This randomized phase III trial studies physical activity in reducing functional health disparities in older stage I-III breast cancer survivors. Increased physical activity among older breast cancer survivors may help to improve functional and overall health status.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02763228.
PRIMARY OBJECTIVES:
I. To determine the effect of a refined and culturally-sensitive physical activity intervention on functional outcomes at 20 and 52 weeks among older breast cancer (BCa) survivors who are within five years of treatment completion for stage I-III BCa.
II. To examine whether race and socio-economic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks
III. To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes, preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.
IV. To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo supervised aerobic exercise over 40 minutes and resistance training over 20 minutes 3 times per week for 20 weeks. Patients then participate in regular exercise sessions on flexible schedule for 32 weeks.
GROUP II: Patients participate in structured health education and support group sessions over 60 minutes once per week for 20 weeks. Patients then participate in support group sessions for 32 weeks.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorCynthia Owusu
