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Hockett, Keri Ann.
The effects of a comprehensive post-treatment recovery program for breast cancer survivors
h [electronic resource] /
by Keri Ann Hockett.
[Tampa, Fla.] :
b University of South Florida,
Thesis (Ph.D.)--University of South Florida, 2005.
Includes bibliographical references.
Text (Electronic thesis) in PDF format.
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Mode of access: World Wide Web.
Title from PDF of title page.
Document formatted into pages; contains 96 pages.
ABSTRACT: Background: Breast cancer and its treatment often result in side effects that persist long after treatment has ended. The increased survival rate for breast cancer has allowed for the study of the physical and psychosocial symptoms that persist into the post-treatment period. Although research has tested various interventions and demonstrated improvement in some symptoms, no standard of care exists for management of symptoms in the post- treatment period as part of the continuum of care.Objective: The aim of this research was to examine the effects of a comprehensive recovery program of education, exercise, and support for breast cancer survivors and to compare the results to a control group.Method: This experimental study used a convenience sample of 17 women who participated in a structured breast cancer recovery program over a 10-week period, and compared them to a control group of 13 survivors who did not participate in a structured program over a 10- week period.Data were collected on demographic and personal characteristics, extent of disease, and type of treatment. The two subject groups were compared on their self-report responses of physical and social functioning as measured by the SF-36[copyright], their level of distress from fatigue as measured by the Cancer Fatigue Related Distress Scale, and their degree of uncertainty as measured by the Mishel Uncertainty in Illness Scale. The subjects completed these self-reports at three time points: week 1, week 5, and week 10.Results: There were no significant demographic differences between the experimental and the control group. Repeated measures ANOVA demonstrated significant differences over time in the experimental group on all measures, except for the physical functioning scale which was approaching significance at p=.06, but no significant differences over time in the control group on any of the measures.
Adviser: Susan C. McMillan.
t USF Electronic Theses and Dissertations.
The Effects of a Comprehensive Post-Treatme nt Recovery Program for Breast Cancer Survivors By Keri Ann Hockett A dissertation submitted in partial fulfillment of the requirement for the degree of Doctor of Philosophy College of Nursing University of South Florida Major Professor: Susan C. McMillan, Ph.D. Lois O. Gonzalez, Ph.D. Linda E. Moody, Ph. D. Brent J. Small, Ph.D. Date of Approval: July 25, 2005 Keywords: breast cancer, exercise fatigue, support, uncertainty Copyright 2005, Keri A. Hockett
For Stevie Â“Follow in my wake You've not that much at stake For I have plowed the seas And smoothed the troubled waters Come along let's have some fun The hard work has been done We'll barrel roll into the sun Just for startersÂ” Jimmy Buffet Barometer Soup
Acknowledgements I wish to acknowledge with my sincerest gratitude the members of my dissertation committee. Dr. Susan McMillan, Committee Chair and my mentor these last 15 years, I am privileged to have been under your guidance and extraordinary mentorship throughout this process. Thank you for the in itial challenge and th e support to see me through it. Dr. Linda Moody for opening my mind the ve ry first day of doctoral classes and showing me every day what being a distinguished scholar means. Dr. Lois Gonzalez, for your thoroughness, thoughtful critique, and insight in reviewing my manuscript. Your comm ents and support were most sincerely appreciated in developing a writing style. Dr. Brent Small, who has the wisdom of Solomon and patience of Jobthank you for your statistical expertise and guidance w ith data analysis. Thank you for always making time to see me or speak with me. I must also thank Tricia Holtje for he r assistance with the IRB application process, and give a huge thank you to Melis sa Leggatt who made herself available to assist me so many times. I consider myself so very blessed to ha ve studied with each and every one of you.
i Table of Contents List of Tables iii List of Figures iv Abstract v Chapter One Introduction 1 Problem Statement 5 Hypotheses 6 Definition of Terms 6 Significance to Nursing 8 Summary 8 Chapter Two Review of the Literature 9 Uncertainty 10 Exercise & Physical Activity 13 Exercise and Fatigue 17 Conceptual Framework 18 Summary 20 Chapter Three Method Research Design 21 Sample and Setting 21 Instruments 23 Medical Outcomes Study Short Form-36 23 Scoring 23 Validity and Reliability 23 Cancer Related Fatigue Distress Scale 24 Validity and Reliability 24 Mishel Uncertainty in Illness Scale 24 Validity and Reliability 25 Procedures 25 Approvals 25 Intervention 25 Data Collection 26 Data Analysis Plan 26
ii Chapter Four Results 29 Profile of the Sample 29 Experimental Group 29 Control Group 31 Comparison of Experimental and Control Groups 32 Physical, Social Functio ning and Vitality 32 Uncertainty 35 Cancer Related Fatigue Distress 37 Chapter Five Discussion 39 Physical and Social Functioning and Vitality 39 Uncertainty in Illness 40 Cancer Fatigue Related Distress 41 Limitations of the Study 42 Sample 42 Method 43 Generalizability 43 Recommendations for Future Research 44 Conclusion 45 References 46 Appendices Appendix A: Consent to Participate in the Return to Wellness Program 53 Appendix B:Personal History Form 56 Appendix C:Sample Return to Wellness Schedule 58 Appendix D:Instruments 62 Appendix E: Institutional Review Board Approval 78 Appendix F: Informed Consent 80 Appendix G: Invitation to Participate 84 About the Author End Page
iii List of Tables Table 1 Sample Composition 30 Table 2 Descriptive Statistics by Group for PF, SF and VT Scales 33 Table 3 Physical Functioning: Main Effects and Interaction Effect 33 Table 4 Social Functioning: Main E ffects and Interaction Effect 34 Table 5 Vitality: Main Effects a nd Interaction Effect 34 Table 6 Physical Function: Main Effect of Time by Subject 35 Table 7 Social Function: Main Effect of Time by Subject 35 Table 8 Vitality: Main Effect of Time by Subject 35 Table 9 Descriptive Statistics for the Mishel Uncertainty in Illness Scale 36 Table 10 Uncertainty: Main Effect s and Interaction Effect 36 Table 11 Uncertainty: Main Effect of Time by Subject Group 37 Table 12 Descriptive Sta tistics by Group for the Ca ncer Related Fatigue Distress Scale 38 Table 13 Cancer Related Fatigue Distress: Main Eff ects and Interaction Effect 38 Table 14 Cancer Related Fatigue Di stress Main Effect of Time by Subject Group 38
iv List of Figures Figure 1. Conceptual Model 19
v The Effects of a Comprehensive Post-Treat ment Recovery Program for Breast Cancer Survivors Keri Ann Hockett ABSTRACT Background: Breast cancer and its tr eatment often result in side effects that persist long after treatment has ended. The increased survival rate for breast cancer has allowed for the study of the physical and psychosocial symp toms that persist into the post-treatment period. Although research has tested va rious interventions and demonstrated improvement in some symptoms, no standard of care exists for management of symptoms in the posttreatment period as part of the continuum of care. Objective: The aim of this research was to examine the effects of a comprehensive recovery program of education, exercise, a nd support for breast cancer survivors and to compare the results to a control group. Method: This experimental study used a convenience sample of 17 women who participated in a structured breast cancer recovery progr am over a 10-week period, and compared them to a control group of 13 survi vors who did not participate in a structured program over a 10week period. Data we re collected on demographic and personal characteristics, extent of di sease, and type of treatment. The two subject groups were compared on their self-report responses of phys ical and social functioning as measured by the SF-36, their level of distress from fatigue as measured by the Cancer Fatigue Related Distress Scale, and their degree of uncertainty as measured by the Mishel
vi Uncertainty in Illness Scale. The subjects completed thes e self-reports at three time points: week 1, week 5, and week 10. Results: There were no significant demographi c differences between the experimental and the control group. Repeated measures ANOVA demonstrated significant differences over time in the experimental group on all m easures, except for the physical functioning scale which was approaching significance at p=.06, but no significant differences over time in the control group on any of the meas ures. Conclusion: The Return to Wellness program was effective in improving social f unctioning and vitality in women with breast cancer who completed the program. It was al so effective in reducing uncertainty and distress associated with cancer related fatigue.
1 Chapter One Introduction Breast cancer is the most commonly occu rring cancer in women in the United States. Approximately 200,00 women are diagno sed with breast cance r annually (2005). Advances in screening, early detection, and newer treatments have led to an increased overall five-year survival rate that approaches 87%, and is much higher for early stage, localized disease (National Cancer Institute 2003). These advances in breast cancer treatment mean that many more women are alive today than ever before due to the increased survival rate. As more and more women are cured of thei r disease, the number of breast cancer survivors in th e general population continues to climb, and thus we learn more about the long-term sequelae of treatme nt and the issues of survivorship. The current standard of care for the tr eatment of breast cancer can include any combination of surgery, chemotherapy, radi ation therapy, biotherapy, hormonal therapy, and most recently, targeted ther apies with monoclonal antibodies. The type of treatment prescribed depends on the stage of the diseas e, the histological characteristics, and the presence or absence of hormonal receptors and growth receptors. The physical condition of the woman and her menopausal status also is considered. Each treatment has its own unique set of side effects and potential complications that often require additional therapies to manage them. When combined, these treatments may act synergistically to eradicate the cancer cells, but at the same time they may serve to intensify adverse side effects and symptoms. There may also be differences in symptom burden among age
2 groups and by type of treatment (Cimpric h, 1992; Greene, Nail, Fieler, Dudgeon, & Jones, 1994). Findings indicate that as women complete thei r physical treatments, they experience side effects that linger long after treatment has ended (Jacobsen et al., 1999). The most commonly experienced physical a nd psychological symptoms are fatigue, pain, sleep disturbances, weight gain, anxiet y, cognitive impairment, depression, and uncertainty about cancer recurrence and deat h (Jacobsen et al., 1999; Mishel, Padilla, Grant, & Sorensen, 1991). In addition, breas t cancer patients have described an altered sense of femininity, and decrea sed physical attractiveness. Mo reover, the side effect of lymphedema may develop and continue beyond the treatment period (Brady et al., 1997). Fatigue is consistently identified in the li terature as the symptom most bothersome to breast cancer patients and is the one of longest duration (J acobsen et al., 1999; Longman, Braden, & Mishel, 1997). The persisten ce of any one of these symptoms can significantly prolong a less than optimal leve l of functioning for these women. These symptoms and their associated problems can continue months to years after the completion of treatment, effectively altering patterns of adjustment and adaptation, and therefore inhibiting the retu rn to optimal functioning a nd well being (Spiegel, 1997). Decreased social and physical levels of functioning can have profound economic implications, resulting in the inability to retu rn to work or to perform prior social roles and responsibilities adequatel y. Upper-body limitations, advan ced disease, and working in jobs requiring manual physical activity have been associated with the need for longer medical leave time (Satariano & DeLorenze, 1996). In addition, systemic chemotherapy as part of past treatment has been found to be a predictor of poorer qua lity of life in long term survivors of breast can cer (Ganz et al., 2002).
