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Breast CancerNCT03760536

Get REAL and HEEL Research Program

An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Breast Cancer
What is being tested?
16-week Exercise Rehabilitation Program for Breast Cancer Survivors
How many people
35 participants
Where
1 siteUnited States
Study dates
20 Mar 2017to 12 Feb 2020
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • North Carolina Cancer Hospital

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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.

Conditions
Breast Cancer
Being tested
16-week Exercise Rehabilitation Program for Breast Cancer Survivors
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 16-week Exercise Rehabilitation Program for Breast Cancer SurvivorsBehavioural

    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.

Study groups in NCT03760536
Study groupRoleWhat they receive
16-week Exercise ProgramInterested 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.
Receives: Behavioral: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (21)

  1. Anthropometrics-Height

    Measure Height

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

  2. Anthropometrics-Weight

    Weight

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

  3. Anthropometrics-BMI

    Measure BMI

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

  4. Anthropometrics-Blood Pressure

    Measure blood pressure -- both systolic and diastolic

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

  5. Anthropometrics-Resting Heart Rate

    Measure Resting Heart Rate

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

  6. Body Composition

    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).

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

  7. Measure of muscle composition -- proportion of body fat to lean muscle mass

    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.

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

  8. Vascular Function

    XCEL Sphygmacor+USCOM

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

  9. Resting ECG

    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.

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

  10. Functional Tests

    6-minute walk

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

  11. Functional Tests

    Timed Up and Go

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

  12. Cognitive Testing

    Administer DKEFS

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

  13. Cognitive Testing

    Administer Digit Span

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

  14. Cognitive Testing

    Administer Sequencing

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

  15. Cognitive Testing

    Administer HVLT-R

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

  16. Cognitive Testing

    Administer TMT

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

  17. Cognitive Testing

    Administer NeuroCom balance test

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

  18. Muscle Strength and Power

    Isokinetic, isometric handgrip tests

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

  19. Blood Draw

    30 mL Blood draw for non-subset group

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

  20. Satisfaction with GR&H Questionnaire

    Administer Satisfaction with GR\&H Questionnaire

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

  21. Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only)

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study start20 Mar 2017
  3. Primary completion9 Mar 2019
  4. Study completion12 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
35 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760536
Sponsor's protocol ID
LCCC 1630
Status last verified
Sep 2021
First submitted
22 Oct 2018
Last updated
2 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35098347

  • 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.

    PubMed 34777343

  • 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.

    PubMed 34146655

Questions about this trial

What is this clinical trial studying?

An observational study of 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary exercise test with NIRS and PWA (vascular function) (time frame: Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03760536, which also lists 3 linked publications.

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 2 Sep 2021.

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Get REAL and HEEL Research Program (NCT03760536) | AzTrials