MBC Physical Activity Study

NCT06500858 | Completed

• 2 other identifiers: 2024-3107JT 41644
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient adherence

  At baseline and up to 6 weeks after initial post-assessment

• Mean patients' minutes of activity

  At baseline and up to 6 weeks after initial post-assessment

• Change in physical function

  At baseline and up to 6 weeks after initial post-assessment

• Change in quality of life

  At baseline and up to 6 weeks after initial post-assessment

Study Arms (1)

Supportive care (virtual exercise sessions)

EXPERIMENTAL

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: Exercise Intervention; Other: Health Promotion and Education; Other: Internet-Based Intervention; Other: Physical Activity; Other: Questionnaire Administration

Interventions

Exercise Intervention OTHER

Receive a welcome package with exercise equipment

Supportive care (virtual exercise sessions)

Health Promotion and Education OTHER

Receive monthly newsletters

Supportive care (virtual exercise sessions)

Internet-Based Intervention OTHER

Receive access to online fitness buddy matching program

Supportive care (virtual exercise sessions)

Physical Activity OTHER

Participate in a walking program

Supportive care (virtual exercise sessions)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (virtual exercise sessions)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Health Promotion; Educational Status; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: September 6, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)