3 The role of psychosocial support has demons trated positive results in facilitating adjustment and adaptation during and after treatment for cancer. Support groups have been instrumental in improving psychosocia l functional levels for breast cancer survivors. Upon completion of treatment many women have e xpressed a sense of abandonment coinciding with no l onger visiting the clinic or the physician (Dow, Ferrell, Haberman, & Eaton, 1999). Concerns a bout cancer recurrence do not necessarily diminish with length of time out from dia gnosis or completion of treatment (Holzner et al., 2001; Polinsky, 1994). The types of support groups studied have included open-ended support groups, self-help groups, and educationa l or cognitive-behavior al interventions. All these types of support groups have been shown to improve coping abilities, mastery, and to decrease stress, promote hope, improve quality of life, and decrease symptom distress, including distress from fatigue and uncertainty (Burish & Tope, 1992; Cella & Yellen, 1993; Enbright & Lyon, 2002; F obair, 1997; Ream & Richardson, 1999). Cimprich (1999) found identifiable patterns of symptom distress in women with breast cancer prior to beginning trea tment, suggesting the need to begin interventions toward adjustment much sooner. The role of physical rehabi litation in overcoming the phys ical deconditioning that occurs specifically among breas t cancer survivors has only b een explored over the last decade. The recent surge in the number of physical rehabilitation programs aimed at breast cancer survivors coincides with the advances in treatment and the increased survival rate. Published studi es report that such interven tions improve overall physical functional capacity, enhance quality of life, and reduce levels of fatigue (Mock et al., 1997; Schwartz, 2000b; Winningham, MacVicar Bondoc, Anderson, & Minton, 1989).
4 The form of physical rehabilitation used most often for this purpose is an exercise-based program. Research has not been consistent regard ing the initiation of exercise programs, therefore, the place for a formal posttreatmen t exercise or rehabil itation program as part of the continuum of breast cancer care and recovery is yet to be defined. While pulmonary rehabilitation programs, lymphe dema programs, and general physical rehabilitation programs exist for facilitating adaptation to specific physical alterations, no clear published evidence exists regarding de fined treatment parameters for assisting women in adapting to the physical and psychosoc ial issues of breast cancer survivorship. It is now known that breast cancer treatment often leads to weight gain, and studies have revealed that an increased body mass index is as sociated with an incr ease in breast cancer recurrence and increased mortality rate from the disease (Brown et al., 2003). This suggests a need to investigate ways to mi nimize or reverse weight gain from breast cancer treatment. Physical rehabilitation efforts, however, can be limited by anemia and low platelet counts which in crease risk for bleeding, nausea, and pain (Beck, 2003). Severe peripheral neuropathies which can in terfere with balance, and osteoporosis as a result of treatments that induce menopause and decrease bone mineral density may also inhibit physical interventions (Swenson, 2005; Wampler, 2005). The Return to Wellness program is a 10week program of physical exercise, education, and psychosocial support designed to help women adjust to survivorship. It was developed by The Wellness Communit y, a national not-for-profit organization dedicated to improving the quality of lif e in cancer survivors through psychosocial support and education. The Wellness Community serves only people affected by cancer
5 as well as their significant others. All support groups at The Wellness Community are facilitated by professionals, most of whom are licensed clin ical psychologi sts, licensed clinical social workers, and licensed mental health counselor s. All services are provided free of charge. There are more than 20 separate centers of The Wellness Community throughout the United States. The Wellne ss Community operates under the Â“Patient ActiveÂ” concept, which stresses that, through support and education, patients and their significant others can be empowered to actively take part in their treatment and recovery. The Wellness Community believes that active patient participation in treatment and recovery reduces emotional and psychological distress, particularly aloneness, loss of control, and loss of hope. The Wellness Commu nity offers support, education and other programs such as Return to Wellness as a wa y to reduce these stre ssors. (J. Kleinbaum, personal communication, March 5, 2004). The Wellness Community partners with other local community agencies in its area, such as hospitals, to offer the physical exercise portion of the Return to Wellness program. Problem Statement The first Return to Wellness program was a partnership between The Wellness Community San Francisco and a hospital in sout hern California. The Return to Wellness training manual states that the purpose of Return to Wellness is to help Â“women with breast cancer acquire important information a nd support for life after treatment so that they may recover from the physical and emotiona l effects of breast cancer treatment more fully and more quicklyÂ” (page 2). No formal goals or objectives have been written from which to develop the program, and no eval uative data have been published. An unpublished report on the Return to Wellness p ilot program does state that there were
6 small but significant reductions in mild to moderate depression on the Geriatric Depression Scale. Also reporte d were small reductions in bo dy fat, small weight losses, and small improvements in strength, flexibilit y, endurance, and cardiov ascular fitness. No statistical or demographic information is provi ded to substantiate this information. Other than naming the Geriatric Depression Scale, no instruments or methods are described for measuring the reported outcomes from the pilot program (Kraemer, 2001). The purpose of this study is to measure the effects of the Return to Wellness program, a structured program of physical ex ercise, education, and psychosocial support, on women who have completed treatment for breast cancer. Hypotheses The hypotheses to be test ed in this study are: Women treated for breast cancer who complete the Return to Wellness program will: 1. report significantly improved physical func tioning, social functioning and vitality compared to a control group as reported on PF, SF and VT scales of the SF-36. 2. have significantly lower scor es on the Mishel Uncertainty in Illness Scale (MUIS) compared to a control group. 3. report significantly less distress from fati gue on the Cancer Related Fatigue Distress Scale (CRFDS) compared to a control group. Definition of Terms For the purpose of this study, the following terms are defined: Uncertainty according to Mishel and Braden, (1987), uncertainty is a cognitive state that occurs when a person cannot assign meaning or structure to a particul ar situation because cues are not present. For breast cancer surv ivors, the actual outcome is not known for
7 certain, and information may be lacking re garding cure, recurrence, and prognoses for various side effects and conditi ons Uncertainty also can be linked to a lack of social support, a lack of education, or a lack of a credible author ity. Credible authority means trust and confidence in one Â’s health care provider. Cancer-related fatigue distresscancer re lated fatigue is defined by the National Comprehensive Cancer Network (NCCN) as Â“a persistent, subjective sense of tiredness related to cancer or cancer tr eatment that interferes with usual functioningÂ” (Mock et al., 2000) It is a multidimensional, subjective sy mptom that has physiological, emotional psychological and spiritual aspect s. It is prevalent in up to 100% of patients who receive chemotherapy and in up to 93% in patients w ho are treated with ra diation therapy. It remains a bothersome symptom in up to 40% of cancer survivors (Broeckel, Jacobsen, Horton, Balducci, & Lyman, 1998; Ream & Ri chardson, 1999) According to Holley (2000b), cancer related fatigue di stress is the suffering that is a consequence of cancer related fatigue. Deconditioningmany of the self-care strategies that patients use to alleviate or minimize fatigue actually worsen the fatigue. The mo st common practice among patients is to rest, nap, or sleep more (Richardson & Ream, 1997) This actually contributes to further physical deconditioning. Physical deconditioning is defined as the process whereby the bodyÂ’s ability to perform work is decreased in response to less and less demand over a period of time. The body therefore adju sts to a decreased level of functioning (Winningham, 1996).
8 Significance to Nursing Currently there are no evidence-based guidelines for nursing regarding the standard for education, intervention and ev aluation for the woman recovering from a breast cancer diagnosis upon comp letion of treatment. Eviden ce-based clinical research can assist in identifying the interventions most likely to be successful in assisting women to adjust effectively to survivorship, a nd achieve optimal physical and psychosocial functioning after a breast cancer diagnosis and treatment. Th is research is a beginning step toward that process. The informati on gained from this study may generate new knowledge that nurses and other health care prov iders can use to better articulate the role of structured rehabilitation programs. It also may help to define program content and format, and formulate expected outcomes fo r the woman recovering from breast cancer, and may demonstrate that th e continuum of care extends beyond completion of the prescribed treatment period. Summary Chapter one discusses the physical and psychosocial implications of a breast cancer diagnosis and treatment, and how these effects linger well into the post-treatment phase of survivorship. No formal evidence-b ased guidelines exist to define the standard of care for women in this transition, and th e currently defined continuum of care does not adequately extend beyond the conventional tr eatment phase. An exploratory research study is proposed to determine if an existi ng structured program of exercise, education and support will be effective in improving physi cal and social functioning, lessen feelings of uncertainty, and relieve di stress from fatigue associated with cancer treatment.
