NCT07313306

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will examine unmet exercise needs among patients with metastatic breast cancer (MBC) at UNC and assess whether participation in Get Real and Heel (GRH) can increase physical activity. The proposed research aims to improve multiple domains of well-being, quality of life, physical function, social support and reduce social isolation through a community based exercise intervention. By leveraging underutilized University of North Carolina Chapel Hill (UNC) resources, this work seeks to reduce barriers to accessibility, awareness, and appropriateness of exercise programming for this underserved population. Findings will help close the gap between patients' exercise needs, interest, and participation, with potential benefits for symptoms, functioning, and quality of life.

Detailed description

Patients with MBC are living longer due to improved treatments, yet up to 92% experience functional decline and reduced quality of life. Exercise is a recommended, safe, and effective intervention for improving function, strength, fitness, and quality of life, but most patients do not meet guidelines. At UNC, a recent needs-assessment survey study of MBC patients (n=50) found that 52% were sedentary, although 72% believed increased exercise would improve treatment tolerance. GRH, established in 2006, offers 16 weeks of free, expert-led exercise including aerobic, strength, balance, and flexibility training tailored to participant needs. Despite its availability, only 4% of surveyed patients had been referred. This study will evaluate the feasibility of implementing GRH for all MBC patients at UNC and assess its impact on quality of life, physical functioning, fatigue, and social isolation. Feasibility will be defined as attending ≥24 of 32 sessions. Patient-reported outcomes including Functional Assessment of Cancer Therapy- Breast (FACT-B), Patient-Reported Outcomes Measurement Information System (PROMIS) -Physical Function, the modified Medical Outcomes Social Support Survey, and PROMIS Social Isolation-will be collected electronically at baseline and at 16 weeks.

Conditions

• Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	The Real and Heel (GRH)	The Get Real and Heel (GRH) program is a 16-week exercise intervention developed at the University of North Carolina at Chapel Hill (UNC).

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-12-31
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States