Get REAL and HEEL Research Program

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.

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.