Status:
COMPLETED
Get REAL and HEEL Research Program
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
All Genders
21+ years
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 t...
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 interve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 12 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03760536
Start Date
March 20 2017
End Date
February 12 2020
Last Update
September 2 2021
Active Locations (1)
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1
North Carolina Cancer Hospital
Chapel Hill, North Carolina, United States, 27599