RecruitingNot ApplicableNCT04816006

Breast Cancer, Reasoning, and Activity Intervention

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

Sponsor

Mayo Clinic

Enrollment

160 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Cancer-related Cognitive Dysfunction

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.

Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a physical activity and reasoning-based program can improve thinking and memory in breast cancer survivors who are not very active. Many breast cancer patients notice mental "fog" after treatment. The researchers want to see if adding exercise to a thinking-skills program helps clear that fog. **You may be eligible if...** - You are 50 years or older - You have had a first-time diagnosis of early-stage breast cancer (stage I–IIIa) - You have finished surgery, chemotherapy, and/or radiation at least 3 months ago, but no more than 36 months ago - You are mostly inactive (less than 90 minutes of moderate exercise per week in the last 6 months) - You are able to complete assessments on your own or with some help **You may NOT be eligible if...** - You are still in active primary treatment (surgery, chemo, or radiation) - You already exercise regularly - You have had a prior breast cancer diagnosis - You have significant physical limitations that prevent exercise Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAerobic 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).

OTHERHealth 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.