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BACKGROUND: Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). METHODS: CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. RESULTS: Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations. CONCLUSION: Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.
BACKGROUND: Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). METHODS: CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. RESULTS: Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations. CONCLUSION: Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.
PURPOSE: To review the available literature on the use of complementary and alternative medicine (CAM) treatments for cancer-related fatigue with an aim to develop directions for future research. METHODS: PubMed, EMBASE, CINAHL, PsycINFO, and SPORTDiscus were searched for relevant studies. Original clinical trials reporting on the use of CAM treatments for cancer-related fatigue were abstracted and critically reviewed. RESULTS: CAM interventions tested for cancer-related fatigue include acupuncture, aromatherapy, adenosine triphosphate infusions, energy conservation and activity management, healing touch, hypnosis, lectin-standardized mistletoe extract, levocarnitine, massage, mindfulness-based stress reduction, polarity therapy, relaxation, sleep promotion, support group, and Tibetan yoga. Several of these interventions seem promising in initial studies. CONCLUSION: Currently, insufficient data exist to recommend any specific CAM modality for cancer-related fatigue. Therefore, potentially effective CAM interventions ready for further study in large, randomized clinical trials (eg, acupuncture, massage, levocarnitine, and the use of mistletoe) should be pursued. Other interventions should be tested in well-designed feasibility and phase II trials.
PURPOSE: To review the available literature on the use of complementary and alternative medicine (CAM) treatments for cancer-related fatigue with an aim to develop directions for future research. METHODS: PubMed, EMBASE, CINAHL, PsycINFO, and SPORTDiscus were searched for relevant studies. Original clinical trials reporting on the use of CAM treatments for cancer-related fatigue were abstracted and critically reviewed. RESULTS: CAM interventions tested for cancer-related fatigue include acupuncture, aromatherapy, adenosine triphosphate infusions, energy conservation and activity management, healing touch, hypnosis, lectin-standardized mistletoe extract, levocarnitine, massage, mindfulness-based stress reduction, polarity therapy, relaxation, sleep promotion, support group, and Tibetan yoga. Several of these interventions seem promising in initial studies. CONCLUSION: Currently, insufficient data exist to recommend any specific CAM modality for cancer-related fatigue. Therefore, potentially effective CAM interventions ready for further study in large, randomized clinical trials (eg, acupuncture, massage, levocarnitine, and the use of mistletoe) should be pursued. Other interventions should be tested in well-designed feasibility and phase II trials.
Being diagnosed with a life-threatening disease such as cancer and undergoing treatment can cause unwanted distress and interferes with quality of life. Uncontrolled stress can have a negative effect on a number of biological systems and processes leading to negative health outcomes. While some distress is normal, it is not benign and must be addressed, as failure to do so may compromise health and QOL outcomes. We present the evidence for the role of stress in cancer biology and mechanisms demonstrating how distress is associated with worse clinical outcomes. The National Comprehensive Cancer Network states that all patients be screened with the single-item distress thermometer and to also indicate the source of distress and to get appropriate referral. In addition to the many conventional approaches for managing distress from the fields of psychology and psychiatry, many patients are seeking strategies to manage their distress that are outside conventional medicine such as mind-body techniques. Mind-body techniques such as meditation, yoga, tai chi, and qigong have been found to lower distress and lead to improvements in different aspects of quality of life. It is essential that the standard of care in oncology include distress screening and the delivery of different techniques to help patients manage the psychosocial challenges of diagnosis and treatment of cancer.
Solid organ and stem cell transplant patients and their caregivers report a substantial level of distress. Mindfulness-based stress reduction has been shown to alleviate distress associated with transplant, but there is limited experience in this population with other mindfulness-based interventions, or with combined transplant patient and caregiver interventions. We evaluated a novel, 6-week mindfulness-based resilience training (MBRT) class for transplant patients and their caregivers that incorporates mindfulness practice, yoga, and neuroscience of stress and resilience. Thirty-one heart, liver, kidney/pancreas, and stem cell transplant patients and 18 caregivers at Mayo Clinic in Arizona participated. Measures of stress, resilience, depression, anxiety, health-related quality of life, positive and negative affect, and sleep were completed at baseline, 6 weeks, and 3 months postintervention. At 6 weeks and 3 months, patients demonstrated significant (P<.005) improvements from baseline in measures of perceived stress, depression, anxiety, and negative affect. Quality-of-life mental component (P=.006) and positive affect (P=.02) also improved at follow-up. Most participants adhered to the program, were satisfied with class length and frequency, and reported improved well-being as a result of the class. MBRT holds promise as an intervention to enhance resilience and manage stress for transplant patients and their caregivers.
Solid organ and stem cell transplant patients and their caregivers report a substantial level of distress. Mindfulness-based stress reduction has been shown to alleviate distress associated with transplant, but there is limited experience in this population with other mindfulness-based interventions, or with combined transplant patient and caregiver interventions. We evaluated a novel, 6-week mindfulness-based resilience training (MBRT) class for transplant patients and their caregivers that incorporates mindfulness practice, yoga, and neuroscience of stress and resilience. Thirty-one heart, liver, kidney/pancreas, and stem cell transplant patients and 18 caregivers at Mayo Clinic in Arizona participated. Measures of stress, resilience, depression, anxiety, health-related quality of life, positive and negative affect, and sleep were completed at baseline, 6 weeks, and 3 months postintervention. At 6 weeks and 3 months, patients demonstrated significant (P<.005) improvements from baseline in measures of perceived stress, depression, anxiety, and negative affect. Quality-of-life mental component (P=.006) and positive affect (P=.02) also improved at follow-up. Most participants adhered to the program, were satisfied with class length and frequency, and reported improved well-being as a result of the class. MBRT holds promise as an intervention to enhance resilience and manage stress for transplant patients and their caregivers.
Solid organ and stem cell transplant patients and their caregivers report a substantial level of distress. Mindfulness-based stress reduction has been shown to alleviate distress associated with transplant, but there is limited experience in this population with other mindfulness-based interventions, or with combined transplant patient and caregiver interventions. We evaluated a novel, 6-week mindfulness-based resilience training (MBRT) class for transplant patients and their caregivers that incorporates mindfulness practice, yoga, and neuroscience of stress and resilience. Thirty-one heart, liver, kidney/pancreas, and stem cell transplant patients and 18 caregivers at Mayo Clinic in Arizona participated. Measures of stress, resilience, depression, anxiety, health-related quality of life, positive and negative affect, and sleep were completed at baseline, 6 weeks, and 3 months postintervention. At 6 weeks and 3 months, patients demonstrated significant (P<.005) improvements from baseline in measures of perceived stress, depression, anxiety, and negative affect. Quality-of-life mental component (P=.006) and positive affect (P=.02) also improved at follow-up. Most participants adhered to the program, were satisfied with class length and frequency, and reported improved well-being as a result of the class. MBRT holds promise as an intervention to enhance resilience and manage stress for transplant patients and their caregivers.