9 Chapter Two Review of the Literature This chapter presents a synthesis of th e literature related to the concepts of uncertainty and fatigue related distress, as well as self-help inte rventions to improve physical and social functioning th at were tested with breast ca ncer survivors. In addition, studies related to education, s upport, and physical interventions such as exercise and yoga with breast cancer survivors are reviewed. An electronic search of four databases (Medline, Proquest, Ovid, and CINAHL) wa s conducted to identify the pertinent literature printed in English and published from January 1993 to May 2005. Keywords for the search were: breast cancer, rehabi litation, survivorship, fatigue, uncertainty, psychosocial, distress, exercise, recovery, support, education, yoga, complementary, and integrative. The searches using these keywords produced 173 articles. Additional studies were located through ancestry search of pr eviously acquired articles and reports. In 2004, the Institute of Medicine and the National Research Council produced a report called Meeting the Psychosocial Needs of Women with Breast Ca ncer (2004). This report estimates that approximately one-thir d of all breast cancer patients experience psychosocial distress, and that risk factors associated with distress are younger age, preexisting mental illness, physical comorbidities, sexual difficulties, and lack of social support
10 Uncertainty Uncertainty is a cognitive state that occu rs when a person is unable to assign meaning or structure to an event (Mis hel & Braden, 1987). Upon completion of treatment, many women with breast cancer ex perience a heightened sense of uncertainty related to no longer needing regimented care in the form of freque nt visits to their physician and clinic staff. The completion of treatment can signify th e transfer of their care back to their primary care physician and the loss of regular reassurance from their cancer care providers (Institute of Medicine & National Research Council, 2004). According to McCormick, (2002) one of th e problems in defining and describing uncertainty is the inability to separate it as an isolated concept from the situationassociated emotions that provoke it. Th e completion of breast cancer treatment can leave women with a sense of foreboding about thei r future. This degree of uncertainty is further compounded by the fear of recurren ce (Holland & Rowland, 1991). Ill-prepared to deal with the lingering physical and psyc hosocial effects of the disease and/or its treatment, breast cancer survivors entering th e post-treatment phase often find themselves questioning the meaning of their symptoms a nd the validity of their level of concern (Rowland & Massie, 1998). Mishel (1990) has theorized that uncerta inty in chronic illness is mediated by social support, education, and credible au thority. Numerous studies have been undertaken to test these concepts for their ut ility as effective medi ators in facilitating psychosocial adjustment. In particular, the impact of social support in reducing distress has been studied extensively. Social suppor t consists of both emotional support and instrumental support (Finfgeld-Connett, 2005). Emotional support involves comforting
11 and consoling a person in order to reduce un certainty, anxiety, and stress (Jankowski, Videka-Sherman, & Laquidara-Dickinson, 1996; Sandstrom, 1996). Emotional support does not have to involve a physical presence on the part of the s upport person, but rather can exist in the form of cards and letters telephone calls and more recently, through the internet (Gurowka & Lightman, 1996; Prudhoe & Peters, 1995; Tichon & Shapiro, 2003). Instrumental support involves providing goods and services such as transportation, food, housekeeping and physical care (Finfgel d-Connett, 2005; Gilliland, 2001; Gurowka & Lightman, 1996). According to Finfgeld-Conne tt, (2005), patients pr efer that social support come from non-professionals. Dirksen (2000) conducted a study that de monstrated social support to be the strongest predictor of higher self-esteem and well-being in breast cancer survivors, while uncertainty was found to be a negative predicto r of resourcefulness. Similar results were found in a study of younger breast cancer survivors by Sammarco (2001) where study findings supported the positive relationship be tween social support and quality of life, and a negative correlation between uncertain ty and social support, and also between uncertainty and quality of life in breast can cer survivors under age 50. The results also demonstrated a positive relationship between social support and the size of the support network. The majority of studies that examine prevalence and mediators of distress in breast cancer survivors are cross-sectional an d/or focus only on the initial post-treatment period (Helgeson, Snyder, & Seltman, 2004). There are however, a handful of studies that examine distress in breast cancer patients at more than one point in time, or further beyond the immediate post-treatment period. One su ch study of survivors five to nine
12 years post-treatment identified triggers of uncer tainty as hearing about some elseÂ’s cancer and having new aches and pains (Gill et al., 200 4). In examining ch aracteristics of risk for psychological distress in breast cancer survivors at one year post diagnosis, Schag et al. (1993) found that high risk for psychol ogical distress was ba sed upon a history of depression, significant physical or psychological stressors pr ior to or during diagnosis and treatment, or having serious econo mic, vocational or marital problems. In a study of survivors at three mont hs and 12 months after surgery for breast cancer, it was found that social support becomes critical late r in the post-operative period, and that the need for social support conti nues as the time out from surgery increases (Enbright & Lyon, 2002). In a study of couples breast cancer patients and their partners completed four inventories at six different time periods from the immediate post-surgical period to one year. Emotional adjustment wa s predicted by marital support, other social support, and role function, while social role functioning was pr edictive of physical adjustment (Hoskins et al., 1996). The Self-Help Intervention Project was a large study conducted by Longman, Braden, and Mishel to test three interventions consisting of a self-help course, uncertainty management, or a self-help course plus uncer tainty management. All three interventions were shown to be effective in increasi ng self care and psychological adjustment, especially in women who demonstrated low resourcefulness (Braden, Mishel, & Longman, 1998; Longman, Braden, & Mishel, 1996; Longman et al., 1997; Longman, Braden, & Mishel, 1999). The role of education in th e form of videotape, tele phone counseling or education with telephone counseling has demonstrat ed significant improvement in physical,
13 emotional, and social adjustment (Longma n et al., 1997, 1999). The effectiveness of educational audiotapes was further found to increase self-care behaviors in women undergoing treatment for breast cancer (Williams & Schreier, 2004), Similar results were found by Lev and Owen (2000) in a study of a counseling intervention consisting of videotape, booklet and traine d nurse counselor se ssions at regular intervals. Findings suggested that the interventi ons were useful for improving quality of life and reducing distress. Exercise and Physical Activity In the last decade, there has been a surg e in the amount of research examining the role of physical activity in the primary prevention of br east cancer as well as the prevention of recurrence. Since the mid-1990s studies have shown modest reduction in the initial incidence of breast cancer in women who engage in a higher level of physical activity (McTiernan, 2000; Patel, Callel, Bernstein, Wu, & Thun, 2003; Pritchard, 2004). More recently, there has been an increased focus on the role of physical activity and exercise in extending survival and reducing the rate of r ecurrence after a breast cancer diagnosis (Enger & Bernstein, 2004; Holmes, 2005) In addition, the role of physical activity has been studied to determine when and how often it is used to test for its effects on quality of life, physical f unctioning, fatigue, and sympto m burden in both short and long term survivors, and in wo men who are still under treatment Because the effects of physical exercise take time to become eviden t, most studies of the effects of exercise interventions in breast can cer survivors are l ongitudinal, and employ both observational as well as interven tional study designs.
14 The national Centers for Disease Contro l and Prevention (CDC) has established recommendations for physical activity for American adults. These recommendations state that adults should engage in moderate physical activity for at least 30 minutes for a minimum of five times per week. Alternatel y, if engaging in vigorous physical activity, then 20 minutes or more at least three tim es per week is reco mmended (Department of Health and Human Services Centers for Disease Control and Prevention/American College of Sports Medicine, 2005). Few resear chers, however, utilize or incorporate this operationalized definition into the method of their studies. One of the exercise strategies used in the Return to Wellness Program is physical conditioning through strength training with resistance bands. Strength training with either bands or free weights has been shown to be effective in increasing bone mineral density and strength, reducing body fat, in creasing muscle-to-fat ratio, and boosting metabolism (Galvao & Newton, 2005; Kasper, 2004). According to the CDC (2005), strength training also has been found to impr ove balance, reduce risk of falls, improve glucose control, help maintain body weight, and improve the quality of sleep The other exercise method employed in the Return to Wellness program is yoga. Yoga has been shown to improve physical functioning and social well-being while also decreasing fatigue in breast cancer survi vors undergoing treatment (Moadel, 2003). It also has been shown to improve overall quality of life decrease symptom distress, and enhance immune function (Carlson, Speca, Patel, & G oodey, 2003). It should be noted that there are many anecdotal references to the use of yoga as a complementary therapy in many cancers, but very little rigorous scientific evidence is currently published. This is a
15 relatively new area of research in the wester n hemisphere. Scientific studies that are published demonstrate that yoga has been useful in improvi ng aerobic capacity in healthy adults and those with asthma, and mood improvement in healthy adult students (Manocha, 2003; Netz & Lidor, 2003; Ray et al., 2001). Both yoga a nd strength training are considered to be forms of moderate physical activity by the both the CDC and the American College of Sports Medicine (D epartment of Health and Human Services Centers for Disease Control and Prevention/Am erican College of Sports Medicine, 2005). A longitudinal study of exerci se behaviors in breast ca ncer survivors found that those women who did participate in exercise did not increase the amount of their exercise over time, and at all measurement time points all of the women were exercising below the recommended level of minutes of exercise. Among those who did exercise, there was a reported increase in physica l functioning, but no improvement in mood or symptoms (Irwin et al., 2004; Pinto, Maruyama et al., 2002) Similar results were found in a study by Blanchard et al. (2003) th at demonstrated breast cancer survivors engage in as much exercise as controls, though they participate in different activ ities than controls, but still below the government recommendations. In a long-term study of br east cancer survivors who were on average, eight years post-surge ry, it was found that, compared to baseline measures, decreases in physical and social functioning persist well pa st the initial post treatment phase (Polinsky, 1994). These fi ndings were supported by a study of upperbody strength in breast cancer survivors that revealed self-report ed upper-body functional limitations are greater than age-matched controls and persist well into the post-treatment period. At one year, the greatest improve ment was seen in the youngest age groups (Satariano & Ragland, 1996). Even with such ev idence, the literature has yet to yield any
