MBC Physical Activity Study
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast Carcinoma
- Interventions
- Other: Exercise InterventionOther: Health Promotion and EducationOther: Internet-Based InterventionOther: Physical ActivityOther: Questionnaire Administration
- Registration Number
- NCT06500858
- Lead Sponsor
- Thomas Jefferson University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive care (virtual exercise sessions) Exercise Intervention Patients receive a welcome package with exercise equipment and participate in virtual-exercise sessions over 60-90 minutes weekly for 6 weeks. Participants are also receive access to optional drop-in classes, monthly newsletters and online fitness buddy matching program and are encouraged to participate in a walking program on study. Supportive care (virtual exercise sessions) Health Promotion and Education Patients receive a welcome package with exercise equipment and participate in virtual-exercise sessions over 60-90 minutes weekly for 6 weeks. Participants are also receive access to optional drop-in classes, monthly newsletters and online fitness buddy matching program and are encouraged to participate in a walking program on study. Supportive care (virtual exercise sessions) Internet-Based Intervention Patients receive a welcome package with exercise equipment and participate in virtual-exercise sessions over 60-90 minutes weekly for 6 weeks. Participants are also receive access to optional drop-in classes, monthly newsletters and online fitness buddy matching program and are encouraged to participate in a walking program on study. Supportive care (virtual exercise sessions) Physical Activity Patients receive a welcome package with exercise equipment and participate in virtual-exercise sessions over 60-90 minutes weekly for 6 weeks. Participants are also receive access to optional drop-in classes, monthly newsletters and online fitness buddy matching program and are encouraged to participate in a walking program on study. Supportive care (virtual exercise sessions) Questionnaire Administration Patients receive a welcome package with exercise equipment and participate in virtual-exercise sessions over 60-90 minutes weekly for 6 weeks. Participants are also receive access to optional drop-in classes, monthly newsletters and online fitness buddy matching program and are encouraged to participate in a walking program on study.
- Primary Outcome Measures
Name Time Method Physical activity improvement At baseline and up to 6 weeks after initial post-assessment 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.
- Secondary Outcome Measures
Name Time Method Mean patients' minutes of activity At baseline and up to 6 weeks after initial post-assessment 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.
Patient adherence At baseline and up to 6 weeks after initial post-assessment 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.
Change in physical function At baseline and up to 6 weeks after initial post-assessment 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.
Change in quality of life At baseline and up to 6 weeks after initial post-assessment 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
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States