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

Abstract

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.

Advanced cancer patients in a randomized clinical trial of night-simulating eyeglasses observed to have a normal 24-h circadian rhythm during chemotherapy

“… 57 The lifestyle interventions at the Block Center may have contributed to the good condition of the patients, but the study was not intended or designed to make conclusions about this possibility. The analysis cannot determine whether participants improved their CO soon after beginning the chronomodulated chemotherapy and systematic supportive integrative treatment protocols, 58 – 60 or whether they simply maintained preexisting good CO throughout chemotherapy regimens. 31 …”

Integrative Cancer Therapies: Learning From COVID-19

“…Such multitargeted interventions have been described in the literature, [15][16][17][18] and one experimental study of such a system published in this journal even included remote delivery of lifestyle counseling using Facetime. 17 While in-person counseling has significant advantages, the safety and potential economy of telehealth consultations with integrative physicians, dietitians, and specialists in psychosocial oncology may allow for very relevant interventions, particularly for patients in treatment. Referrals to in-person therapies can be made for lower-risk patients, perhaps at locations outside the treating hospital if necessary.…”

Storying My Lifestyle Change: How Breast Cancer Survivors Experience and Reflect on Their Participation in a Pilot Healthy Lifestyle Intervention

“…The majority of structured programs target either dietary or physical activity changes (Demark-Wahnefried et al, 2012 ). However, in recent years there has been an increase in more integrative lifestyle interventions that target different mind-body factors with potential impacts on both weight-loss and quality of life such as motivation, self-efficacy, yoga, sleep, and meditation (Arun et al, 2017 ; Larkey et al, 2014 ; Lyman et al, 2018 ; Reeves et al, 2014 ). One comprehensive review on the effectiveness of such interventions identified several characteristics of more successful lifestyle trials (O’Connell et al, 2016 ).…”