Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study.

PURPOSE: Weight gain is common among breast cancer patients and may contribute to poorer treatment outcomes. Most programs target breast cancer survivors after the completion of therapy and focus on weight reduction. This study examined the feasibility and preliminary efficacy of an intervention designed to prevent primary weight gain among women receiving neoadjuvant chemotherapy for breast cancer. METHODS: Thirty-eight newly diagnosed stage II or III breast cancer patients were randomized to the BALANCE intervention or usual care within 3 weeks of starting neoadjuvant chemotherapy. The intervention used a size acceptance-based approach and encouraged home-based resistance and moderate-intensity aerobic exercise as well as a low energy-dense diet to prevent weight gain. Assessments were conducted at baseline, mid-chemotherapy (3 months), and post-chemotherapy (6 months). Intervention feasibility, acceptability, and preliminary effects on anthropometric, quality of life, and circulating biomarker measures were evaluated. RESULTS: Intervention participant retention (100%) and in-person session attendance (80%) were high during the intervention period, although attendance dropped to 43% for telephone-delivered sessions. The majority of participants reported being satisfied with the intervention during chemotherapy (88%). Participants in the intervention group had greater reductions in waist circumference (p = .03) and greater improvements in self-reported vitality scores (p = .03) than the control group at the end of chemotherapy. Significant effects on biomarkers were not observed. CONCLUSIONS: A size acceptance weight management program is feasible during neoadjuvant chemotherapy among breast cancer patients and may have beneficial effects on waist circumference and patient vitality. TRIAL REGISTRATION: This study was registered as a clinical trial at www.clinicaltrials.gov (NCT00533338).

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy.

BACKGROUND: The current randomized trial examined the effects of a Tibetan yoga program (TYP) versus a stretching program (STP) and usual care (UC) on sleep and fatigue in women with breast cancer who were undergoing chemotherapy. METHODS: Women with stage (American Joint Committee on Cancer (AJCC) TNM) I to III breast cancer who were undergoing chemotherapy were randomized to TYP (74 women), STP (68 women), or UC (85 women). Participants in the TYP and STP groups participated in 4 sessions during chemotherapy, followed by 3 booster sessions over the subsequent 6 months, and were encouraged to practice at home. Self-report measures of sleep disturbances (Pittsburgh Sleep Quality Index), fatigue (Brief Fatigue Inventory), and actigraphy were collected at baseline; 1 week after treatment; and at 3, 6, and 12 months. RESULTS: There were no group differences noted in total sleep disturbances or fatigue levels over time. However, patients in the TYP group reported fewer daily disturbances 1 week after treatment compared with those in the STP (difference, -0.43; 95% confidence interval [95% CI], -0.82 to -0.04 [P = .03]) and UC (difference, -0.41; 95% CI, -0.77 to -0.05 [P = .02]) groups. Group differences at the other time points were maintained for TYP versus STP. Actigraphy data revealed greater minutes awake after sleep onset for patients in the STP group 1 week after treatment versus those in the TYP (difference, 15.36; 95% CI, 7.25-23.48 [P = .0003]) and UC (difference, 14.48; 95% CI, 7.09-21.87 [P = .0002]) groups. Patients in the TYP group who practiced at least 2 times a week during follow-up reported better Pittsburgh Sleep Quality Index and actigraphy outcomes at 3 months and 6 months after treatment compared with those who did not and better outcomes compared with those in the UC group. CONCLUSIONS: Participating in TYP during chemotherapy resulted in modest short-term benefits in sleep quality, with long-term benefits emerging over time for those who practiced TYP at least 2 times a week. Cancer 2018;124:36-45. © 2017 American Cancer Society.

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience.

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.

Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial.

OBJECTIVES: Sleep disturbances and fatigue are common in prostate cancer patients undergoing radiotherapy. Prior research suggests mind-body techniques may improve these outcomes. We conducted a randomized controlled trial of qigong/tai chi (QGTC) in men with prostate cancer undergoing radiotherapy. METHODS: Men with prostate cancer starting definitive radiation were randomized to 1 of 3 groups: (1) QGTC; (2) light exercise (LE); or (3) waiting list control. Sleep disturbances (Pittsburgh Sleep Quality Index) and fatigue (Brief Fatigue Inventory) were assessed at baseline, midway through radiotherapy (T2), during the last week of radiotherapy (T3), and at 1 (T4) and 3 months (T5) after the end of radiotherapy. Patients in the QGTC and LE groups attended three 40-minute classes per week throughout radiotherapy. RESULTS: Ninety patients were randomized to the 3 groups (QGTC = 26; LE = 26; waiting list control = 24). The QGTC group reported longer sleep duration midway through radiotherapy (QGTC = 7.01 h; LE = 6.42; WL = 6.50; P = .05), but this difference did not persist over time. There were no group differences in other domains of sleep or fatigue. Exploratory analyses conducted to examine the effect of health-related quality of life (Expanded Prostate Cancer Index Composite and American Urological Association Symptom score) on sleep and fatigue showed significant correlations across multiple domains. CONCLUSIONS: Qigong/tai chi during radiation for prostate cancer resulted in superior sleep duration midway through radiation, but this effect was not durable, and there were no differences in other domains of sleep or fatigue. Exploratory analysis demonstrated that both sleep and fatigue were highly correlated with prostate cancer-related physical symptoms. Future mind-body intervention studies should incorporate multimodal therapy focused on improving physical symptoms in this population.