Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 10, 2020
Date Accepted: Feb 15, 2021
Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Study Design and Methods of the Fit2ThriveMB Pilot Trial
ABSTRACT
Background:
Increased incidence and life expectancy has resulted in a growing population of metastatic breast cancer patients. Metastatic breast cancer patients experience high rates of morbidity and premature mortality. Increased physical activity is consistently associated with improved health and disease outcomes among early stage survivors. However, there is a paucity of research on physical activity in metastatic breast cancer patients and existing physical activity interventions have exhibited low feasibility due to their focus on intense physical activity and/or requiring on-site visits. mHealth PA interventions may be particularly useful for metastatic breast cancer patients because they allow for remote monitoring which facilitates individual tailoring of physical activity reccomendations to patient’s abilities and may minimize participant burden. Yet, no studies have examined a mHealth PA intervention in metastatic breast cancer patients.
Objective:
We propose to address these critical research gaps by testing a highly tailored technology-supported intervention to promote physical activity of any intensity (i.e. light, moderate or vigorous) via increasing daily steps in metastatic breast cancer patients. The primary aim of this study is to test the feasibility and acceptability of the Fit2ThriveMB intervention. We will also examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom burden, quality of life and functional performance.
Methods:
The Fit2ThriveMB Trial is a two-armed pilot randomized controlled trial which will contrast the effects of a smartphone-delivered, home-based, physical activity intervention and an attention control education condition on physical activity and quality of life in low active female metastatic breast cancer patients. A subsample (n=25) will also complete functional performance measures. This innovative trial will recruit 50 participants who will be randomized into the intervention arm or control arm of the study. The intervention will last 12 weeks. The Fit2ThriveMB intervention consists of a Fitbit, coaching calls, and the Fit2ThriveMB smartphone app which provides self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app notifications, and a group message board. Assessments will occur at baseline and post-intervention.
Results:
The Fit2ThriveMB study is currently being conducted. The anticipated end date is February 2021.
Conclusions:
Data from this study will provide preliminary effect sizes to be used to assemble an intervention to be evaluated in a fully powered trial. These data will provide essential evidence to support the feasibility, acceptability, and health benefits of increasing physical activity in metastatic breast cancer patients using a technology-supported intervention, a scalable strategy that could be easily integrated into care to improve health and disease outcomes in this population. Clinical Trial: NCT04129346
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