Improving Brain Function Through Community Exercise in Women Over 50 Who Survived Breast Cancer
Led by Mayo Clinic · Updated on 2026-07-31
160
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a community-based aerobic exercise intervention to improve cognitive function in breast cancer survivors aged 50 and older. The study focuses on memory, attention, and brain health, addressing cognitive challenges that impact daily life and quality of life after breast cancer treatment. This phase II trial also assesses the potential for scaling the exercise program and explores urinary metabolites as diet biomarkers.
Participants are randomly assigned to one of two groups. The exercise group attends supervised sessions that gradually change in frequency and duration over 24 weeks, including treadmill walking and other cardiovascular equipment, with a total of 20 sessions. The comparison group participates in monthly health education classes, receives informational materials, and a one-year subscription to a health newsletter. Both groups undergo gait assessments, MRI scans, and wear accelerometers throughout the study.
During the study, participants complete cognitive tests at baseline, after 6 months of intervention, and at a 12-month follow-up. Researchers measure changes in brain volume, white matter integrity, functional connectivity, and self-reported cognitive function. Fitness and cancer-related fatigue are also tracked. The study includes safety monitoring through physician clearance and provides follow-up assessments six months after completing the intervention, with total participation lasting up to one year.
CONDITIONS
Brief Title
Breast Cancer, Reasoning, and Activity Intervention
Research Team
M
Melissa Cole, MS
C
Clinical Trials Referral Office
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Aerobic exercise training
Health education sessions
Guideline-recommended exercise
What the intervention or comparator is
A structured 24-week moderate-intensity aerobic exercise program progressively delivered and tailored by fitness trainers
Health education sessions and monthly newsletters/webinars over 24 weeks
Professional consensus recommends exercise training as safe and beneficial supportive care for cancer survivors
Role in the trial
Investigational behavioral intervention arm
Active comparator arm receiving education sessions
Represents usual supportive exercise care outside the trial context
Primary purpose or use
To improve cognitive function and fitness in breast cancer survivors
To provide supportive education on wellness and coping strategies
Support overall health, function and resilience in cancer survivorship
How it is given or performed
Supervised sessions tapering from three weekly to monthly over 24 weeks, tailored to participant fitness
Education sessions plus newsletters/webinars delivered monthly across 24 weeks
Typically delivered through community or clinical rehabilitation programs per consensus recommendations
Evidence beyond this trial
Exercise improves self‑reported cognitive function in breast cancer survivors according to meta‑analysis and RCTs
Limited evidence that educational support alone improves cognitive outcomes
Exercise is broadly supported to improve quality‑of‑life and function in cancer survivors
Important known risks
Risks such as cardiovascular events possible if not screened, but supervised training is generally safe
Minimally risky educational program
Exercise is safe when tailored and cleared appropriately
Important limitations
Supervised exercise may not be scalable or accessible to all survivors
May lack sufficient behavioral stimulus to drive cognitive improvement
General guidelines may not translate to individualized cognitive outcomes
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 50Years +
FEMALE
Eligibility Criteria
You may qualify if you...
Age 50 years or older at time of pre-registration
First, primary diagnosis of stage I to IIIa breast cancer
Completed primary treatment (surgery, chemotherapy, and/or radiation) 3 to 60 months prior to registration
Sedentary lifestyle with no more than 90 minutes per week of moderate-intensity aerobic exercise in the last 6 months
Ability to complete assessments independently or with assistance
Able to provide medical record release to confirm eligibility
No evidence of cognitive impairment based on Telephone Interview of Cognitive Status (score > 21)
Physician clearance to participate in an exercise program
Ability to complete assessments by themselves or with assistance
You will not qualify if you...
Stage 0 breast cancer or metastatic disease
Receiving or less than 3 months since chemotherapy or radiation, or more than 60 months post primary treatment
Planned surgery during the intervention period
Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ)
Unable to travel regularly to study locations or unwilling to return for follow-up
Unable to walk without assistance or devices
History of stroke, neurological disorders, or brain surgery involving tissue removal
Unable to provide physician re-clearance for exercise if required
Contraindications to MRI
Clinically significant abnormal MRI requiring medical follow-up
Enrolled in another physical activity program
Unwilling to complete study requirements or be randomized
Unable or unwilling to wear and maintain activity tracker
Unwilling to travel or return for follow-up
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Intervention
Duration - 6 months
Participants receive either supervised aerobic exercise sessions with gradually increasing frequency and duration or participate in monthly health education classes with wellness materials. Both groups undergo cognitive testing, MRI scans, gait assessments, and wear accelerometers throughout the 6-month intervention.
Up to 20 exercise sessions or 9 education sessions, plus assessment visits
Follow-up
Duration - 6 months
After the intervention, participants are followed up at 6 months to assess lasting effects on cognitive function and brain health.
1 follow-up visit
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design.