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. 2025 Sep:156:108038.
doi: 10.1016/j.cct.2025.108038. Epub 2025 Jul 31.

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

Melanie Wolter  1 , Jean M Reading  2 , Payton Solk  1 , Julia Starikovsky  1 , Kristina Hasanaj  1 , Shirlene D Wang  1 , Juned Siddique  1 , Bruriah Horowitz  3 , Bonnie Spring  1 , Lillian B Carden  1 , Rina Fox  4 , Christina Sauer  3 , Hannah Freeman  1 , Julia Frey  1 , David Victorson  3 , Siobhan M Phillips  5
Affiliations

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

Melanie Wolter et al. Contemp Clin Trials. 2025 Sep.

Abstract

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.

Keywords: Breast cancer survivors; Mindfulness training; Multiphase optimization strategy; Physical activity; Technology.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.. Fit2ThriveMIND Study Conceptual Model.
This model details how we hypothesize each intervention component influences MVPA. MVPA= moderate to vigorous physical activity.
Figure 2.
Figure 2.. Fit2ThriveMIND App.
This figure shows screenshots from Fit2ThriveMIND app home screen and from each intervention component’s (Buddy, E-coach, MIND, PAMIND) app msodule.
See this image and copyright information in PMC

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