ABSTRACT
Purpose: The Cook & Move for Your Life randomized pilot study assessed the feasibility and relative efficacy of two dose levels of a remotely-delivered diet and physical activity (PA) intervention for breast cancer (BC) survivors. Methods: Women with a history of stage 0-III BC who were >60 days post-treatment, ate <5 servings per day of fruits/vegetables or engaged in <150 minutes per week of moderate to vigorous physical activity (MVPA), and had smartphone or computer access were enrolled. Participants were randomized to receive one of two doses of an online diet and PA didactic and experiential program, with outcomes measured at 6 months. The low-dose arm received a single 2-hour Zoom session delivered by a dietitian, a chef, a culinary educator, and an exercise physiologist;the high-dose arm received 12 2-hour Zoom sessions over 6 months. All participants received weekly motivational text messages, a Fitbit to self-monitor PA, and study website access. The primary objective was to evaluate overall feasibility based on accrual, adherence, and retention. Prespecified feasibility endpoints were 75% retention at 6 months and 60% of high-dose arm participants attending at least 8 of the 12 sessions. Secondary objectives were to compare high vs. low dose intervention effects on 6-month changes in fruit/vegetable servings per day (24-hour dietary recall), MVPA minutes per week (accelerometry), and blood and stool biomarkers.Results: From December 2019 to January 2021, 74 women were accrued. On average, women were 57.9 years old, 4.8 years post-diagnosis, with body mass index of 29.1 kg/m2 . Most were nonHispanic white (89.2%), 51.4% were diagnosed at stage I, and 40.5% were on endocrine therapy. Questionnaire and biospecimen data collection at 6-months were completed for 93.2% and 83.8% of the sample, respectively. In the low-dose arm (n=36), 94.4% of participants attended the single class, while in the high-dose arm (n=38) 84.2% of participants attended at least 8 of the 12 sessions live or via video archived on the website (mean 9.4 sessions). On average over the 6-month intervention period, participants responded to 71.5% of the text messages, 73.0% wore their Fitbit device ≥50% of the time, and 77.0% accessed the study website. Mean vegetable intake increased by 1 serving per day among women in the high-dose arm and decreased slightly among women in the low-dose arm (P=0.03). Changes in fruit/vegetable intake and MVPA varied little by arm. Blood and stool biomarker analyses are ongoing. Conclusion: We successfully conducted a remotely-delivered diet and PA intervention for BC survivors with high accrual, adherence, and retention during the COVID-19 pandemic. Women in the high-dose arm increased vegetable intake relative to the low-dose arm. Future research will refine and test the intervention in a larger and more diverse study population.