IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods

Background: African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS. Methods: This is a mixed-methods study that includes a randomized-controlled trial, “IMPROVE”, to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms. Discussion: Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.