GRH for Breast Cancer

Overseen By Kristen Jarman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Hospice, Bed-bound, Recent GRH participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special exercise program, Get Real and Heel (GRH), can help people with metastatic breast cancer (MBC) become more active. The researchers aim to determine if this program can boost well-being, improve physical function, and reduce feelings of isolation. Participation may enhance quality of life and ease cancer symptoms. Candidates may be suitable if diagnosed with metastatic breast cancer within the last two years and have received medical clearance for moderate exercise. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve support for others with MBC.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Get Real and Heel (GRH) program is safe for patients with metastatic breast cancer?

Research has shown that the Get Real and Heel (GRH) program has been helping people with breast cancer since 2006. This program supports those with metastatic breast cancer (MBC) by encouraging increased physical activity. While specific side effects from this program are not documented, exercise programs like GRH are generally well-tolerated. They aim to enhance quality of life, physical abilities, and social connections. The long-term use of GRH indicates its safety for participants, as it has been offered as support after treatment for many years. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for metastatic breast cancer, which often includes chemotherapy, hormone therapy, and targeted therapies, Get Real and Heel (GRH) is unique because it focuses on an exercise program. Researchers are excited about this approach because it emphasizes physical activity as a potential way to improve quality of life and possibly impact the progression of the disease. By integrating exercise into cancer care, GRH could offer a complementary strategy that enhances traditional treatments, potentially reducing side effects and boosting patients' overall well-being.

What evidence suggests that the Get Real and Heel (GRH) program is effective for increasing physical activity in metastatic breast cancer patients?

Research has shown that exercise programs like Get Real and Heel (GRH), which participants in this trial will receive, might improve the quality of life for people with metastatic breast cancer (MBC). Many with MBC often experience a decline in physical abilities and quality of life. Exercise can help by increasing physical activity, providing social support, and reducing feelings of isolation. Although specific data on GRH's effects on MBC is limited, exercise is generally considered helpful for managing symptoms and enhancing overall well-being in cancer patients. The GRH program aims to address unmet exercise needs, potentially leading to better symptom management and improved daily life. ^{1 4 6 7 8}

Who Is on the Research Team?

Sasha Knowlton, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic breast cancer diagnosed within the last two years. Participants must be able to understand English, give informed consent, plan to continue cancer care at the enrolling institution, and get medical clearance for moderate exercise.

Inclusion Criteria

I am willing and able to follow the study's procedures.

I am over 18 years old.

I was diagnosed with metastatic breast cancer in the last two years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Get Real and Heel (GRH) exercise program, which includes aerobic, strength, balance, and flexibility training tailored to participant needs

16 weeks

32 sessions (in-person)

Follow-up

Participants are monitored for changes in quality of life, physical functioning, fatigue, and social isolation after completing the exercise program

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Real and Heel (GRH)

Trial Overview

The study tests if a community-based exercise program called Get Real and Heel (GRH) can increase physical activity in patients with metastatic breast cancer. It aims to improve well-being, quality of life, physical function, social support, and reduce isolation.

How Is the Trial Designed?

Group I: Metastatic breast cancer (MBC) receive Get Real and Heel (GRH) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07313306

Feasibility of Symptom Management for Patients With ...

This study will examine unmet exercise needs among patients with metastatic breast cancer (MBC) at UNC and assess whether participation in Get ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12200229/

Real-world treatment patterns and outcomes of patients with ...

In this sample of HR+/HER2-low mBC patients, most patients switched to CT after two lines of therapy with a median rwPFS shorter than 10 months.

3.

ctv.veeva.com

ctv.veeva.com/study/feasibility-of-symptom-management-for-patients-with-metastatic-breast-cancer-to-increase-exercise

Feasibility of Symptom Management for Patients With ...

Patients with MBC are living longer due to improved treatments, yet up to 92% experience functional decline and reduced quality of life.

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e18871

Real-world clinical outcomes in patients (pts) with HR+/HER2

This study describes real-world outcomes in pts with HR+/HER2- mBC initiating CT or previously treated with CT in the US.

5.

esmoopen.com

esmoopen.com/article/S2059-7029(24)01460-1/fulltext

Real-world treatment patterns and outcomes in patients ...

The 5-year relative survival for locally advanced HR+/HER2− BC is 100%, and it declines to 35% for distant metastatic disease. ... 2. National ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12188612/

Assessment of the functional and health‑related needs ...

Patients with new or recurrent metastatic breast cancer face health-related issues including sedentary behavior, poor diet, and limitations including pain and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03760536

NCT03760536 | Get REAL and HEEL Research Program

The UNC Get REAL & HEEL (GR&H) program has provided after treatment support for women with a breast cancer diagnosis since 2006.

8.

clin.larvol.com

clin.larvol.com/trial-detail/NCT07313306

Feasibility of Symptom Management for Patients With ...

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 ...