this study, the majority of patient s (76%) received allogeneic SCT. Those who received autologous transplant (24%) reported less fatigue symptom distress with mean= 48.0 (SD= 36.62), compared to th e allogeneic transplant group (mean= 66.2, SD= 54.49). Although this difference did not reach statistical significance ( p = 0.71) it is considered clinically significant. A possible explan ation of this difference is that autologous SCT patients underwent a shorter hospital stay during transplant, had fewer complications and had no risk for GVHD compared to allogeneic transplant patients. In this sample of patients it was also found that fatigue symptom distress in allogeneic transplant subjects have been more severe. Harder et al. (2007) also related 30

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that to their exposure to acute and chr onic GVHD and other compli cations related to immunosuppression or immunosuppressive therapy. However, this finding should not distract from the fact that some autologous transplant participants did report fatigue symptom distress which should still be addressed on individual bases. The total FACT-BMT scores rang ed from 57-145. The mean score was 113.78. This study found moderate levels of QOL. Schulmeister, Quiett and Mayer (2005) reported that higher QOL and greater satisfaction were associated with good clinical outcomes following transplant though there were lingering fatigue effects. Gielissen et al. (2007) also reported that fatigue persis ts long after treatment had ended. Relationship between Fatigue Symptom Distress and QOL A strong significant negative corr elation (r= -.85, p <.0001) was found between reported levels of fatigue symp tom distress and QOL in this sample. The greater the levels of fatigue symptom dist ress, the poorer the quality of life. This negative correlation was an expected finding, and it supports the idea that persistent fatigue has a detrimental consequence on QOL of BMT long term survivors. However, a correlational study does not conf irm cause and effect. This study supports the findings of Hjermstad et al. (2004) who reported an inverse relationship between fatigue, cognitive or social function and QOL. Relationship between Time from Transplant, Fatigue Symptom Distress and QOL A significant moderate positive correlation was found between CRFDS total scores and the time from transplant (r= .46, p= .007). This correlation may be precipitated by emotional rath er than physical distress; that is, those who had the longest survival seemed mo re distressed by fatigue. This relationship may occur because they expected a resolution of their symptoms and a sooner return to 31

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normalcy. For patients closer to the time of transplant, there is reason to be hopeful that fatigue symptoms will fade away when they return to their normal functional levels and regain th eir full strength. A moderate negative relationship wa s found between QOL and time from transplant, supporting th e idea that lingering fatigue doe s affect the quality of life. Although a shorter time from transplant corr elated with higher QOL levels (r= -.34, p=.052) this finding did not reac h statistical significance. It should also be noted that the most well-functioning transplant patients completed the questionnaires, while the most ill, most fatigued patients declined participation. Approximately 10% of these patients stated upon request that they did not feel well, they felt tired, and that was why they did not want to take part in the study. The failure of these patients to participate might have biased the st udy results in some important ways. Conclusions Implications for Nursing This study supports the importance of a ddressing fatigue symptoms in patients who have undergone BMT as a possible a pproach to improving overall QOL. The study findings reflect that approximately 93% of the particip ants in this study experience some degree of fatigue after tran splant. Also, it demons trated a significant negative relationship between fatigue symptom distress and quality of life. This is relevant to nursing care and patient educa tion. It would be highly advisable to inform the patients prior to transplant of the poten tial of developing some persistent fatigue that they may find to be di stressing. The consequences of this can be diminished functional capacity which is of particular concern with pati ents ability to maintain or return to their productive roles in society (Hacker et al. 2006). Therefore, it is equally important to maintain levels of activity to enhance functiona l capacity and role 32

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performance towards improving patients perception of health status and QOL. Understanding the relationship between fa tigue symptom distress and QOL should encourage interdisciplinary collaboration in planning proper interventions to minimize fatigue. This would improve the outcomes of BMT long term survivors and would positively impact their overall quality of life. Implications for Research A limitation of this study is that the patients with the worst BMT experience probably were not accessible because of th eir fatigue. Future studies with larger sample size should evaluate the specific chem otherapeutic agents or dosages used in BMT conditioning protocols and determine whether they impact the occurrence, frequency and persistence of fatigue. Sim ilarly, the cross secti onal design of this study lacks pre-treatment base line assessment which precl udes definite conclusions about a change in fatigue and QOL over time. A longitudinal cohort study using a comprehensive psychosocial test to inves tigate the effects of BMT treatment on the QOL of adult long term survivors is warranted. 33

