Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
Fit2ThriveMB
2 other identifiers
interventional
224
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
Study Completion
Last participant's last visit for all outcomes
June 15, 2031
October 1, 2026
September 1, 2026
4 years
September 18, 2026
September 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Steps
The ActiGraph accelerometer will be used. Participants will wear the device during all waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip.
Baseline, 12 and 24 weeks
Secondary Outcomes (13)
ActiGraph measured MVPA
Baseline, 12 and 24 weeks
ActiGraph measured light activity
Baseline, 12 and 24 weeks
ActiGraph measured sedentary behavior
Baseline, 12 and 24 weeks
Godin Leisure Time Exercise Questionnaire
Baseline, 12 and 24 weeks
Short Physical Performance Battery (SPPB) Total Score
Baseline, 12 weeks, 24 weeks
- +8 more secondary outcomes
Study Arms (16)
1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
EXPERIMENTAL2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
EXPERIMENTAL3- Core, EHR, Weekly Coaching, Static Goal Setting
EXPERIMENTAL4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
EXPERIMENTAL5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
EXPERIMENTAL6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
EXPERIMENTAL7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
EXPERIMENTAL8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
EXPERIMENTAL9- Core, Weekly Coaching, Social+, Static Goal Setting
EXPERIMENTAL10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
EXPERIMENTAL11- Core, Weekly Coaching, Highly Tailored Goal Setting
EXPERIMENTAL12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
EXPERIMENTAL13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
EXPERIMENTAL14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
EXPERIMENTAL15- Core, Weekly Coaching, Static Goal Setting
EXPERIMENTAL16- Core, Bi-Weekly Coaching, Static Goal Setting
EXPERIMENTALInterventions
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.
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.
Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.
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.
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.).
Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
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.
Eligibility Criteria
You may qualify if:
- Female sex assigned at birth, age 18 years or older
- Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection.
- Self-report engagement in \<150 min/week of moderate to vigorous physical activity
- Ownership of an Android or iPhone with an up-to-date version of the operating system
- Internet access to complete assessments
- Fluency in spoken and written English
- Willingness to obtain medical clearance to participate.
You may not qualify if:
- Untreated brain metastases
- Breast cancer with metastases to only the axillary lymph nodes.
- Self-reported absolute contraindications to exercise (i.e., non-ambulatory, acute myocardial infarction, severe cognitive or functional impairment)
- Currently pregnant or plans to become pregnant
- Plans to move out of the United States in next 12 months
- Current enrollment in another dietary or physical activity trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 18, 2026
First Posted
September 25, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
June 15, 2031
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share