Increasing exercise for people with metastatic breast cancer using the Get Real and Heel program

Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise

This project will try offering the Get Real and Heel (GRH) exercise program to people with metastatic breast cancer at UNC to see if it increases physical activity and improves symptoms and quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UNC Lineberger Comprehensive Cancer Center (other)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT07313306 on ClinicalTrials.gov

What this trial studies

This single-center feasibility intervention will invite adults with metastatic breast cancer receiving care at UNC to participate in 16 weeks of free, expert-led GRH classes that include aerobic, strength, balance, and flexibility training tailored to participants. Feasibility is defined as attending at least 24 of the 32 offered sessions, with electronic patient-reported outcomes collected at baseline and 16 weeks. Outcomes include FACT-B for breast cancer quality of life, PROMIS Physical Function and Social Isolation measures, and a modified Medical Outcomes Social Support Survey to capture social support and isolation. The study targets unmet exercise needs and uses existing UNC community resources to reduce barriers to participation and referral.

Who should consider this trial

Good fit: Adults (over 18) with a diagnosis of metastatic breast cancer within the past two years who are medically cleared for moderate-intensity exercise, receive ongoing cancer care at UNC, and can participate in English-language programming are ideal candidates.

Not a fit: Patients who are bed-bound, on hospice, have contraindications to exercise, or who have already participated in GRH since their metastatic diagnosis may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could help people with metastatic breast cancer become more active, improve physical function and quality of life, reduce fatigue, and lower social isolation.

How similar studies have performed: Exercise interventions in metastatic breast cancer have generally been safe and associated with improvements in function and quality of life, but community-based programs like GRH have been underused and not widely tested specifically in this population.

Eligibility criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subjects are willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
* Age \> 18 years at the time of consent.
* Diagnosis of metastatic breast cancer within two years of consent date
* Receives medical clearance from clinical team for moderate intensity exercise programming
* Indicates intent to receive ongoing cancer care at the enrolling institution
* English Speaking - program and measures are in English and not practicably translatable for a study this size.

Exclusion Criteria:

* Currently on hospice.
* Bed-bound status or other contraindication to exercise
* Participation in GRH since their diagnosis with MBC

Where this trial is running

Chapel Hill, North Carolina

• Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Sasha Knowlton, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Kristen Jarman

Conditions: Breast Cancer, Metastatic Breast Cancer, Get Real and Heel, physical activity, exercise, quality of life, social support