Clinical trial · Interventional
Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breastcancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer (MBC) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bi-Weekly Coaching | Behavioral | — | UNRESOLVED |
| Core Intervention | Behavioral | — | UNRESOLVED |
| EHR Integration (On v. Off) | Behavioral | — | UNRESOLVED |
| Highly Tailored Goal Setting | Behavioral | — | UNRESOLVED |
| Social+ (on v. off) | Behavioral | — | UNRESOLVED |
| Static Goal Setting | Behavioral | — | UNRESOLVED |
| Weekly Coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (16)
- type
- EXPERIMENTAL
- label
- 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
- interventionNames
- Behavioral: Core Intervention
- Behavioral: EHR Integration (On v. Off)
- Behavioral: Weekly Coaching
- Behavioral: Social+ (on v. off)
- Behavioral: Highly Tailored Goal Setting
- type
- EXPERIMENTAL
- label
- 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
- interventionNames
- Behavioral: Core Intervention
- Behavioral: EHR Integration (On v. Off)
- Behavioral: Social+ (on v. off)
- Behavioral: Bi-Weekly Coaching
- Behavioral: Highly Tailored Goal Setting
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available