Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients

Part of paid clinical trials in Chicago, Illinois.

Sponsor: Northwestern University
Study ID: NCT07840599
Status: Not Yet Recruiting

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Conditions

Metastatic Breast Cancer
Metastatic Breast Cancer (MBC)
Metastatic Breastcancer

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Core Intervention — BEHAVIORAL
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.
EHR Integration (On v. Off) — BEHAVIORAL
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 — BEHAVIORAL
Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.
Social+ (on v. off) — BEHAVIORAL
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 — BEHAVIORAL
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 — BEHAVIORAL
Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Highly Tailored Goal Setting — BEHAVIORAL
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.

Study Details

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 Dates

First listed: Sep 25, 2026
Start date: Jan 1, 2027
Status verified: Sep 2026
Primary completion: Jan 1, 2031
Completion: Jun 15, 2031

Study Design

Enrollment: 224 participants (estimated)
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Arms

Experimental: 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
Experimental: 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
Experimental: 3- Core, EHR, Weekly Coaching, Static Goal Setting
Experimental: 4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
Experimental: 5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
Experimental: 6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
Experimental: 7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
Experimental: 8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
Experimental: 9- Core, Weekly Coaching, Social+, Static Goal Setting
Experimental: 10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
Experimental: 11- Core, Weekly Coaching, Highly Tailored Goal Setting
Experimental: 12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
Experimental: 13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
Experimental: 14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
Experimental: 15- Core, Weekly Coaching, Static Goal Setting
Experimental: 16- Core, Bi-Weekly Coaching, Static Goal Setting