Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2024-09-06
2025-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Exercise Intervention
Receive a welcome package with exercise equipment
Exercise Intervention
Participate in virtual-exercise sessions
Exercise Intervention
Receive access to optional drop-in classes
Health Promotion and Education
Receive monthly newsletters
Internet-Based Intervention
Receive access to online fitness buddy matching program
Physical Activity
Participate in a walking program
Questionnaire Administration
Ancillary studies
Interventions
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Exercise Intervention
Receive a welcome package with exercise equipment
Exercise Intervention
Participate in virtual-exercise sessions
Exercise Intervention
Receive access to optional drop-in classes
Health Promotion and Education
Receive monthly newsletters
Internet-Based Intervention
Receive access to online fitness buddy matching program
Physical Activity
Participate in a walking program
Questionnaire Administration
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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JT 41644
Identifier Type: OTHER
Identifier Source: secondary_id
2024-3107
Identifier Type: -
Identifier Source: org_study_id
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