This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04816006.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in ArizonaStatus: Active
Contact: Diane K. Ehlers
Phone: 480-301-8000
PRIMARY OBJECTIVES:
I. Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in breast cancer survivors (BCS) aged 50 and older (N=160).
II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
EXPLORATORY OBJECTIVES:
I. Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.
II. Investigate the feasibility of urinary metabolites as biomarkers of overall diet patterns.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.
ARM II: Patients participate in up to 9 monthly classes/webinars. Patients also receive informational portable document format (pdfs), videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.
After completion of study intervention, patients are followed up with at 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMayo Clinic in Arizona
Principal InvestigatorDiane K. Ehlers