Breast Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORAL16-week Exercise Rehabilitation Program for Breast Cancer Survivors
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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary exercise test with NIRS and PWA (vascular function) | Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention | The Cardiopulmonary Exercise Test (CPET) with NIRS and PWA will be used to measure peak oxygen content (VO2peak), tissue oxygen saturation and pulse wave analysis during this symptom-limited exercise test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometrics-Weight | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | Weight |
| Anthropometrics-BMI | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | Measure BMI |
| Anthropometrics-Blood Pressure | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | Measure blood pressure -- both systolic and diastolic |
| Anthropometrics-Resting Heart Rate | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | Measure Resting Heart Rate |
| Body Composition | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post-intervention, 12 months post-intervention | DEXA -- Body Composition will be perfomed using a Hologic (Discovery W) Dual X-ray Absorptiometry (DEXA) located in the EORL. Total body weight-mass (BW) and compositional aspects of lean body mass (LBM), fat tissue mass (FM), and percentage body fat (% BF) will be examined using standard DEXA screening procedures. The BW will be measured using a high grade analytical balance-scale (accuracy ± 10 grams). |
| Measure of muscle composition -- proportion of body fat to lean muscle mass | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | Ultrasound -- LogicView™ software (General Electric Company, Milwaukee, WI, USA) will be used to generate real-time panoramic cross-sectional images of the VL. Three panoramic scans at a gain of 50dB and a depth of 5.0 cm. All image analyses will be completed using Image-J software (version 1.46r, National Institutes of Health, USA) with each image area individually scaled from pixels to centimeters via the straight-line function. The polygon function will be used to determine the CSA of the VL by selecting a region including mostly muscle and minimal surrounding fascia. Greater EI values represent greater fibrous (non-muscular) composition. |
| Vascular Function | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | XCEL Sphygmacor+USCOM |
| Anthropometrics-Height | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | Measure Height |
| Functional Tests | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | 6-minute walk |
| Cognitive Testing | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | Administer DKEFS |
| Muscle Strength and Power | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | Isokinetic, isometric handgrip tests |
| Blood Draw | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | 30 mL Blood draw for non-subset group |
| Satisfaction with GR&H Questionnaire | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | Administer Satisfaction with GR&H Questionnaire |
| Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only) | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | Cannulated, 3 blood draws over course of 45 minute visit. 50 mL total collected pre-intervention and post intervention; 30 mL total collected at 6 months and 12 months post-intervention |
| Resting ECG | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | Resting electrocardiogram -- Individual wave/complex/intervals components and overall ECG tracings will be assessed using a 12-lead ECG. The study Cardiologist will review each report individually at baseline prior to the Cardiopulmonary Exercise Test for evidence of overt cardiac dysfunction and will deem the potential study participant appropriate/not appropriate for exercise testing. |
Countries
United States
Outcome results
None listed