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References American Cancer Society (2009). Bone Marrow and Peripheral Blood Stem Cell Transplants. Retrieved from h ttp://www.cancer.org/docroot/ETO/eto_1_3 _Bone_Marrow.asp Anderson, K., Giralt, S., Mendoza, T., Brown, J., Neumann, J., Mobley, G., . Cleeland, C. (2007). Symptom burden in patients undergoing autologous stemcell transplantation. Bone Marrow Transplantation 39(12), 759-766. Bevans, M., Mitchell, S., & Marden, S. ( 2008).The symptom experience in the first 100 days following allogeneic hematopoietic stem cell transplantation (HSCT). Support Care Cancer, 16 (11), 1243. El-Banna, M., Berger, A., Farr, L., Foxall, M., Friesth, B., & Sc hreiner, E. (2004). Fatigue and depression in patients wi th lymphoma undergoing autologous peripheral blood stem cell transplantation. Oncology Nursing Forum, 31 (5), 937-944. Frick, E., Borasio, G., Zehentner, H., Fischer, N., & Bumeder, I. (2004). Individual quality of life of patients undergoing autologous peripheral blood stem cell transplantation. Psycho-Oncology 13: 116-124. Gielissen, M., Schattenberg, A., Verhagen, C., Rinkes, M., Bremmers, M., & Bleijenberg, G. (2007). Experience of se vere fatigue in long-term survivors of stem cell transplantation. Bone Marrow Transplantation, 39 (10), 595-603. Hacker, E., Ferrans, C., Verlen, E., Ravandi, F., Besien, K., Gelms, J., & Dieterle, N. (2006). Fatigue and physical activity in patients undergoing hematopoietic stem cell transplant. Oncology Nursing Forum, 33 (3), 614-624. Harder, H., Cornelissen, J., Gool, A., Duivenvoorden, H., Eijkenboom, W., & Bent, M. (2002). Cognitive functioning and qua lity of life in long-term adult survivors of bone marrow transplantation. Cancer, 95(1), 183-192 Hjermstad, M., Knobel, H., Brinch, L., Fayers, P., Loge, J., Holte, H., & Kassa, S. (2004). Quality of life: A prospective study of health-related quality of life, fatigue, anxiety and depression 3 years after stem cell transplantation. Bone Marrow Transplantation 34(3), 257-266. Holley, S. (2000). Evaluating patient dist ress from cancer-related fatigue: An instrument development study. Oncology Nursing Forum, 27 (9), 1425-31. 34

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Luctkar-Flude, M., Groll, D., Tranme r, J., & Woodend, K. (2007). Fatigue and physical activity in older adults with cancer. Cancer Nursing 30(5), E35-E45 McQuellon, R., Russell, G., Cella, D., Crave n, B., Brady, M., Bonomi, A., & Hurd, D. (1997). Quality of life measurement in bone marrow transplantation: Development of the Functional Assessme nt of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone MarrowTransplantation, 19(4), 357368. Mitchell, S., Beck, S., Hood, L., Moore, K., & Tanner, E. (2007). Putting evidence into practice: Evidence-based interven tions for fatigue during and following cancer and its treatment. Clinical Journal of Oncology Nursing, 11 (1), 99-113. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: Cancer related fatigue, v1.2008. Retrieved from http://www.nccn .org/professionals/physic ian_gls/PDF/fatigue.pdf. Schulmeister, L., Quiett, K., & Mayer, K. (2005). Quality of life, quality of care, and patient satisfaction: Perceptions of patients undergoing outpatient autologous stem cell transplantation. Oncology Nursing Forum, 32(1), 57-67. 35

