Get REAL and HEEL Research Program

NCT03760536 | Completed

• 1 other identifier: LCCC 1630
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary exercise test with NIRS and PWA (vascular function)

  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.

  Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention

Secondary Outcomes (21)

• Anthropometrics-Height

  Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention

• Anthropometrics-Weight

  Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention

• Anthropometrics-BMI

  Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention

• Anthropometrics-Blood Pressure

  Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention

• Anthropometrics-Resting Heart Rate

  Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention

Study Arms (1)

16-week Exercise Program

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.

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

Interventions

16-week Exercise Rehabilitation Program for Breast Cancer Survivors BEHAVIORAL

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.

16-week Exercise Program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants with confirmed early-stage breast cancer will be screened through a review of daily clinic schedules for patients seen at the North Carolina Cancer Hospital. Patients must have recently completed their initial treatment (be within one year of completion).

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• Wagoner CW, Lee JT, Hanson ED, Kerr ZY, Nyrop KA, Muss HB, Battaglini CL. Baseline fatigue in early breast cancer survivors: understanding its prevalence in community-based exercise. Support Care Cancer. 2022 May;30(5):4407-4416. doi: 10.1007/s00520-021-06776-8. Epub 2022 Jan 31.

  PMID: 35098347 DERIVED

• Bartlett DB, Hanson ED, Lee JT, Wagoner CW, Harrell EP, Sullivan SA, Bates LC, Alzer MS, Amatuli DJ, Deal AM, Jensen BC, MacDonald G, Deal MA, Muss HB, Nyrop KA, Battaglini CL. The Effects of 16 Weeks of Exercise Training on Neutrophil Functions in Breast Cancer Survivors. Front Immunol. 2021 Oct 27;12:733101. doi: 10.3389/fimmu.2021.733101. eCollection 2021.

  PMID: 34777343 DERIVED

• Hanson ED, Bates LC, Harrell EP, Bartlett DB, Lee JT, Wagoner CW, Alzer MS, Amatuli DJ, Jensen BC, Deal AM, Muss HB, Nyrop KA, Battaglini CL. Exercise training partially rescues impaired mucosal associated invariant t-cell mobilization in breast cancer survivors compared to healthy older women. Exp Gerontol. 2021 Sep;152:111454. doi: 10.1016/j.exger.2021.111454. Epub 2021 Jun 16.

  PMID: 34146655 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw for p16 analysis and immune/inflammatory parameters

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Claudio L Battaglini, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Kirsten Nyrop

  UNC Lineberger Comprehensive Cancer Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 30, 2018
• Study Start: March 20, 2017
• Primary Completion: March 9, 2019
• Study Completion: February 12, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

US (1)