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Completed

NCT Number: NCT06500858

MBC Physical Activity Study

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.

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Key information

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Receive a welcome package with exercise equipment

Health Promotion and Education

Other

Receive monthly newsletters

Internet-Based Intervention

Other

Receive access to online fitness buddy matching program

Physical activity

Other

Participate in a walking program

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Physical activity improvement

    Time frame: 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 outcomes

  1. Patient adherence

    Time frame: 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.

  2. Mean patients' minutes of activity

    Time frame: 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.

  3. Change in physical function

    Time frame: 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.

  4. Change in quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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