RecruitingInterventional

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

NCT ID: NCT07313306Sponsor: UNC Lineberger Comprehensive Cancer CenterLast updated: 2026-01-20

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.

Arms & interventions

BehavioralThe 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).

Outcome measures

Primary

Feasibility of referral to Get Real and Heel
The proportion of consented patients who are successfully referred to the Get Real and Heel program and complete at least 24 sessions (32 total available; 2 sessions per week) in person.
Time frame: Up to 16 weeks

Secondary

Differences in quality of life - Functional Assessment of Cancer Therapy- Breast (The FACT-B)
Time frame: 16 weeks
Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Physical Function
Time frame: 16 weeks
Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Social Isolation
Time frame: 16 weeks
Differences in social support
Time frame: 16 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Recruiting

Sasha Knowlton · Contact

Sasha E Knowlton, MD · Principal Investigator