Actively Recruiting

Phase Not Applicable
Age: 50Years +
FEMALE
NCT04816006

Breast Cancer, Reasoning, and Activity Intervention

Led by Mayo Clinic · Updated on 2025-08-01

160

Participants Needed

1

Research Sites

179 weeks

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

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.

CONDITIONS

Official Title

Breast Cancer, Reasoning, and Activity Intervention

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older at pre-registration and registration
  • First primary diagnosis of stage I-IIIa breast cancer
  • Completed surgery and primary treatment (surgery, chemotherapy, and/or radiation) 3 to 36 months before registration
  • Sedentary lifestyle with no more than 90 minutes per week of moderate aerobic exercise in the past 6 months
  • Able to complete study assessments independently or with assistance
  • Able to provide medical record release for eligibility confirmation
  • No evidence of cognitive impairment based on Telephone Interview of Cognitive Status (score > 21)
  • Physician clearance to participate in exercise program
  • If having certain heart conditions, cardiologist clearance required
Not Eligible

You will not qualify if you...

  • Diagnosis of stage 0 breast cancer 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 study intervention period
  • Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ)
  • Unable or unwilling to travel regularly to study locations for sessions and data collection
  • Unable or unwilling to return to enrolling institution for follow-up
  • Unable to walk without assistance or devices
  • History of stroke, transient ischemic attack, neurological disorders, or brain surgery involving tissue removal
  • Cognitive impairment indicated by baseline Telephone Interview of Cognitive Status (score < 21)
  • Unable to provide physician re-clearance if required after exercise test
  • Contraindications to MRI according to safety protocols
  • Abnormal MRI scan 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 an activity tracker continuously during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

C

Clinical Trials Referral Office

CONTACT

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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