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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: The Real and Heel (GRH)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Jarman; Phone Number: 919-984-0000; Email: jkristen@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
      • Contact: Sasha Knowlton
      • Principal Investigator: Sasha E Knowlton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metastatic breast cancer (MBC) receive Get Real and Heel (GRH); Participants will receive Get Real and Heel (GRH) exercise program.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in quality of life - Functional Assessment of Cancer Therapy- Breast (The FACT-B)	Differences in quality of life will be measured from the baseline (start of Get Real and Heel program) and post-16-week follow-up Functional Assessment of Cancer Therapy- Breast (The FACT-B) scores. The FACT-B is a breast-cancer specific survey consisting of 37 questions regarding quality of life over the past 7 days. Total scores range 0-148. Higher scores indicate lower health-related quality of life.	16 weeks
Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Physical Function	Differences in quality of life will be measured from the baseline (start of Get Real and Heel program) and post-16-week follow-up Patient Reported Outcomes Measurement Information System (PROMIS) -Physical Function 8c scores. The PROMIS Physical Function 8c asks about physical function over a 7-day period and is recommended to assess tolerance to drug therapy in the cancer population. The raw scores are then converted to a T-score, with higher scores indicating better function.	16 weeks
Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Social Isolation	Differences in quality of life will be measured from the baseline (start of Get Real and Heel program) and post-16-week follow-up Patient Reported Outcomes Measurement Information System (PROMIS) -Social Isolation scores. The PROMIS Social Isolation survey asks about feelings of disconnection or exclusion from others where a T-score is utilized as a summary measure, with higher values indicating more social isolation	16 weeks
Differences in social support	Differences in social support will be measured from the baseline (start of GRH program) and post-16-week follow-up modified Medical Outcomes Social Support (mMOS-SS) scores. The mMOS-SS is an eight-item questionnaire asks about emotional and tangible social support that has been validated in the cancer population, including breast cancer, with a range of 8 to 40, with higher scores indicating more social support.	16 weeks

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Sasha Knowlton, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; exercise; quality of life; social support; Get Real and Heel (GRH)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity; lime
• Other Study ID Numbers: LCCC2513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No