MBC Physical Activity Study

A Tailored Physical Activity Program to Address Physical Inactivity Amongst Metastatic Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Exercise Intervention; Other: Exercise Intervention; Other: Exercise Intervention; Other: Health Promotion and Education; Other: Internet-Based Intervention; Other: Physical Activity

Detailed Description

This single-arm study aims to evaluate the impact of participation in a physical rehabilitation program tailored for metastatic breast cancer (MBC) patients on physical activity, quality of life (QOL), and patient satisfaction.

The study will enroll approximately 50 female patients aged 18 or older who were initially diagnosed with metastatic disease within 60 months of enrollment and are continuing treatment for metastatic disease at Jefferson Health. Enrollment will be balanced at an approximate 1:1 ratio, including 25 African American or Hispanic (non-White) patients and 25 White Caucasian patients who meet eligibility criteria during the 24-month study period.

The primary goal is to develop a physical activity program that addresses a key social determinant of health-physical inactivity-particularly among women of color with MBC. The study will further assess the impact of this program on physical activity, physical function, and quality of life.

The proposed program will provide a comprehensive, individualized assessment for each participant and include a high-quality, home-based exercise regimen directed by an advanced cancer exercise specialist.

Intervention:

A virtual program through 2Unstoppable will be offered. This 6-week, small-group program combines cardio and strength training to help women with metastatic cancer safely and confidently engage in physical activity in a supportive environment. The program meets exercise recommendations from the American Cancer Society (ACS) and the American College of Sports Medicine (ACSM) for cancer patients and survivors and is led by an advanced cancer exercise specialist.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (virtual exercise sessions); 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.

Other: Questionnaire Administration; Ancillary studies; Other: Exercise Intervention; Receive a welcome package with exercise equipment; Other: Exercise Intervention; Participate in virtual-exercise sessions; Other: Exercise Intervention; Receive access to optional drop-in classes; Other: Health Promotion and Education; Receive monthly newsletters; Other: Internet-Based Intervention; Receive access to online fitness buddy matching program; Other: Physical Activity; Participate in a walking program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Health Education; Exercise; Educational Status; Health Promotion
• Other Study ID Numbers: 2024-3107; JT 41644 (Other Identifier: JeffTrial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No