NCT07313306

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
23mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Jul 2028

Study Start

First participant enrolled

December 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

December 17, 2025

Last Update Submit

January 16, 2026

Conditions

Breast CancerMetastatic Breast Cancer

Keywords

Get Real and Heel (GRH)physical activityexercisequality of lifesocial support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Differences in quality of life - Functional Assessment of Cancer Therapy- Breast (The FACT-B)

    16 weeks

  • Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Physical Function

    16 weeks

  • Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Social Isolation

    16 weeks

  • Differences in social support

    16 weeks

Study Arms (1)

Metastatic breast cancer (MBC) receive Get Real and Heel (GRH)

EXPERIMENTAL

Participants will receive Get Real and Heel (GRH) exercise program.

Behavioral: The Real and Heel (GRH)

Interventions

The Real and Heel (GRH)BEHAVIORAL

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

Metastatic breast cancer (MBC) receive Get Real and Heel (GRH)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

lime

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Sasha Knowlton, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Jarman

CONTACT

919-984-0000jkristen@email.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 31, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)