Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)

PRIMARY OBJECTIVES:

I. Compare the relative efficacy of tai chi and strength training to prevent falls in female
cancer survivors.

II. Determine the mechanism by which tai chi and strength training each reduces the risk of
falls.

III. Determine how well the benefits of each intervention persist after structured training
stops.

SECONDARY OBJECTIVES:

I. Quantify and compare the relative efficacy of tai chi and resistance exercise on
biomarkers common to both cancer progression and cardiovascular disease (CVD) in women
cancer survivors. (Optional ancillary study) II. Quantify and compare the relative efficacy
of tai chi and resistance exercise on biomarkers unique to CVD in women cancer survivors.
(Optional ancillary study) III. Determine the influence of initial and changes in adiposity
on changes in biomarkers from exercise. (Optional ancillary study) IV. Explore the effects
of exercise training on a biomarker of accelerated aging in women cancer survivors.
(Optional ancillary study)

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients attend strength training classes for 1 hour 2 days per week.

ARM II: Patients attend tai chi classes for 1 hour 2 days per week.

ARM III: Patients attend supervised stretching and relaxation classes for 1 hour 2 days per
week.

In all arms, treatment continues for 6 months.

After completion of study treatment, patients are followed up for 6 months.

Inclusion Criteria:

- Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord
(confirmed by patient self-report on the Health History Questionnaire; if patient is
unable to confirm either the site of her cancer or that her stage of cancer is <
stage IV, we will send a letter to her physician to confirm this criterion)

- Completed chemotherapy > 3 months prior to enrollment and no concurrent adjuvant
therapy other than hormone manipulation therapy for breast cancer (confirmed by
patient self-report on the Health History Questionnaire; if patient is unable to
confirm whether or not she completed chemotherapy 3 months prior to enrollment, we
will send a letter to her physician to confirm eligibility on this criterion)

- Postmenopausal (confirmed by self-report on the Health History Questionnaire;
menopausal status could also be confirmed by a recent [< 6 months from enrollment]
laboratory report documenting serum follicle-stimulating hormone (FSH) > 30 milli
international units per milliliter (mIU/ml) and/or serum estradiol < 30 pg/ml)

- Currently underactive (< 60 minutes of moderate intensity exercise per week in the
last month) (confirmed by self-report on the Health History Questionnaire)

Exclusion Criteria:

- Cognitive difficulties that preclude answering the survey questions, participating in
the exercise classes or performance tests, or providing informed consent (confirmed
by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone)

- A medical condition, movement or neurological disorder, or medication use that
contraindicates participation in moderate intensity exercise (confirmed by
self-report on the Health History Questionnaire, and by physician clearance; if in
the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone,
contraindications other than those identified by the patient or physician are
present, she may consider the participant ineligible)