Optimizing a mHealth physical activity intervention with mindful awareness lessons in breast cancer survivors: Fit2ThriveMIND protocol

Fit2ThriveMIND is a theory-guided moderate to vigorous physical activity (MVPA) promotion trial guided by the Multiphase Optimization Strategy (MOST) framework to evaluate the efficacy of four intervention components for increasing MVPA among inactive, post-treatment breast cancer survivors (BCS; n = 304). All participants receive a core mHealth intervention, including a Fitbit and custom-built self-monitoring Fit2ThriveMIND smartphone application. Participants are randomized to one of 16 intervention conditions, reflecting every possible combination of the four intervention components, each of which has two levels (Yes v. No): 1) Buddy, 2) E-Coach, 3) General Mindfulness (MIND), 4) MVPA-guided mindfulness (PAMIND). The primary aim is to determine the individual and combined effects of the intervention components on accelerometer-assessed MVPA at 24-weeks (post-intervention) and 48-weeks follow-up. The secondary aim is to examine how changes in MVPA influence patient-reported outcomes, other intensity activities (light and sedentary), and sleep duration and quality. All components have a 24-week duration, except E-coaching, which includes “boosters” personalized to an individual's MVPA goal attainment during weeks 25–48. Fit2ThriveMIND represents the first systematic effort to use MOST to design an optimized mHealth MVPA intervention for BCS that incorporates mindfulness and tests a maintenance strategy. This trial will improve understanding of how to effectively and efficiently change and maintain MVPA among BCS to inform more effective and scalable interventions to improve health and disease outcomes. Clinical Trials Registration #NCT05931874.