MBC Physical Activity Study
NCT Number: NCT06500858
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Breast Carcinoma
Interventions: OTHER: Exercise Intervention|OTHER: Exercise Intervention|OTHER: Exercise Intervention|OTHER: Health Promotion and Education|OTHER: Internet-Based Intervention|OTHER: Physical Activity|OTHER: Questionnaire Administration
Sponsor: Thomas Jefferson University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-10-30
Locations: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States

Summary:
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.

Primary Outcome Measures: Physical activity improvement, 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., At baseline and up to 6 weeks after initial post-assessment
Secondary Outcome Measures: Patient adherence, GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling., At baseline and up to 6 weeks after initial post-assessment|Mean patients' minutes of activity, GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling., At baseline and up to 6 weeks after initial post-assessment|Change in physical function, GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling., At baseline and up to 6 weeks after initial post-assessment|Change in quality of life, GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling, At baseline and up to 6 weeks after initial post-assessment