MBC Physical Activity Study

Thomas Jefferson University

Status: Completed

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06500858

JT 41644 (Other Identifier)

2024-3107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Supportive care (virtual exercise sessions)

Experimental group

Description:

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.

Treatment:

Other: Exercise Intervention

Other: Exercise Intervention

Other: Questionnaire Administration

Other: Internet-Based Intervention

Other: Health Promotion and Education

Other: Exercise Intervention

Other: Physical Activity