Actively Recruiting

Phase Not Applicable
Age: 50Years +
FEMALE
ID04816006

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

Led by Mayo Clinic · Updated on 2026-05-20

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether a community-based aerobic exercise program can improve memory, attention, and brain health in women aged 50 and older who have survived breast cancer. This trial focuses on breast cancer survivors who often experience cognitive difficulties after treatment, which can affect their daily life and long-term wellness. The study also aims to understand how well this exercise program can be scaled for wider use. Participants are randomly assigned to one of two groups. The first group attends a structured 24-week exercise program led by personal trainers, starting with three weekly sessions and gradually decreasing to monthly sessions, totaling 20 supervised sessions. The second group receives health education through up to nine monthly classes, webinars, and access to informational materials such as newsletters, videos, and a health letter subscription. Both groups undergo gait assessments, MRI scans, and wear accelerometers to track activity throughout the study. During the study, participants complete cognitive tests measuring memory, attention, processing speed, and brain function at the start, after 6 months, and at a 12-month follow-up. Brain imaging assesses changes in brain volume and connectivity. Researchers also monitor physical fitness and cancer-related fatigue. Participants are followed for 6 months after the intervention to assess lasting effects and safety. The total study participation spans about one year.

CONDITIONS

Brief Title

Breast Cancer, Reasoning, and Activity Intervention

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 50 years or older at pre-registration and registration
  • First, primary diagnosis of stage I to IIIa breast cancer
  • Completed surgery, chemotherapy, and/or radiation therapy 3 to 36 months prior to registration
  • Sedentary lifestyle with no more than 90 minutes per week of moderate aerobic exercise in the last 6 months
  • Ability to complete study assessments independently or with assistance
  • Able to provide medical record release to confirm eligibility
  • No evidence of cognitive impairment as assessed by Telephone Interview of Cognitive Status (score > 21)
  • Physician clearance to participate in an exercise program
  • Clearance from cardiologist if history of significant heart conditions
Not Eligible

You will not qualify if you...

  • Stage 0 breast cancer diagnosis or metastatic disease
  • Currently receiving or less than 3 months since chemotherapy or radiation therapy, or more than 36 months post primary treatment
  • Planned surgery during the intervention period
  • Second cancer diagnosis (excluding certain non-invasive skin cancers)
  • Unable or unwilling to travel regularly to study locations
  • Unable or unwilling to return for follow-up visits
  • Unable to walk without assistance or devices
  • History of stroke, neurological disorders, or brain surgery involving tissue removal
  • Clinically significant cognitive impairment (score < 21)
  • Contraindications to MRI
  • Enrolled in another physical activity program
  • Unwilling to complete study requirements or be randomized
  • Unable or unwilling to wear and maintain an activity tracker continuously during the study period
  • Significant abnormal MRI findings requiring medical follow-up or intervention
  • Unable or unwilling to participate in the exercise or health education interventions as required

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 24 weeks

Participants engage in either a 6-month aerobic exercise program with supervised sessions or participate in monthly health education classes and receive wellness materials. Both groups undergo gait assessments, MRI scans, and wear an accelerometer throughout the study.

Up to 20 supervised exercise sessions or up to 9 monthly classes/webinars

Follow-up

Duration - 6 months

Participants are followed up 6 months after completing the intervention to assess long-term effects.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Arizona

Phoenix, Arizona, United States, 85054

Actively Recruiting

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Research Team

M

Melissa Cole, MS

C

Clinical Trials Referral Office

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.

Diane K Ehlers, Jessica D Austin, Brenda Ernst...

https://pubmed.ncbi.nlm.nih.gov/40659404