MBC Physical Activity Study

Not Applicable

Recruiting

• Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma
• Interventions: Other: Exercise Intervention; Other: Health Promotion and Education; Other: Internet-Based Intervention; Other: Physical Activity; Other: 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...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-09-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Female
• Aged 18 and older
• Able to read and speak English
• Diagnosed with metastatic breast cancer within 60 months of study enrollment
• Receiving treatment at the Sidney Kimmel Caner Center (SKCC) in Center City, New Jersey, Northeast, Abington or Methodist Hospital
• 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

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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

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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 ...

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