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).

Characteristics and Outcomes of Psychology Referrals in a Palliative Care Department.

CONTEXT: Psychologists can provide unique contributions to interdisciplinary palliative care. Despite research indicating high distress in palliative care cancer patients, little has been reported regarding the feasibility and practice of psychology in this setting. OBJECTIVES: To review the integration of clinical psychology practice in a palliative care department at a major comprehensive cancer center. METHODS: Retrospective chart review of 1940 unique cancer patients (6451 total patient contacts) referred for psychology services provided by clinical psychologists in palliative care from September 1, 2013 to February 29, 2016. RESULTS: Psychologists provided services to 1644 inpatients (24% of palliative care inpatients) and 296 outpatients (19% of palliative care outpatients). Most of them (85%) received services in the inpatient setting. Most patients were females (57%) and white (68%) with a variety of cancer diagnoses. Adjustment disorders were the most prevalent in both settings with significant differences in other Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnoses by service location (P < 0.0001). Psychological assessment (86%) and supportive expressive counseling (79%) were the most frequent services provided in the initial consult. Duration of initial visit was significantly longer in outpatient (median 60 minutes) compared with inpatient setting (median 40 minutes) (P < 0.0001). No significant differences were noted between settings regarding the median number of counseling sessions per patient; however, most (70%) only received one or two sessions. Over time, total patient encounters increased in the inpatient setting (P < 0.0001), whereas session lengths in both settings significantly decreased (P < 0.0001). CONCLUSION: Palliative care psychology services successfully integrated into an interdisciplinary palliative care department and rapidly grew in both inpatient and outpatient settings.

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.