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Appendices 36

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Appendix A: Cancer Related Fa tigue Distress Scale (CRFDS) CANCER RELATED FATIGUE DISTRESS SCALE (CRFDS) Sandra Holley, PhD, ARNP Instruction: Below and on the next 3 pages is a list of problems people sometimes have because of their cancer related fatigue. Please read each one carefull y. Please circle the number that best describes HOW MUCH THAT PROBLEM HAS DISTRESSED OR BOTHERED YOU DURING THE PAST 7 DAYS INCLUDING TODAY. Circle only one number for each problem and do not skip any items. If you change your mind, erase your first mark carefully. Read the example before beginning, and if you have any questions please ask them now. Please complete all 20 items and the 3 additional items on the last page The fatigue or tiredness I am having causes me distress because it : 1. Makes it difficult for me to concentrate. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 2. Makes me feel that I must accept more help from others. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 3. Makes me feel that I am more than just tired. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 4. Makes me feel frustrated when I cant do what I used to do. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe dis tress 5. Makes my body feel as though it doesnt want to function. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 37

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Appendix A (Continued) The fatigue or tiredness I am having causes me distress because it : 6. Makes it difficult for me to form whole thoughts. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 7. Makes me feel like my phys ical abilities are being worn away. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 8. Makes me feel that I am still tired after sleeping. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 9. Makes me feel guilty when I cant do the things that are my usual jobs to do. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 10. Makes me too tired to eat. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 11. Makes me limit my family and social activities. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 12. Makes me feel tired more quickly than typical fatigue. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 38

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Appendix A (Continued) The fatigue or tiredness I am having causes me distress because it : 13. makes me feel uncertain about my future. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 14. Makes me feel totally exhausted. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 15. Makes me feel like I am a different person. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 16. Makes me stay at home more. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 17. Makes me feel a loss of control over my life. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 18. Makes it difficult for me to remember things. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 19. Makes me feel as if I have no energy. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress 39

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Appendix A (Continued) The fatigue or tiredness I am having causes me distress because it : 20. Makes me feel like I am losing interest in things. How much distress does this cause you? 0 1 2 3 4 5 6 7 8 9 10 No distress Severe distress Please circle the number that most describes your fatigue. No fatigue Severe fatigue Fatigue level now 0 1 2 3 4 5 6 7 8 9 10 Worst fatigue level this past 7 days 0 1 2 3 4 5 6 7 8 9 10 Usual fatigue level for the past 7 days 0 1 2 3 4 5 6 7 8 9 10 Please circle the one number below that best describes your situation now KARNOFSKY PERFORMANCE SCALE 100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity; minor signs of symptoms of disease 80 Normal activity with effort; some sign or symptoms of disease 70 Cares for self; unable to carry on normal activity or do active work 60 Requires occasional assistance, but is able to care for most personal needs 50 Requires considerable assistance and frequent medical care 40 Disabled; requires special care and assistance 40

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Appendix B: Functional Assessment of Ca ncer TherapyBone Marrow Transplant (FACT-BMT) Below is a list of statements that other people with your illness have said are important Please circle or mark one numb er per line to indicate your response as it applies to the past 7 days PHYSICAL WELL-BEING Not at all A little bit Some what Quite a bit Very much I have a lack of energy 0 1 2 3 4 I have nausea 0 1 2 3 4 Because of my physical condition, I have trouble meeting the ne eds of my family 0 1 2 3 4 I have pain 0 1 2 3 4 I am bothered by side effects of treatment 0 1 2 3 4 I feel ill 0 1 2 3 4 I am forced to spend time in bed 0 1 2 3 4 SOCIAL/FAMILY WELLBEING Not at all A little bit some what Quite a bit Very much I feel close to my friends 0 1 2 3 4 I get emotional support from my family 0 1 2 3 4 I get support from my friends 0 1 2 3 4 My family has accepted my illness 0 1 2 3 4 I am satisfied with family communication about my illness 0 1 2 3 4 I feel close to my partner (or the person who is my main support) 0 1 2 3 4 41 Regardless of your current level of sexual activity, please answer the following question. If you prefer not to answer it, please mark this box and go to the next section. I am satisfied with my sex life 0 1 2 3 4

