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

January 16, 2026 updated by: UNC Lineberger Comprehensive Cancer Center
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 16 weeks
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)
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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