Clinical trial · Interventional
Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
NCT04129346CI-TRIAL-00062117completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.
Conditions
Conditions (2)
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 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer.net app | Behavioral | — | UNRESOLVED |
| Fit2ThriveMB App | Behavioral | — | UNRESOLVED |
| Fitbit | Behavioral | — | UNRESOLVED |
| Healthy Living Coaching Calls | Behavioral | — | UNRESOLVED |
| Physical Activity Coaching Calls | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fit2ThriveMB
- description
- Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
- interventionNames
- Behavioral: Fit2ThriveMB App
- Behavioral: Fitbit
- Behavioral: Physical Activity Coaching Calls
- type
- ACTIVE_COMPARATOR
- label
- Healthy Living Control
- description
- Participants in the healthy living group will receive the American Society of Cancer Oncologists smartphone app, cancer.net. They will also receive calls during the intervention period and the Fitbit following completion of 12 week assessments
- interventionNames
- Behavioral: Healthy Living Coaching Calls
- Behavioral: Cancer.net app
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female; ≥18 years of age * Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify). * Fluent in spoken and written English * Own a smartphone * Have access to the internet to complete assessments * Self-report engaging in \<150 minutes of moderate to vigorous PA per week. Exclusion Criteria: * Untreated brain metastases * Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation * Current enrollment in another dietary or PA trial
References
Publications (2)
- DERIVEDPhillips SM, Starikovsky J, Solk P, Desai R, Reading JM, Hasanaj K, Wang SD, Cullather E, Lee J, Song J, Spring B, Gradishar W. Feasibility and preliminary effects of the Fit2ThriveMB pilot physical activity promotion intervention on physical activity and patient reported outcomes in individuals with metastatic breast cancer. Breast Cancer Res Treat. 2024 Nov;208(2):391-403. doi: 10.1007/s10549-024-07432-5. Epub 2024 Jul 16. PMID 39014267
- DERIVEDPhillips S, Solk P, Welch W, Auster-Gussman L, Lu M, Cullather E, Torre E, Whitaker M, Izenman E, La J, Lee J, Spring B, Gradishar W. A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 23;10(4):e24254. doi: 10.2196/24254. PMID 33890857