16 rigorous studies that examine the prevalen ce and effects of a sustained, long-term program of exercise. It is important to understand the factor s affecting a breast cancer survivorÂ’s motivation to exercise and willingness to adhere to an exercise program. One such factor is physician support (Knols, Aaronson, Uebe lhart, Fransen, & Aufdemkampe, 2005). Breast cancer patients initiate exercise si gnificantly more when their oncologist has recommended they exercise (Jones, C ourneya, Fairey, & Mackey, 2004). Other determinants of initiation and adherence include intention, extraversion, support from significant others, perceived control, exercise preferences and past exercise history, level of fatigue, co-morbidities, and younger ag e (Courneya, 2003; Courneya, Blanchard, & Laing, 2001; Pinto, Trunzo, Reiss, & Shiu, 2002; Rhodes, Courneya, & Bobick, 2001). Similar findings were supported in study by R ogers (2004) that also supported time management and social networking as determ inants of initial motivation to exercise. In randomized controlled trials of breast cancer patients that compare supervised exercise to control groups of st andard care and/or se lf-directed exercise, results have been mixed. Segal et al (2001) demonstrated significantly higher improvement on the physical func tion scale of the SF-36 in subjects that practiced selfdirected exercise over those in a supervised exercise program, but no demonstrable effect on quality of life. Alterna tively, Courneya (2003) demons trated significantly higher improvements in both quality of life and car diopulmonary function in a supervised exercise group of post-menopausal breast cancer survivors. Similar results were found in nonrandomized controlled studies that em ployed supervised group exercise therapy (GET) (Kolden et al., 2002). Structured ex ercise programs also have been found to
17 improve exercise tolerance, sleep quality, and quality of life, and help control body weight (Schwartz, 2000b; Winningham et al., 1989; Young-McCaughan et al., 2003). Additional studies of structured exercise programs in cancer survivors have demonstrated decreased levels of depression and anxiet y, less psychological distress, and improved overall mood among those who exercise (Campbell, Mutrie, White, McGuire, & Kearney, 2005; Carter, Drum, Hayward, & Sc hneider, 2003; Pinto, Clark, Maruyama, & Feder, 2003; Schulz et al., 1998). Exercise and Fatigue Research studies have shown that fatigue le vel or intensity of fatigue is related to type of treatment, and in breast cancer patients it is particularly associated with treatment that involves chemotherapy (Donovan et al ., 2004; Woo, Dibble, Piper, Keating, & Weiss, 1998). Fatigue has also been found to be associated with a number of other symptoms, existing as a symptom cluster, and these clusters serve to intensify the effect of the individual symptom (Bender, Er gyn, Rosenzweig, Cohen, & Sereika, 2005; Berger, 2005). Research has also demonstr ated that fatigue lasts well into the posttreatment period and is more intense than normal fatigue and causes more suffering (Holley, 2000a; Sugawara et al., 2005) Only two strategies for fatigue manage ment have had sufficient research to qualify as evidence-based recommendations : management of anemia, and exercise programs (Barsevick, Whitmer, Sweeney, & Nail 2002). A number of studies not only examine the effect of a program of exercise on physical functioning and quality of life, but also test improvement in fatigue level as an endpoint. The use of exercise and sleep have been shown to be the most effective stra tegies used by patients themselves to lessen
18 the effects of fatigue (Graydon, Bubela, Irvine, & Vincent, 1995). Mock et al. (1994) found that an exercise program of walki ng combined with a support group not only improved physical functioning, but lessened th e intensity of 12 symptoms, including fatigue and anxiety. In a la ter study, Mock et al (1997) te sted the effectiveness of a home-based exercise intervention that consis ted of a self-paced walking program that yielded similar results. This was late r supported in a randomized control trial demonstrating that a home based walking progr am is an effective mediator of fatigue (Mock et al., 2005). Additional studies of home-based exercise programs involving walking support this intervention as effec tive in decreasing fatigue, increasing physical functioning and improved quality of life (S chwartz, 1999, 2000a; Schwartz, Mori, Gao, Nail, & King, 2001) Educational instruction has been tested for effectiveness in managing fatigue levels. An eight week program of edu cation and support that included exercise instruction and energy conser vation instruction demonstrat ed significant differences between pre-to post measures for fatigue a nd quality of life in patients with cancer. (Holley & Borger, 2001). These results were supported by a pilot study demonstrating that a large scale fatigue management pr ogram consisting of telephone education for energy conservation and management of activity is useful in reducing fatigue (Barsevick et al., 2002). Conceptual Framework The guiding conceptual framework for this study is based on the Patient Active concept of The Wellness Community. This concep t was developed by The Wellness Community founder, Harold Benjamin, a social psychologist. The Patient Active concept posits that
19 patients who actively participate in their ca ncer treatment and fight for recovery may actually enhance their re covery (Benjamin, 1987). A cancer diagnosis usually imposes a certa in degree of loss of personal control. A patient becomes entrenched in appointments for work-ups such as blood work and multiple imaging studies, treatments such as weekly chemotherapy that are sometimes followed by daily injections to prevent inf ection, and periods of frustration waiting for test results and other information. Physical side effects of treatments can further victimize a patient by limiting their normal activ ities of daily living. The Return to Wellness program provides psychosocial support a nd education from credible authorities, such as physicians, nurses, licensed mental h ealth counselors, psychologists, dieticians, and survivors in order to empower women to wards healthy psychological adjustment and maintaining a sense of personal control. It also teaches physical se lf-help strategies to manage fatigue, loss of strength, and loss of flexibility, thus enabling women to actively facilitate their recovery from breast cancer (Figure 1). Figure 1. Conceptual Model Mediating Factor Return to Wellness Program Physiological & Psychological variables: Breast Cancer patient with 1. Fatigue 2. Decreased physical & social functioning 3. Uncertainty Expected Outcomes: 1. Less distress from Fatigue 2..Less Uncertainty 3. Improved physical & social functioning Factors impacting participation/outcomes: Uncertainty Support Symptoms
20 Summary Chapter two has established that breast cancer survivors experi ence symptoms of psychosocial distress in the form of uncerta inty and that social support and education from credible authorities are effective in f acilitating adjustment. Breast cancer survivors also experience extended levels of fatigue and decreased physic al functioning that continues long into the post-treatment phase of survivorship. Physic al exercise has been shown to improve physical functioning, elevat e mood, and reduce levels of fatigue in breast cancer survivors who par ticipate in structur ed or home-based exercise programs. Programs that combine interventions have also been successful in demonstrating improvement of symptoms. It is important to test the efficacy of a combined program of physical activity, education and social s upport in improving health outcomes.
21 Chapter Three Method Research Design The purpose of this study was to measure the effects of the Return to Wellness program, a 10-week program of supervised phys ical exercise, education, and psychosocial support on physical functioning, uncertaint y and distress from fatigue. This study employed a two-group repeated measures compar ative design. This chapter describes the study design and method. Sample and Setting Subjects for the experimental group we re recruited from those women who registered for the Return to Wellness program. To participate in the Return to Wellness program, a woman must have had a diagnosis of breast cancer and have completed her treatment in the last three weeks to two year s. She must not have had any known active cancer disease. Each Return to Wellness par ticipant signed a consent form to participate prior to beginning the program (Appendix A). The women were told that they must have approval from their physicians, and their phys icians either signed the patient consent form or wrote an approval on a prescription slip or practice letterhead. Prior to the program, medical history, exer cise history and nutritional history forms were completed (Appendix B). The 20 sessions of the Return to Wellne ss program consisted of two sessions per week for 10 weeks. Each session was two hour s long, and all sessions were delivered in
22 a group setting. A sample program schedule is included in Appendix C. Each week, the participant received strength and conditioning in struction from a physical therapist in the form of weight training or re sistance training with TheraBand activity, which are elastic bands in varying degrees of resistance. Th e bands can be used to work many different muscle groups by causing two di fferent types of contraction. Each participant in the Return to We llness program was screened by the physical therapist for the presence of lymphedema in the affected arm(s). The physical training sessions lasted approximately one hour a nd were preceded by a one hour support group. The second session of the same week involve d a one hour educational session that was mainly focused on managing physical or psycho logical symptoms such as fatigue through energy conservation; eating pr operly, managing feelings, a nd dealing with insurance issues. The educational session was follo wed by a one hour yoga session taught by a certified yoga instructor. The yoga was focu sed on breathing exercises and meditation. It was mainly seated yoga and involved minimal mat work. At the end of the 10 week program a graduation was held. Control subjects were recruited from tw o large private oncology clinics and an area hospital clinic. Potential subjects were referred to the investigator by health care providers at these facilities. Subjects contacted the investigator for information about the study. Control subjects had to meet the eligibility criteria for the Return to Wellness program; that is, they must have completed tr eatment in the last three weeks to two years and have had no evidence of cancer disease. Control subjects did not require physician permission as they were not participating in an intervention, and there were no known risks to filling out health surv eys and questionnaires Exclus ion criteria was the same as
23 the Return to Wellness program, that is, ev idence of disease; or pre-existing cardiac disease. All Return to Wellness sessions and interventions took place either in an outpatient satellite campus of a large community hospital, or at The Wellness Community. Instruments Medical Outcomes Study Short Form-36 Improvements in physical and social func tioning and vitality were measured by changes in the preto midpoi nt to postscores of th e physical functioning, social functioning, and vitality scal es of the Medical Outcomes Study Short Form36 (SF-36) (Appendix D). The SF-36 Health Survey is a self-administered 36-item scale with eight scales that purport to measure functional he alth and well-being. The eight scales are physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each item has a five choice, Likert-type response check box. A higher score on the scale indicates a higher degree of f unctioning in the area it purports to measure. The eight scales yiel d two summary measures, four of the scales yield a physical summary measure and the othe r four comprise a mental health summary measure (Ware, Snow, & Kosinski, 2000). Scoring the SF-36. Each scale of the SF-36 yields a separate score. A higher score on the individual s cale indicates a better health stat e. Ten items on the SF-36 require recoding. After recoding, raw scale scores were transformed in new scale scores. Transformation was not required unless making comparison to existing data. Validity and reliability. The SF-36 has been used extensively and evidence for content, criterion, construct and predictive validity have been shown. Content validity was
