Get REAL and HEEL Research Program

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors

Study type: Observational

Funder types: Other

Identifiers

NCT03760536

LCCC 1630

Details and patient eligibility

About

The UNC Get REAL & HEEL (GR&H) program has provided after treatment support for women with a breast cancer diagnosis since 2006. The 16-week program includes an individualized training program and the opportunity to continue working out in the GR&H facilities at the conclusion of the 16-week program. The purpose of this protocol is to implement a research agenda at GR&H that will examine the efficacy of the program. The primary aim of this study is a pre-post test of the impact of the GR&H program (standardized combination of aerobic and resistance training) on VO2peak1,2. The secondary aims of this study are to evaluate quality of life as well as cardiorespiratory function (vascular health), physical function (muscular strength, body composition), cognition, balance, and patient-reported outcomes (fatigue, depression, anxiety, quality of life). Exploratory aims are focused on evaluating the impact of exercise on biomarkers: (1) aging - p16INK4a, (2) immune cell function - total leukocyte count, T and natural killer cells, monocytes, and neutrophils count and activity, and (3) circulating pro- and anti-inflammatory cytokines.

Full description

Objectives:

Primary:

Evaluate the impact of the Get REAL and HEEL research program (standardized combination of aerobic and resistance training) on change in V02peak from pre to post 16-week intervention.

Secondary:

Evaluate the impact of the GR&H program (standardized combination of aerobic and resistance training) on change in cardiorespiratory function, immunology, physical function parameters, cognition, balance, and patient-reported outcomes from pre to post 16-week intervention.

Evaluate changes in all measures annually over the 5 year follow-up period.

Report on enrollment, recruitment, and attrition.

Exploratory Objectives

The investigator's exploratory aims are focused on evaluating the impact of exercise on biomarkers: (1) aging - p16INK4a, (2) total leukocyte, lymphocyte (T cells and natural killer cells), monocyte and neutrophil counts and T cell proliferation assays, natural killer cytotoxicity assays, and cytokine production from stimulated neutrophils and monocytes, and (3) circulating pro- and anti-inflammatory cytokines.

OUTLINE:

Participants will complete pre-intervention assessments, questionnaires and blood draw at week 1 and 2 pre-intervention, followed by a 16-week aerobic and resistance training exercise program (intervention). Participants will complete assessments, questionnaires and blood draws at week 1 and 2 following the intervention and then again at 6 months and 12 months following intervention. Questionnaires only will be administered at year 2, 3,4 and 5 following intervention.

Enrollment: 35 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients will be eligible for this protocol if they have

• histologically confirmed early stage (non-metastatic) breast cancer
• and have recently (within 1 year) completed their initial treatment (they may continue to be on endocrine treatment).

No exclusions will be made based on ethnicity or race, although patients must be able to read and speak English.

Participants must provide IRB-approved signed written informed consent. The consent includes access to their medical records, including demographic and billing information, diagnoses, treatments, and laboratory results. Participants may also be asked to provide permission to contact their non-UNC doctors for additional medical record information, and may also require a medical release from various treating physicians.

Interested persons must agree to adhere to the 16-week GR&H protocol and complete all blood draws, assessments and questionnaires to the best of their ability. The informed consent will also include annual follow-up assessments and questionnaires for up to 5 years after they have completed the 16-week program.

Patients who are approached about participating in LCCC1630 and decline to do so are able to join GR&H as a supportive care program.

Exclusion criteria

Interested persons will be excluded from study participation if

• they do not have evidence of a cancer diagnosis or completion of surgery, radiation and/or chemotherapy treatment,
• or if they have previously completed the GR&H exercise program. Entirely at the discretion of GR&H investigators, physical function and other assessments conducted at baseline may also determine that a patient is not medically suitable for the GR&H protocol. Consented patients who are determined to be medically not suited for the GR&H protocol (unevaluable) will remain in the study for analyses comparing those who are evaluable with those who are not.

Trial design

35 participants in 1 patient group

16-week Exercise Program

Description:

Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.

Treatment:

Behavioral: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors