This clinical trial tests the effect of a self-managed exercise program on joint pain (arthralgia) and adherence to aromatase inhibitor (AI) therapy in older breast cancer survivors. AIs are used as a type of hormone therapy for postmenopausal women who have hormone-dependent breast cancer and can cause joint pain. Many older survivors have age-related impairments that may increase treatment side effects and have a negative affect on quality of life which increases the risk of stopping treatments. A self-managed exercise and education program may help relieve arthralgia related to AI therapy and increase adherence in older breast cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03955627.
PRIMARY OBJECTIVES:
I. Test the effect of a pilot intervention on arthralgia and behavioral predictors for AI medication adherence (e.g., knowledge and self-efficacy).
II. Test the effect of a pilot intervention on adherence to aromatase inhibitors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive printed educational material describing hormonal therapy and a one-on-one exercise consultation with a trainer and attend a video-recorded orientation on study. Patients participate in virtual supervised exercise sessions over 60 minutes with educational discussions over 30 minutes twice a week for 8 weeks followed by at home physical activity sessions over 120-150 minutes 2-3 times a week for 8 weeks. Patients also receive resistance bands and ankle weights and coaching phone calls bimonthly during at home sessions. Additionally, patients undergo blood sample collection, physical function testing and monitor physical activity wearing an accelerometer throughout study.
ARM II: Patients receive printed educational material describing hormonal therapy and standard of care on study. Additionally, patients undergo blood sample collection, physical function testing and monitor physical activity wearing an accelerometer throughout study.
After completion of study intervention, patients are followed up at months 4, 6, and 12.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorShirley Bluethmann