24 assessed by comparing the SF-36 to ten other survey forms. Factor analysis supported construct validity, and correlational studies support criterion validity. Reliability estimates were made using both internal cons istency and test-retest methods. Reliability estimates for the instrument range from .70 to .93 with the majority of studies above .80 (Ware et al., 2000) (Appendix D). Cancer Related Fatigue Distress Scale Distress related to cancer fatigue was measured by the Cancer Related Fatigue Distress Scale (CRFDS) (Holley, 2000a). The CRFDS is a 20 item ratio-level grading scale. Each item is graded on a zero to ten scale. The CRFDS has 20 items that are scored on a zero to 10 numeric rating s cale. A higher score on the scale indicates a higher degree of distress related to fatigue. No recoding or transformation of scores is required. Total scores for this instrument can range from zero to 200. (Appendix D) Validity and reliability Content validity was assessed by means of a content validity index (CVI) using cancer survivors as expert judges. The reported mean content validity index was .91. Construct validity was supported by factor an alysis with items loading on a single factor soluti on. Reliability estimates for internal consistency from the CRFDS instrument development study demonstrat ed a CronbachÂ’s alpha coeffcient of .97. Mishel Uncertainty in Illness Scale Uncertainty was measured by the Mishel Uncertainty in Illness Scale-Community Form (MUIS-C), a 23-item scale that measures uncertainty that is perceived in illness developed by Dr. Merle Mishel (1981). The scale has four subscales which are ambiguity, unpredictability, complexity, and inconsistency of information. Only the total score for this instrument was used in th is study. Each item is scor ed on a five-point, Likert-type
25 scale. Higher scores on the MUIS-C indicate a higher degree of uncertainty. Total scores can range from 23-115. Validity and reliability. Construct validity for the MUIS-C has been supported through factor analysis. According to Mishel and Braden (1987), reli ability estimates for internal consistency of the MUIS demonstrate alpha coefficients of greater than .92 The MUIS-C has been used extensively in studies of breast cancer survivors (Longman et al., 1997, 1999). Procedures Approvals A letter indicating support for the st udy was obtained from The Wellness Community. Support letters were also secure d from the two local oncology clinics. Approval for this study was received from th e University of Sout h Florida Institutional Review Board for Human Subjects Protection, as well as the Sarasota Memorial Hospital Institutional Review Board. In order not to burden subjects with two consent forms, the Sarasota Memorial Hospital IRB agreed to waiv e their informed consent form in favor of the University of South Florida IRB consent form (Appendix E). Intervention Subjects were contacted and recruited by an Â“invitation to participateÂ” letter handed out at the time of registration for th e Return to Wellness program (Appendix F). Potential subjects for matched controls were in vited to participate by letter to those on the waiting list for the Return to Wellness pr ogram, and by invitational letters or by a personal invitation to pa rticipate to patients identified by clinic physicians and staff as a patient who has completed treatment. For thos e who expressed interest in participating in
26 the study, the investigator explained the st udy and answered any questions. Signatures on the informed consent were obtained by the investigator, and the study participants were given a copy of their consent form to keep. Data Collection For study participants who were enrolled in the Return to Wellness program, data collection with the SF-36, CRFDS and MUIS-C occurred imme diately prior to the first session, again prior to the 5th session, and again immediat ely after the end of the 10week session. For participants who were ma tched controls, data co llection began at the time of informed consent. Surveys were mailed at time of consent, mailed again five weeks later, and again at approximately 10 weeks after the date on the first survey. Participants who did not return their forms we re called to determine whether they wanted to continue in the study. Data Analysis The Statistical Package for the Social Sc iences (SPSS) (version 13.0) was used for all data analysis and data management A two-way repeated measures ANOVA with between-groups design was employed. A priori power analysis had determined that 45 subjects per group were needed for a medium effect at an alpha level of .05 and a correlation of .05 for a design with three m easures. However, the Return to Wellness program was affected by dwindling interest in the program and lack of funding to continue. After three 10-week programs over the period of one year, only 19 subjects had agreed to participate. Two of those s ubjects did not complete the program and their data could not be included as they only t ook the pre-test measures. Similar lack of interest occurred in getting h ealth care providers to recomm end the study to women with
27 breast cancer who finished treatment. After a one year period, only 16 women agreed to participate and three of those women decide d not to complete th e study, citing personal reasons. Data are presented descriptively as per centages for categorical variables and as means and percentages for cont inuous variables. The data an alysis plan is presented below with each hypothesis. The hypothe ses in this study were as follows: Women treated for breast cancer who complete the Return to Wellness program will: 1. report significantly improved physical func tioning, social functioning and vitality compared to a control group as reported on PF, SF and VT scales of the SF-36. After recoding and scoring, these three sc ale variables were analyzed for means and standard deviations by time and by group. Repeated measures ANOVA was employed to analyze the main effects of time, the main effects of group, and the interaction effect of time by group. 2. have significantly lower scor es on the Mishel Uncertainty in Illness Scale (MUIS) compared to a control group. After scori ng, the total instrument scores were analyzed for means and standard deviat ions by time and by group. The subscales of this instrument were not analyzed. Repeated measures ANOVA was used to analyze the main effects of time, the main effects of group, and the interaction effect of time by group. 3. report significantly less distress from fatigue on the Cancer Related Fatigue Distress Scale (CRFDS) compared to a control group. After scoring, the total instrument scores were analyzed for m eans and standard deviations by time and
28 by group. Repeated measures ANOVA was used to analyze the main effects of time, the main effects of group, and th e interaction effect of time by group. In addition, a chi-square test was performe d to look for significant differences in the demographic profiles of the two subject groups and an independent samples t-test was conducted to look for significant difference in mean age between the two groups.
29 Chapter Four Results Chapter four presents the study results. Results are organized as follows: profile of the study groups and an an alysis of each study aim. Profile of Samples Experimental group A convenience sample of 17 breast cancer su rvivors who enrolled in the Return to Wellness program were recruited to participat e in the study. Descript ive statistics were performed on demographic and clinical in formation. One subject did not provide information on lymph node involvement and c onsequently that variable is based on a sample size of 16. The median and mean age of the subjects in this group was approximately 55 and 56 years respectively. There was a wide range in age of subjects within this study sample, with the youngest be ing 38 years of age and the oldest being 75 years of age. The most common age was 51 years (three subjects) followed by 66 years (two subjects). As depicted in Table 1, the sample was primarily Caucasian, and with an average of 14 years of education. One hundred percen t of the sample had surgery, 65% being in the form of lumpectomy and the other 35% ha ving mastectomies. All of the women in
30 this sample reported having participated in a support group and 65% reported currently performing some type of exercise. Table 1 Sample Composition Group ____________________________________ Characteristics Experimental Control ____________________________________ ( f ) % ( f ) % ________________________________________________________________________ Total 17 100 13 100 Ethnicity Caucasian 16 94 13 100 African American 0 0 0 0 Hispanic 1 6 0 0 Type of Surgery Lumpectomy 11 65 5 42 Mastectomy 6 35 7 54 Lymph node involvement None 8 47 9 69 Local 5 29 0 0 Regional 2 12 1 8 DonÂ’t know 1 6 2 15 Treatment Modality Surgery 17 100 13 100 Chemotherapy 14 82 6 46 Radiation Therapy 11 65 6 46 Hormone Therapy 9 53 7 54 Other 1 6 0 0 Experienced Lymphedema 4 24 0 0 Currently Exercise 11 65 8 62 Attended a Support Group 17 100 3 23 Mean SD Mean SD Age 56 10.49 64 9.77 Years of Education 14 1.69 14 1.65
31 Control group A convenience sample of 13 breast cancer survivors who were referred to the investigator by area health care providers agr eed to participate in, and completed this study. Descriptive statistics were also pe rformed on this sample. As with the experimental sample, one subject did not provide information on lymph node involvement, and one additional subject did not provide information on type of surgery. The sample size for these two variables is 12 subjects. The median and mean age of subjects for this sample was 66 and 64 years respectively. The age range for this sample was also broad, with the youngest being 46 year s of age and the oldest being 80 years of age. The mode for this sample was 66 years. The subjects in this sample were a ll Caucasian and, like the experimental group, had an average of 14 years education. Among the 12 subjects who reported their surgical status, 42% had lumpectomy and 54% had mastectomy. Only 23% of this sample reported having participated in a support gr oup, but 62% reported currently engaging in some form of exercise. A chi-square test was performed to te st the null hypothesis that there were no differences between the profiles of the experime ntal and the control subjects in this study. It is interesting that there were similarities between the subject groups w ith the exception of two areas (Table 1). Firs t, there was a difference regard ing the type of treatments. The experimental group subjects had been treat ed with chemotherapy more often than the control group (p=.037). In a ddition, the subjects in the expe rimental group had utilized a support group more than the control group. Both of these differences were statistically
32 significant (p=.000). An independent samples ttest found that the age difference between the two groups was not significant. Comparison of Subjects on Physical and Social Functioning and Vitality The first hypothesis of this study was to examine and compare the scores of the Return to Wellness study participants to a control group on the Physical Functioning (PF), Social Functioning (SF) and Vitality (VT) scales of the Medical Outcomes Study SF-36 Health Survey (Ware et al., 2000). The su bjects were tested at three distinct points in time: prior to beginning the 10-week program, at midpoint, and at completion. The control subjects were tested at the time of in formed consent, and again at five and ten weeks post consent. The means and standard deviations for the two subject groups are depicted in Table 2. The means for the expe rimental group were lower on all three scales at Time 1, indicating an initia lly lower level of functioning than the control subjects. At Time 3, the means of the experimental gr oup were higher than the control group on all three scales, indicating a higher level of functioning. The null hypothesis of no significant differences in physic al functioning, social function ing, and vitality before and after a 10 week period was tested using a repeated measures ANOVA with betweensubjects analysis. The main effects of tim e and the interaction e ffect of group by time were significant on the social functioning and vitality scale, and approaching significance for the physical functioning scale (p=.06). Th e main effect of group was not significant on any of the scales. For all three scales the control group showed slight decline in scores over time, but not at a statistica lly significant level (Tables 3, 4, and 5).
