Trials / Recruiting

RecruitingNCT04816006

Breast Cancer, Reasoning, and Activity Intervention

Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 160 (estimated)

Sponsor: Mayo Clinic · Academic / Other
Sex: Female
Age: 50 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Aerobic Exercise Training	Breast cancer survivors in the intervention group will participate in a 24-week moderate intensity exercise program led by community-based fitness center personal trainers. Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Treadmill walking is the primary mode of exercise. However, participants will be permitted to use other cardiovascular equipment (e.g., elliptical machines, stationary bicycles) as prescribed by their exercise trainer. The trainer will supervise three weekly exercise sessions in Weeks 1-2, two in Weeks 3-4, one in Weeks 5-8, biweekly across weeks 9-16, and monthly in Weeks 17-24 (N=20 supervised sessions).
OTHER	Health Education (Active comparator)	Breast cancer survivors in the Health Education group will participate in education sessions with a health educator and receive monthly newsletters/webinars (N=20 total contacts) across 24 weeks. The program will include cancer support and discussion of cancer-related wellness topics (e.g., stress management, coping). Control group participants will be offered a 6-month fitness center membership upon study completion.

Timeline

Start date: 2024-02-22
Primary completion: 2027-07-31
Completion: 2027-07-31
First posted: 2021-03-25
Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04816006. Inclusion in this directory is not an endorsement.