Rationale and study protocol for a pilot study to determine the feasibility and acceptability of a tailored stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity

BACKGROUND: Despite similar incidence, age-adjusted breast cancer mortality remains higher among Black women compared to White women in the U.S. Racial disparities are also noted in survivorship-associated indicators (e.g., fatigue, cognition, quality of life). Black women also have a higher prevalence of obesity compared to White women, which may contribute to a higher incidence of obesity-associated cancers and poorer survivorship. Because current behavioral weight loss (BWL) interventions have been less effective for Black women, we built upon an existing culturally tailored BWL intervention to develop Survivors RESET, a program designed to promote weight loss among Black female breast cancer survivors with obesity and elevated stress. This pilot study will assess the feasibility and acceptability of Survivors RESET and measure changes in weight, allostatic load score, and patient reported outcomes. METHODS: For this single-arm study, Black women with obesity (n = 30) will be enrolled in a 16-session, culturally targeted, stress management-enhanced BWL intervention adapted to increase cancer-relevancy. Primary outcomes are feasibility and acceptability. We will also assess pre- to post-intervention changes in weight, allostatic load score, and patient reported outcomes (e.g., perceived stress, fatigue, cognition, quality of life). DISCUSSION: Our focus on culturally targeted, breast cancer specific stress management in a BWL trial offers a new approach to lifestyle interventions for breast cancer survivors which may lead to improved outcomes for Black women. If feasible and acceptable, this pilot study will support a future fully powered trial to test the efficacy of this novel intervention.