This clinical trial evaluates how manipulating the time of day (AM or PM) that exercise is performed works in breast cancer survivors on chemotherapy. Breast cancer chemotherapy leads to significant declines in physical function and adversely affects independence/time to return to activities of daily living, and quality of life (QoL). Functional capacity, independence, and QoL, are top reported concerns among breast cancer survivors after diagnosis Exercise may serve as an effective strategy to diminish declines in physical function, independence, and QoL during chemotherapy, while also attenuating other treatment-related side effects, and improving survival. Exercise timing (e.g., exercising in the morning [AM] or afternoon/evening hours [PM]) may serve as a strategy to augment the effects of exercise among breast cancer patients receiving chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05821244.
PRIMARY OBJECTIVES:
I. Assess the feasibility of engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy.
Ia. Determine the acceptability engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy.
II. To generate evidence on the magnitude of the effect sizes and outcome variability of physical function and human performance variables.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in the POWER exercise program with workouts beginning between 5am and 10am, complete two supervised telehealth resistance training sessions over 45-60 minutes per week, and complete at least 90 minutes of moderate-intensity aerobic exercise per week over 4 weeks on study.
ARM II: Patients participate in the POWER exercise program with workouts beginning 3pm and 8pm, complete two supervised telehealth resistance training sessions over 45-60 minutes per week, and complete at least 90 minutes of moderate-intensity aerobic exercise per week over 4 weeks on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorAdriana Coletta
