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Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
Sponsor: Northwestern University
Summary
The purpose of this study is to examine which of four components of a digital health intervention using an App and Fitbit meaningfully contribute to increased physical activity in Metastatic Breast Cancer Patients. Participants will be asked to: * Wear a Fitbit and use an app, use 0 to 3 other components for 24 weeks and attend 6 or 12 coaching coaching calls in the first 12 weeks to increase daily steps. * Complete a questionnaire at baseline, week 12 and week 24 * Complete functional performance test (FPT) via Zoom at baseline, week 12 and week 24 * Wear a research activity monitor (Accelerometer) for 7 days at baseline, week 12 and week 24
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2027-01-01
Completion Date
2031-06-15
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
Core Intervention
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.
EHR Integration (On v. Off)
Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.
Weekly Coaching
Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.
Social+ (on v. off)
Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.
Static Goal Setting
Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Bi-Weekly Coaching
Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Highly Tailored Goal Setting
Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.
Locations (1)
Northwestern University
Chicago, Illinois, United States