33 Table 2 Descriptive Statistics by Group for PF, SF, and VT Scales of the SF-36 Health Survey Measure Group Mean SD n ________________________________________________________________________ PF Time 1 Control 24.23 3.67 13 Experimental 22.41 3.62 17 PF Time 2 Control 23.69 3.63 13 Experimental 23.41 2.95 17 PF Time 3 Control 23.69 3.96 13 Experimental 25.29 2.71 17 SF Time 1 Control 8.69 1.97 13 Experimental 7.17 2.21 17 SF Time 2 Control 8.23 2.35 13 Experimental 8.29 1.40 17 SF Time 3 Control 8.46 2.06 13 Experimental 9.23 1.48 17 VT Time 1 Control 14.30 5.40 13 Experimental 11.58 3.24 17 VT Time 2 Control 13.69 4.95 13 Experimental 12.82 3.87 17 VT Time 3 Control 14.07 3.96 13 Experimental 15.23 3.64 17 Table 3 Physical Functioning: Main Ef fects and Interaction Effect Source SS df MS F p ________________________________________________________________________ Time 22.71 2 11.35 2.91 .062 Group .608 1 .608 .022 .882 Time* Group 43.24 2 21.62 5.55 .006 ________________________________________________________________________
34 Table 4 Social Functioning: Main Effect s and Interaction Effect Source SS df MS F p ________________________________________________________________________ Time 12.63 2 6.31 3.99 .024 Group 1.13 1 1.13 .143 .708 Time*Group 20.23 2 10.11 6.40 .003 ________________________________________________________________________ Table 5 Vitality: Main Effects and Interaction Effect Source SS df MS F p ________________________________________________________________________ Time 48.80 2 24.40 3.65 .032 Group 14.49 1 14.49 .375 .545 Time*Group 55.42 2 27.71 4.15 .021 ________________________________________________________________________ The within-subjects main effects of im provement over time were statistically significant for the experimental group on all three scales, but not significant for the control group on any of the th ree scales. The results by subject group are depicted in Tables 6, 7, and 8.
35 Table 6 Physical Functioning: Main Effect of Time by Subject Groups Source SS df MS F p ________________________________________________________________________ Time Â–Control 2.51 2 1.25 .578 .569 TimeExperimental 72.82 2 36.41 7.02 .003 Table 7 Social Functioning: Main Effect of Time by Subject Groups Source SS df MS F p ________________________________________________________________________ Time Â–Control 1.38 2 .692 .543 .588 TimeExperimental 36.11 2 18.05 9.98 <.001 Table 8 Vitality: Main Effect of Time by Subject Groups Source SS df MS F p ________________________________________________________________________ Time Â–Control 2.51 2 1.25 .284 .755 TimeExperimental 116.98 2 58.49 6.99 .003 Comparison of Subjects on the Mishel Uncertainty in Illness Scale The second hypothesis of this study was to determine if there are differences over time in the level of uncertainty experienced by the subjects in the experimental group versus the control group subjects. The means and standard deviations for the two groups for this variable are depicted in Table 9. Scor es on this instrument can range from 23 to
36 115 with higher scores indicating a greater le vel of uncertainty. The control group had a non-significant slight increase in scores over time. The repeated measures analysis of variance for the main effects of time, group, and the interaction e ffect of time by group appear in Table 10. The repeated meas ures ANOVA also demonstrated that the experimental group had a statis tically significant decline in uncertainty scores over time, indicating that they we re experiencing a lesser degree of uncertainty compared to Time 1. The results appear in Table 11. Table 9 Descriptive Statistics by Gr oup for the Mishel Uncertainty in Illness Scale (MUIS-C) Measure Group Mean SD n ________________________________________________________________________ MUIS Time 1 Control 45.00 20.51 13 Experimental 53.41 10.91 17 MUIS Time 2 Control 47.69 20.25 13 Experimental 50.52 12.13 17 MUIS Time 3 Control 46.76 18.82 13 Experimental 43.64 14.19 17 Table 10 Uncertainty: Main Effects and Interaction Effect Source SS df MS F p ________________________________________________________________________ Time 306.67 2 153.33 4.10 .022 Group 162.17 1 162.17 .231 .634 Time* Group 490.18 2 245.09 6.55 .003
37 Table 11 Uncertainty: Main Effect of Time by Subject Groups Source SS df MS F p ________________________________________________________________________ Time Â–Control 48.66 2 24.33 .590 .562 TimeExperimental 855.80 2 427.90 12.40 <.001 Comparison of Subjects of the Cancer Related Fatigue Distress Scale (CRFDS) The final hypothesis of this study was to ascertain if there are significant differences in the amount of cancer related fatig ue distress experienced by subjects in the Return to Wellness program versus a group of control subjects on the Cancer Related Fatigue Distress Scale. The means and sta ndard deviations for the two groups on this measure are reported in Table 12. Scores on this instrument can range from 0-200, with higher scores indicating a greater level of distress from cancer related fatigue. At Time 1, the experimental subjects ha d higher mean scores than the control group. Repeated measures analysis of variance for the main effects of time and gr oup and the interaction effect of time by group results appear in Table 13. The within-subjects effects demonstrated a statistically significant decline in scores for the experimental subjects indicating that they we re experiencing less distress from cancer related fatigue over time. The analysis of within-subject s effects for the control group yielded no significant change in scores. These results appear in Table 14.
38 Table 12 Descriptive Statistics by Group for the Cancer Related Fatigue Distress Scale Measure Group Mean SD n ________________________________________________________________________ CRFDS Time 1 Control 67.76 59.37 13 Experimental 89.11 46.13 17 CRFDS Time 2 Control 67.15 61.30 13 Experimental 73.05 43.84 17 CRFDS Time 3 Control 66.38 60.78 13 Experimental 67.47 52.47 17 Table 13 Cancer Related Fatigue Distress: Main Effects and Interaction Effect Source SS df MS F p ________________________________________________________________________ Time 2928.97 2 1464.48 3.82 .028 Group 1337.60 1 1337.60 .171 .682 Time* Group 2389.51 2 1194.75 3.12 .052 Table 14 Cancer Related Fatigue Distress: Main Effect of Time by Subject Groups Source SS df MS F p ________________________________________________________________________ Time Â–Control 12.51 2 6.25 .035 .966 TimeExperimental 6120.35 2 3060.17 5.70 .008
39 Chapter Five Discussion The focus of this study was to determin e the effects of a structured 10-week combined recovery program for breast cance r survivors called Return to Wellness. Chapter five discusses findings, conclusions, study limitations, and discusses implications for nursing practice and education. It al so discusses recommendations for future research. The hypotheses for this study were as follows: Women with breast cancer who complete the Return to Wellness program will: 1. report significantly improved physical func tioning, social functioning and vitality compared to a control group as reported on PF, SF and VT scales of the SF-36. 2. have significantly lower scor es on the Mishel Uncertainty in Illness Scale (MUIS) compared to a control group. 3. report significantly less distre ss from fatigue on the Cancer Related Fatigue Distress Scale (CRFDS) compared to a control group. Physical and Social Functioning and Vitality The mean pre-test (Time 1) scores of th e experimental subjects were lower than those of the control group on all three of these scales of the SF-36, indicating a lower level of functioning. At completion of the Re turn to Wellness program, the scores of the subjects had improved significantly over time, whereas there were no significant differences in the control group on any of the three measures. Both groups of subjects
40 reported participating in exercise prior to beginning the study (65% of the experimental group and 62% of the control group). This was not a statistically significant difference. Although there was improvement in the scores of the experimental subjects, it is not known if they, or the control group, were exercising according to the CDC recommendations of 30 minutes of moderate activity five times per week or 20 minutes or more of vigorous activity three times per week (Depar tment of Health and Human Services Centers for Disease Control and Prevention/American College of Sports Medicine, 2005). The Return to Wellness program does not have written goals and objectives. In developing and articulating goa ls and objectives for the program, it may be beneficial to use the CDC guidelines or to write objectives to a target metabolic equivalent task (MET) for each session. One MET is equivalent to sitting quietly, while average-paced walking equals 3 MET (Hol mes, 2005). It may also be helpful to introduce various types of exercise other than yoga, free weights, or resistance bands, as the literature demonstrates that patients are more likely to exercise when the exercise is matched to their preference (Courneya, 2003). Uncertainty in Illness The mean scores of the experimental s ubjects on the first two measures of the Mishel Uncertainty in Illness Scale were higher than those of the control group, indicating that the experiment al group was experiencing a high er level of uncertainty. Anecdotally, one subject in the experimental group commented to the researcher just before the midpoint assessment that she t hought the midpoint survey values might be worse because she felt that as a group, they were just delving into psychological issues that could not be previously addressed due to the more pressing needs of physical
41 treatment. However, the mean scores of the midpoint assessment were slightly lower, and the level of uncertainty across all three measurement points continued to decline. This finding was statistica lly significant. Meanwhile, there were no statistically significant changes across time in the scores of the contro l group. The changes in the scores of the experimental group support Mish elÂ’s Uncertainty in Illness Theory that purports that, according to Mishel, (1990) educat ion, credible authority and social support are effective mediators of uncertainty. The Return to Wellness program provided support and/or education at every session, but what is not known is how much social support or education was received outsi de the program. The demogr aphic form completed by the Return to Wellness participants, as well as the information sheet completed by the control group did not inquire about marital or significan t other status. Prior to beginning the Return to Wellness program, 100% of the e xperimental group reported having attended a support group, whereas only 23% of the c ontrol subjects report ed visiting a support group, which was a statistic ally significant finding. Cancer Related Fatigue Distress The experimental group had higher mean scores on the Cancer Fatigue Related Distress Scale than the control subjects at all three time points, indicating a greater amount of distress and suffering associated with fatigue (Holley, 2000b) This could possibly be attributed to th e fact that the experimental group had significantly more chemotherapy than the control group, and this treatment is associated with a higher incidence and degree of fati gue (Donovan et al., 2004; Woo et al., 1998). Even so, the experimental group of Return to Wellness pa rticipants had a stat istically significant decrease over time in their scores on the CRFDS. The control group did not have a
42 statistically significant change in scores ove r time on this instrument. The Return to Wellness program includes a lecture on fati gue management and energy conservation. The program also includes twice-weekly exerci se sessions. Exercise is known to be a mediator of fatigue (Barsevick et al., 2002). Limitations of the study Sample In order for this study to have power to detect a medium effect size, the intended sample for each group in this study was 45 subjects. However, lack of participants in the Return to Wellness program and lack of re ferrals of post-treatment survivors by area health care providers contribu ted to low enrollment in the study. In the end, funding was cut for the Return to Wellness program so that the program was not able to continue as often or with the same curriculum. Another sample limitation of this study is that these two convenience samples consisted primarily of Caucasian women. Th e experimental group was 94% Causcasian and 6% Hispanic. The control group wa s 100% Caucasian. There were no African American women recruited into the study. The group demographics do not adequately represent the community in which the Return to Wellness program is held, nor do they represent the ethnic distributi on of women with breast cancer (American Cancer Society, 2004). Despite efforts on the part of Th e Wellness Community to reach out to the African American and Hispanic communities, and in particular to attempt to recruit African American and Hispanic breast cance r survivors into the Return to Wellness program, these minority groups of survivors are not being reached, nor studied for the effects of a recovery program. There are two possible explanations. The first is location.
