Breast CancerNCT07313306
Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
A study testing The Real and Heel (GRH) in people with Breast Cancer and Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- The Real and Heel (GRH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently on hospice.
- Bed-bound status or other contraindication to exercise
- Participation in GRH since their diagnosis with MBC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Sasha Knowlton
Sasha E Knowlton, MD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- The Real and Heel (GRH)
- Keywords
- Get Real and Heel (GRH), physical activity, exercise, quality of life, social support
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Real and Heel (GRH)Behavioural
The Get Real and Heel (GRH) program is a 16-week exercise intervention developed at the University of North Carolina at Chapel Hill (UNC).
| Study group | Role | What they receive |
|---|---|---|
| Metastatic breast cancer (MBC) receive Get Real and Heel (GRH) | Experimental | Participants will receive Get Real and Heel (GRH) exercise program. Receives: Behavioral: The Real and Heel (GRH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 Dec 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sasha Knowlton, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313306
- Sponsor's protocol ID
- LCCC2513
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
- ClinicalTrials.gov ID
- NCT07313306
- Acronym / sponsor ID
- LCCC2513
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- Get Real and Heel (GRH), physical activity, exercise, quality of life, social support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancer (MBC) receive Get Real and Heel (GRH) | Experimental | Behavioral: The Real and Heel (GRH)Participants will receive Get Real and Heel (GRH) exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Currently on hospice.
- Bed-bound status or other contraindication to exercise
- Participation in GRH since their diagnosis with MBC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Metastatic breast cancer (MBC) receive Get Real and Heel (GRH) |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sasha Knowlton, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Real and Heel (GRH) in people with Breast Cancer and Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Jarman (919-984-0000, jkristen@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of referral to Get Real and Heel (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.