RECRUITING

Breast Cancer, Reasoning, and Activity Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-22
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04816006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * PRE-REGISTRATION: Individual who was pre- or peri-menopausal at the time of diagnosis with breast cancer
  2. * PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
  3. * PRE-REGISTRATION: Currently receiving or \< 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 24 months post primary treatment
  4. * PRE-REGISTRATION: Planned surgery during the intervention period
  5. * PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
  6. * PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
  7. * PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up
  8. * PRE-REGISTRATION: Self-reported inability to walk without assistance or devices
  9. * REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
  10. * REGISTRATION: Clinically significant TICS-M score (\< 21) during baseline procedures
  11. * REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)
  12. * REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
  13. * REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up
  14. * REGISTRATION: Enrolled in another physical activity program
  15. * REGISTRATION: Unable to walk without assistance or devices
  16. * REGISTRATION: Unwilling to complete study requirements
  17. * REGISTRATION: Unwilling to be randomized to the exercise group or health education group
  18. * REGISTRATION: Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
  19. * REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
  20. * REGISTRATION: Unwilling to return to enrolling institution for follow-up

Contacts and Locations

Study Contact

Gabriella Hickman, MS
CONTACT
480-574-1369
Hickman.Gabriella@mayo.edu
Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Diane K. Ehlers, Ph.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Diane K. Ehlers, Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-22
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-02-22
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • physical activity
  • exercise
  • cognition
  • brain health
  • breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Neoplasms
  • Anatomic Stage I Breast Cancer AJCC V8
  • Anatomic Stage II Breast Cancer AJCC V8
  • Anatomic Stage IIIA Breast Cancer AJCC V8
  • Cancer-related Cognitive Dysfunction