Clinical trial · Interventional
MBC Physical Activity Study
A Tailored Physical Activity Program to Address Physical Inactivity Amongst Metastatic Breast Cancer Patients
- 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 clinical trial evaluates the impact of a tailored physical activity program on physical activity in patients with breast cancer that has spread from where it first started to other places in the body (metastatic). It has been shown that decreased physical activity contributes to poor performance and quality of life. Evidence has also shown that exercise could improve physical fitness, physical functioning, quality of life, and cancer-related fatigue, however, there is concern that it may not be available to those with physical limitations. The proposed physical activity program offers a comprehensive and individualized assessment for each metastatic breast cancer patient and includes a high quality, tailored exercise home-based program designed by an advanced qualified cancer exercise specialist. A tailored physical activity program may improve physical activity in metastatic breast cancer patients.
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 |
|---|---|---|---|
| Anatomic Stage IV Breast Cancer AJCC v8 | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Other | — | UNRESOLVED |
| Health Promotion and Education | Other | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Physical Activity | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (virtual exercise sessions)
- description
- The 2Unstoppable Strong program is 6 weeks with a weekly live via Zoom but also recorded exercise class. All participants will complete a phone screening (with 2Unstoppable) to determine eligibility and interest; a 30-minute assessment with the instructor over Zoom or FaceTime to review health history, concerns, \& limitations; then provide a signed Physician Release, a signed liability waiver and a completed health questionnaire.
- interventionNames
- Other: Exercise Intervention
- Other: Health Promotion and Education
- Other: Internet-Based Intervention
- Other: Physical Activity
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Physical activity improvement
- timeFrame
- At baseline and up to 6 weeks after initial post-assessment
- description
- Physical activity improvement will be measured by mean change in minutes of physical activity per week from baseline. Intervention effects will be estimated by using a follow-up indicator in longitudinal general estimating equations (GEE) linear regression model to test for a difference from zero for the follow-up indicator parameter estimate with a 2-sided Wald test at alpha=0.05 significance level along with a 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Aged 18 and older * Able to read and speak English * Diagnosed with metastatic breast cancer within 60 months of study enrollment * Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 * Insufficiently inactive defined as answer "no" to screening question "On average, do you engage in at least 75 minutes a week of vigorous activity (like jogging) or at least 150 minutes a week of moderate activity (like a brisk walk)?" * Able to comprehend and sign a written informed consent (no cognitive decline) * Willing to comply with all study procedures and be available for the duration of the study through at least week 2 of 2Unstoppable * Medically cleared by co-investigator or principal investigator (PI) to engage in aerobic and resistance exercise intervention * Access to a smart device and have an active wi-fi connection at home Exclusion Criteria: * Severe or unstable cardiopulmonary, metabolic, or renal disease * Unable to walk safely without physical assistance of another person or assistive device * Any condition that may limit the ability to comply with behavioral and physical recommendations of the virtual exercise program * Pregnancy
References
Publications (0)
Data not yet available