43 The Wellness Community and the satellite cent er of the partner hospital are located a fairly good distance from the African Amer ican and Hispanic communities, and not easily accessible via public transportation. Th e second possible reason is that statistics bear out the fact that minority women are ofte n diagnosed with breast cancer at a later stage than Caucasian women (American Cancer Society, 2004). Women who are diagnosed at a later stage may have poorer pe rformance status and therefore may not be able to travel to or particip ate in a recovery program. Method Because this was not a randomized control tr ial, there is a degree of bias in that the subjects self-sel ected to participate in the study. It is not k nown if subjects responded in a socially desirable way on the surveys. Several subjects in the control group seemed determined to reveal their identity by sending signed notes and cards with their surveys, adding their return address to the pre-addressed return addres s, and putting return address stickers on every page of every survey. All identifying data was removed by the investigator, but even with such maneuvers, it is impossible to know that the surveys were actually completed by the subject to w hom they were addressed. Another limitation in method is that the Return to Wellness program is a multifacted intervention, and it is difficult to attribute cause and effect to one si ngle intervention in order to determine what had the greatest effect. Generalizability Although it is tempting to generalize the findi ngs of this study in order to move toward evidence-based recommendations for car e, these findings are what they are: a representation of the small numbe r of specific survivors who agr eed to participate in this
44 study. It would be inappropriate to generalize these finding to other recovery or exercise programs, or to groups of cancer patients or post-treatment survivors. These results definitely cannot be applied to populations that were not represented in the subject groups. It is possible that women who chose not to part icipate in the study were systematically different from those who did par ticipate. This also limits generalizability. Further studies are recommended across vari ous geographic areas and ethnic populations to test for social and cultural sensitiv ity and preference in addition to effect. Recommendations for Future Research Nurses should continue to investigate the effects of posttreatment recovery programs for breast cancer survi vors. They should be invol ved in the design of these programs and see that goals and objectives are outcome and evidence-based. Future research studies should examine barriers to pa rticipation in post-recovery programs, and test interventions that motivat e and sustain survivors to participate. Nursing should also investigate whether the ideal locale for a recovery program is home-based or in a structured group, and how long programs should be and what they need to include in order to be effective. Nursing should conduc t long term longitudina l studies of survivors who sustain the CDC recommendations for physical activity to examine effect on recurrence and survival. We should also investigate culturally sensitive issues surrounding participation in recovery programs in order to bring the same standard of care to minority and under served populations.
45 Conclusion All three of the hypotheses in this study are confirmed. Based on the findings of this study, a formal recovery program should be considered for breast cancer survivors who have completed treatment. The Return to Wellness program was an effective mediator of uncertainty and cancer related fatigue distress for the group of subjects who completed the program. The subjects also realized improved physical and social functioning, and an increased level of vitality versus a similar group of control subjects. Future research is recommended to test for effects in more divers e populations, and in a randomized control trial setti ng in order to support formalized recovery programs as evidence-based practice recommendations.
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53 Appendix A: Consent to Participat e in the Return to Wellness Program
54 RETURN TO WELLNESS Waiver and Physician Release Agreement I, the UNDERSIGNED, fully understand and agree to the following: 1. The Wellness CommunitySouthwest Florida, through its Return to Wellness Program, will provide a ten-week program for women who have recently completed treatment for breast cancer. This program will meet for two hours, twice each week. Of the four hours per week, there will be one hour of yoga one hour of strength training (using resistance bands), one hour of support group, and one hour of educational programming on nut rition and other breast cancerrelated topics. The purpose of this program is to encourage breast cancer survivors to optimize thei r recovery by improving their physical health, knowledge of healthy living practices, and social/emotional health. 2. Participation in any exercise program, such as the yoga and strength training programs offered in Return to Wellness, may result in foreseeable or unforeseeab le injury or illness, including, but not limited to, bodily injury, de ath, disease, strains, fractures, herniations, ruptures, tears, partial or total paralysis, heart attacks, stroke, infection, allergic reacti on, and other ailments that could cause serious disability. 3. Prior to your participation in Return to Wellness, The Wellness Community-Southwest Florida, requir es you to consult with your physician regarding your participat ion in the exercise programs, as consistent with your health care regimen and appropriate to your medical condition. Your doctor also hereby acknowledges that
55 your active cancer treatment was completed at least three weeks, but no more than two years, ago. 4. By affixing your signature to this document in the space provided below, you, and all your personal representatives, assigns, heirs, spouse and next-of-kin, agree to release, waive, discharge and hold harmless The Wellness Community-Southwest Florida and Sarasota Memorial Health Care System and its respective employees, shareholders, o fficers, agents, independent contractors, volunteers and dono rs from any and all claims, actions, demands, liabilities, expens es (including attorneysÂ’ fee) and losses arising from bodily injury or illness as described above, including, but not limited to, wrongf ul death, loss of services, loss of consortium, and all other da mages that may arise our of participation in the Return to Wellness program as described above. THE UNDERSIGNED HAS READ AND UNDERS TOOD THE WAIVER AND RELEASE AGREEMENT. Signature:______________________ ______________________ _________ Return to Wellness Participant Print Name Date (the UNDERSIGNED) ___________________________ __________________________ ___________ Physician Signature Print Name Date
56 Appendix B: Participant Personal History Form
57 Measuring the Effects of Rehabilitati on Program for Breast Cancer Survivors Principal Investigator: Keri Hockett ARNP MSN AOCN Participant Information Name________________________________________Date of Birth______________ Highest grade completed________________________Ethnicity__________________ Type of cancer__________________________________________________________ Lymph node involvement _____local _____reg ional _____metastati c _____not sure Number of lymph nodes involved__________________________ ______not sure Type of surgery performed and date _________________________________________ When did you complete your treatment? (do not consider hormone therapy such a s tamoxifen or Arimidex, Femara, etc) __________________________________________ Therapies used to treat y our breast cancer ____surgery ____chemotherapy ____radiation ____hormone therap y ____biotherapy __other___________________ Have you experienced lymphedema si nce your surgery? ___yes ___no Do you currently participate in any form of exercise? ___yes ___no If yes, what type of exer cise do you participate in?_______________________________ How often do you participate in the above exercises? _____________________________ Have you ever attended a cancer support gr oup? ___yes ___no
58 Appendix C: Sample Return to Wellness Schedule
59Return To Wellness Â– Southwest Florida Winter Course Schedule Blake Medical Center Week 1 Â– January 12th & 15th Monday 9:30 Â– 11:45 Thur sday 9:30 Â– 11:45 Orientation/Introductions Assessments Conditioning & Range of Motion Week 2 Â– January 19th & 22nd Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Education 10: 45 Â– 11:45 Conditioning & Range of Motion Week 3 Â– January 26th & January 29th Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Â“Understanding Our Feelings: How To Manage Emotional Dis-easeÂ” M.R. Lembright, LMHC 10:45 Â– 11:45 Conditioning & Range of Motion Week 4 Â– February 2nd & February 5th Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Education 10: 45 Â– 11:45 Conditioning & Range of Motion
60 Week 5 Â– February 9th & February 12th Monday Thursday 9:30 Â– 10:30 Yoga 9:30 Â– 10:30 Support Group 10:45Â– 11:45 Education 10:45 Â– 11:45 Conditioning & Range of Motion Return To Wellness Â– Southwest Florida Week 6 Â– February 16th & February 19th Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Education 10: 45 Â– 11:45 Conditioning & Range of Motion Week 7 Â– February 23rd & February 26th Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Education 10: 45 Â– 11:45 Conditioning & Range of Motion Week 8 Â– March 1st & March 4th Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Education 10: 45 Â– 11:45 Conditioning & Range of
61 Motion Week 9 Â– March 8th Â– March 11th Monday Thursday 9:30 Â– 10:30 Yoga 9: 30 Â– 10:30 Support Group 10:45 Â– 11:45 Education 10: 45 Â– 11:45 Conditioning & Range of Motion Week 10 Â– March 15th Â– March 18th Monday Thursday 9:30 Â– 10:30 Yoga 9:30 Â– 11:45 Physical Assessment & Home Exercise Program 10:45 Â– 11:45 Support Group Program Completion & Graduation
62 Appendix D: Instruments
63 CANCER RELATED FATIGUE DISTRESS SCALE (CRFDS) Sandra Holley, PhD, ARNP, AOCN INSTRUCTIONS: Below and on the next 3 pages are a list of problems people sometimes have because of their cancer related fatigue. Pl ease read each one carefully. Pl ease circle the number that best describes HOW MUCH THAT PR OBLEM 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 begi nning, and if you have any questions please ask then now. Please Complete All 20 Items and the 4 additional items on the last page The fatigue or tiredness I am havi ng 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 mu st 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 wh en I canÂ’t 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 distress
64 The fatigue or tiredness I am havi ng causes me distress because it: 5. makes my body feel as though it doesnÂ’t 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 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 physical 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 canÂ’t 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
65 The fatigue or tiredness I am havi ng causes me distress because it: 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 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
66 The fatigue or tiredness I am havi ng causes me distress because it: 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 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 Since having cancer 0 1 2 3 4 5 6 7 8 9 10 Usual fatigue level Since having cancer 0 1 2 3 4 5 6 7 8 9 10 Please circle the one number below that best describes you situation now KARNOFSKY PERFORMANCE SCAL E (Wingard et al., 1991) 100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity; minor signs or 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