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Appendix B (Continued) Please circle or mark one number per line to indicate your response as it applies to the past 7 days EMOTIONAL WELL-BEING Not at all A little bit Some -what Quite a bit Very much I feel sad 0 1 2 3 4 I am satisfied with how I am coping with my illness 0 1 2 3 4 I am losing hope in the fight against my illness 0 1 2 3 4 I feel nervous 0 1 2 3 4 I worry about dying 0 1 2 3 4 I worry that my condition will get worse 0 1 2 3 4 FUNCTIONAL WELL-BEING Not at all A little bit Some -what Quite a bit Very much I am able to work (include work at home) 0 1 2 3 4 My work (include work at home) is fulfilling 0 1 2 3 4 I am able to enjoy life 0 1 2 3 4 I have accepted my illness 0 1 2 3 4 I am sleeping well 0 1 2 3 4 I am enjoying the things I usually do for fun 0 1 2 3 4 I am content with the qu ality of my life right 0 1 2 3 4 42

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Appendix B (Continued) Please circle or mark one number per line to indicate your response as it applies to the past 7 days ADDITIONAL CONCERNS Not at all A little bit Some what Quite a bit Very much I am concerned about keeping my job (include work at home) 0 1 2 3 4 I feel distant from other people 0 1 2 3 4 I worry that the transplant will not work 0 1 2 3 4 The effects of treatment are worse than I had ima g ine d 0 1 2 3 4 I have a good appetite 0 1 2 3 4 I like the appearance of my body 0 1 2 3 4 I am able to get around by myself 0 1 2 3 4 I get tired easily 0 1 2 3 4 I am interested in sex 0 1 2 3 4 I have concerns about my ability to have children 0 1 2 3 4 I have confidence in my nurse(s) 0 1 2 3 4 I regret having the bone marrow transplant 0 1 2 3 4 I can remember things 0 1 2 3 4 I am able to concentrate 0 1 2 3 4 I have frequent colds/infections 0 1 2 3 4 My eyesight is blurry 0 1 2 3 4 I am bothered by a change in the way food tt 0 1 2 3 4 I have tremors 0 1 2 3 4 I have been short of breath 0 1 2 3 4 I am bothered by skin problems (rash, itching) 0 1 2 3 4 I have trouble with my bowels 0 1 2 3 4 My illness is a personal hardship for my close famil y members 0 1 2 3 4 The cost of my treatment is a burden on me or my family 0 1 2 3 4 43

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Appendix C: Demographic Data/Hea lth History Information Form Part A: Demographic data 1. Age___ (Please, do NOT provi de your date of birth) 2. Gender: Male ____ Female ____ 3. Ethnicity/Race (check one) ___ American Indian/Alaska Native ___ Arab American ___ Asian American/Pacific Islander ___ Black/African American ___ Caucasian/White/Anglo ___ Hispanic/Latino ___ Other 4. Educational background___________________ (Highest grade completed) 5. Marital status: Single ___ Married ___ Widowed ___ Separated ___ Divorced___ 6. Employment status: ___ Self employed ___ Employed outside the house ___ Disability ___no ___ yes, specify: ________________________________ Part B: Health History Information Underlying Cancer diagnosis: _______________________________________ Type of Transplant received: (Check one) ___ Bone Marrow Transplant ___ Blood/Stem Cell Transplant ___ Cord Blood ___ Allogeneic Transplant (from a dono r) ___ Autologous Transplant (from self) Number of months from Transplant completion ______ Are you in complete or partial remissi on? Complete ___ Partial___ I dont know__ 44

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Appendix D: Informed Consent 45

