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

NCT ID: NCT07313306

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Breast Cancer Metastatic Breast Cancer

Keywords

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Get Real and Heel (GRH) physical activity exercise quality of life social support

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

The Real and Heel (GRH)

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sasha Knowlton, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristen Jarman

Role: CONTACT

Phone: 919-984-0000

Email: [email protected]

Facility Contacts

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Sasha Knowlton

Role: primary

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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LCCC2513

Identifier Type: -

Identifier Source: org_study_id