67 MISHEL UNCERTAINTY IN ILLNES S SCALECOMMUNITY FORM INSTRUCTIONS: Please read each statement. Take your time and think about what each statement says. Then place an Â“X Â” under the column that most closely measures how you are feeling TODAY. If you agree with a statement, then you would mark under either Â“Strongly AgreeÂ” or Â“AgreeÂ”. If you disagree with a statement, then mark under eith er Â“Strongly DisagreeÂ” or Â“DisagreeÂ”. If you are undecided about how you feel, then mark under Â“UndecidedÂ” for that statement. Please respond to every statement. 1. I donÂ’t know what is wrong with me. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 2. I have a lot of questions without answers. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 3. I am unsure if my illness is getting better or worse Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 4. It is unclear how bad my pain will be. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ Merle Mishel, Revised 1990
68 5. The explanations they give about my condition seem hazy to me Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 6. The purpose of each treatment is clear to me. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 7. My symptoms continue to change unpredictably. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 8. I understand everything explained to me. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 9. The doctors say things to me that could have many meanings. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 10. My treatment is too complex to figure out. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______
69 11. It is difficult to know if the trea tments or medications I am getting are helping Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 12. Because of the unpredictability of my illness, I cannot plan for the future. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 13. The course of my illness keeps changing. I have good and bad days. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 14. I have been given many differing opini ons about what is wrong with me. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 15. It is not clear what is going to happen to me. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 16. The results of my tests are inconsistent. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______
70 17. The effectiveness of the treatment is undetermined. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 18. Because of the treatment, wh at I can do and cannot do keeps changing. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 19. IÂ’m certain they will not find anything else wrong with me. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 20. The treatment I am receivi ng has a known probability of success. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 21. They have not given me a specific diagnosis. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______ 22. The seriousness of my illness has been determined. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______
71 23. The doctors and nurses use everyday langua ge so I can understand what they are saying. Strongly Agree Agree Undecide d Disagree Strongly Disagree (5) (4) (3) (2) (1) _______ ______ ______ ______ ______
72 Your Health and Well-Being This survey asks for your views ab out your health. This information will help keep track of how you feel and how well you are able to do your usual activities. Thank you for completing this survey! For each of the following questions, please mark an in the one box that best describes your answer. 1. In general, would you say your health is: Excellent Very good Good Fair Poor 1 2 3 4 5 2. Compared to one year ago how would you rate your health in general now ? Much better now than one year ago Somewhat better now than one year ago About the same as one year ago Somewhat worse now than one year ago Much worse now than one year ago 1 2 3 4 5
733. The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Yes, limited a lot Yes, limited a little No, not limited at all a Vigorous activities such as running, lifting heavy objects, participating in strenuous sports......................................................................... 1................. 2................. 3 b Moderate activities such as moving a table, pushing a vacuum cleaner, bowling, or playing golf........................................... 1................. 2................. 3 c Lifting or carrying groceries..................................... 1................. 2................. 3 d Climbing several flights of stairs.............................. 1................. 2................. 3 e Climbing one flight of stairs..................................... 1................. 2................. 3 f Bending, kneeling, or stooping................................. 1................. 2................. 3 g Walking more than a mile ......................................... 1................. 2................. 3 h Walking several blocks ............................................. 1................. 2................. 3 i Walking one block ..................................................... 1................. 2................. 3 j Bathing or dressing yourself...................................... 1................. 2................. 3
74 4. During the past 4 weeks have you had any of the following problems with your work or other regular daily activities as a result of your physical health ? Yes No a Cut down on the amount of time you spent on work or other activities....................................................... 1................... 2 b Accomplished less than you would like.................................. 1................... 2 c Were limited in the kind of work or other activities.................................................................................. 1................... 2 d Had difficulty performing the work or other activities (for example, it took extra effort) ............................ 1................... 2 5. During the past 4 weeks have you had any of the following problems with your work or other re gular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Yes No a Cut down on the amount of time you spent on work or other activities..................................................... 1..................... 2. b Accomplished less than you would like................................ 1..................... 2 c Did work or other activities less carefully than usual .............................................................................. 1..................... 2
756. During the past 4 weeks to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups? Not at all Slightly Moderately Quite a bit Extremely 1 2 3 4 5 7. How much bodily pain have you had during the past 4 weeks ? None Very mild Mild Moderate Severe Very Severe 1 2 3 4 5 6 8. During the past 4 weeks how much did pain interfere with your normal work (including both work outside the home and housework)? Not at all A little bit Moderately Quite a bit Extremely 1 2 3 4 5
76 9. These questions are about how you feel and how thi ngs have been with you during the past 4 weeks For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4 weeks ... All of the time Most of the time A good bit of the time Some of the time A little of the time None of the time a Did you feel full of pep?........................... 1....... 2....... 3........ 4........ 5........ 6 b Have you been a very nervous person?....................................................... 1....... 2....... 3........ 4........ 5........ 6 c Have you felt so down in the dumps that nothing could cheer you up?...................................................... 1....... 2....... 3........ 4........ 5........ 6 d Have you felt calm and peaceful?............. 1....... 2....... 3........ 4........ 5........ 6 e Did you have a lot of energy?.................... 1....... 2....... 3........ 4........ 5........ 6 f Have you felt downhearted and blue?.................................................... 1....... 2....... 3........ 4........ 5........ 6 g Did you feel worn out?.............................. 1....... 2....... 3........ 4........ 5........ 6 h Have you been a happy person?................ 1....... 2....... 3........ 4........ 5........ 6 i Did you feel tired?..................................... 1....... 2....... 3........ 4........ 5........ 6
7710. During the past 4 weeks how much of the time has your physical health or emotional problems interfered with your social activities (like visiting friends, relatives, etc.)? All of the time Most of the time Some of the time A little of the time None of the time 1 2 3 4 5 11. How TRUE or FALSE is each of the following statements for you? Definitely true Mostly true Don't know Mostly false Definitely false a I seem to get sick a little easier than other people................................... 1........... 2........... 3........... 4........... 5 b I am as healthy as anybody I know....................................................... 1........... 2........... 3........... 4........... 5 c I expect my health to get worse...................................................... 1........... 2........... 3........... 4........... 5 d My health is excellent............................ 1........... 2........... 3........... 4........... 5 Thank you for completing these questions!
78 Appendix E: Institutiona l Review Board Approval
80 Appendix F: Informed Consent
84 Appendix G: Invitation to Participate
85 Dear Patient: My name is Keri Hockett ARNP, MSN, AOCN and I am a doctoral candidate at the University of South Florida College of Nursing. I am conducting a research study on the effects of a rehabilita tion program on breast cancer su rvivors who have completed treatment. I am looking for the effects of a specific program called Return to Wellness on patient self-report surveys of physical f unctioning, social role functioning, distress from fatigue, and uncertainty. I am asking for volunteers to take a se ries of health rela ted surveys over the course of a 10 week period. I will be seek ing volunteers from the actual Return to Wellness program as well as breast cancer su rvivors who are not pa rticipating in the Return to Wellness program. People who are eligible to participate in this study are women who have had a breast cancer diagnosis and have completed treatment in the last three weeks to two years, and are over age 18, not pregnant, and who currently have no active cancer. The information gained from this st udy may help us unde rstand the role of rehabilitation programs for cancer survivors. If you ar e interested in participating in this research study, an informed consent process explaining the risks and benefits of the study will occur. This will allow you opportunity to ask questions and to decide if you would like participate in the study. To learn more about this study, or to inquire about particip ation, please contact Keri Hockett, ARNP, MSN, AOCN at 941-917-7425 Thank you, Sincerely Keri Hockett Doctoral Candidate University of South Florida College of Nursing
About the Author Keri Ann Cassidy Hockett received a Bach elor of Science in Nursing Degree from Villanova University, Villanova, PA in 1980 and a Master of Science in Nursing Degree from the University of South Florida in Tampa, FL. in 1993. She has worked for the past 25 years at Sarasota Memorial Health Care System in the positions of staff nurse, clinical nurse specialis t, and nurse practitioner in adu lt medical oncology. She has most recently been in the position of clinical nurse researcher, while working towards her Ph.D. degree in nursing at the Un iversity of South Florida. Ms. Hockett was appointed by Florida Gover nor Jeb Bush to a four year term on the Florida Board of Nursing, completing he r term in March 2005. Throughout her term, she served as chair of the ARNP committee, working on key legislative matters that affect advanced nursing practice. She is an active member of the Oncology Nursing Society (ONS) and has presented from the podium several times at the ONS National Congress. She has authored publications in the Clinical Journal of Oncology Nursing and the American Cancer Society textbook A Cancer Resource Book for Nurses 8th Edition.