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Appendix D (Continued) 46

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Appendix E: Moffitt Cancer Center Scientific Review Committee approval August 14, 2009 Suzan Abduljawad H. Lee Moffitt Cancer Center & Research Institute University of South Florida 12902 Magnolia Drive Tampa, FL 33612 Dear Ms. Abduljawad: The Behavioral Subcommittee of the Sc ientific Review Committee (SRC) has reviewed your response for your research protocol entitled, Fatigue Symptom Distress and Its Relationship with Qu ality of Life in Adult Stem Cell Transplant Survivors (MCC 16029). The revised protocol version dated 08/11/2009 is approved as written for use at the Moffitt Cancer Center pending approval of the Institutional Review Boar d (IRB) and satisfaction of institutional operational and financial review requirements. Please be aware that after you receive IRB approval, you must request study activation before you commence any study activities. The Protocol Review and Monitoring System will ensure that all applicable institutional reviews have been completed. You will then be issued an activation letter. Upon receipt of the activation letter, you will be able to conduct your study. It is your responsibility to ensure that all Moffitt staff (nursing, pharmacy, data management, etc.) is informed and aware of the details of the project. The committee encourages the use of in-services for those projects that are complex or require special attention. All changes made to protocols approved by the SRC must be submitted to the Protocol Review and Monitoring System. Changes made to the protocol document require SRC review and approval. Minor changes (i.e. changes to personnel, non-scientific changes, changes that do not affect patient participation) will be expedited through the SRC review process. If this project is not bei ng managed by the Clinical Trials Office or Clinical Research Unit, then it is your responsibility to follow through with all requirements for submission to the IRB. All IRB approvals are required to be documented in Oncore, and all associated regulatory documentation (signed applications, IRB approval letters and IRB approved consent forms, etc.) are to be saved in the appropriate study folder in the e-binders directory at J:\ebinders. Oncore is the Cancer Centers mechanism for required submission and review of materials requiring IRB review as well as items requiring review by the Scientific 50

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Appendix E (Continued) Review and Protocol Monitoring Committees. If you are not currently reporting the necessary research activities, such as patient accrual, changes in procedure, adverse events and continuing reviews in Oncore, please contact Jeryl Madden, Oncore Coordinator, at 745-6964 for direction. Sincerely, Paul Jacobsen, PhD Chair, Behavioral Subcommittee Scientific Review Committee 51

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52 Appendix F: Institutional Review Board Approval DIVISION OF RESEARCH INTEGRITY AND COMPLIANCE Institutional Review Boards, FWA No. 00001669 12901 Bruce B. Downs Blvd., MDC035.Tampa, FL 33612-4799 (813) 974-5638FAX (813) 974-5618 September 3, 2009 Suzan Abduljawad College of Nursing Tampa FL 33612 RE: Expedited Approval for Initial Review IRB#: 108313 I Title: Fatigue Symptom Distress and its Effect on Quality of Life in Adult Stem Cell Transplant Survivors Study Approval Period: 08/31/2009 to 08/30/2010 Dear Ms. Abduljawad: On August 31, 2009, Institutional Review Board (IRB) reviewed and APPROVED the above protocol for the period indicated above It was the determination of the IRB that your study qualified for expedited review based on the federal expedited category number five (5) and seven (7). Approval included with the Moffitt Adult Informed Consent Form. Please note, if applicable, only use the IRB-Approved and stamped consent forms for participants to sign The enclosed informed consent/ assent documents are valid during the period indicated by the official, IRB-Approval stamp located on page one of the form. Make copies from the enclosed original. Please reference the above IRB protocol number in all correspondence regarding this protocol with the IRB or the Division of Research Integrity and Compliance. In addition, you can find the Institutional Review Board (IRB) Quick Reference Guide providing guidelines and resources to assist you in meeting your responsibilities in the conduction of human participant research on our website. Please read th is guide carefully. It is your responsibility to conduct this study in accordance with IRB policies and procedures and as approved by the IRB. We appreciate your dedication to the ethical conduct of human subject research at the University of South Florida and your conti nued commitment to human research protections. If you have any questions regarding th is matter, please call 813-974-2036 Sincerely, Krista Kutash, Ph.D., Chairperson USF Institutional Review Board Cc: Various Menzel/cd, USF IRB Professional Staff Susan McMillan PhD