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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination

• PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination

• PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to registration according to participant report and/or clinical determination

• PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months

• PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance

• REGISTRATION: Age ≥50 years as confirmed via clinical determination

• REGISTRATION: Able to provide medical record release to confirm eligibility

• REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination

• REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to pre-registration as confirmed via clinical determination

• REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score \> 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy

• REGISTRATION: Receive physician's clearance to participate in an exercise program

‣ NOTE: Individuals with conditions/diagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:

• History of major multiple myocardial infarctions (MI)

• Recent electrocardiogram (ECG) changes or recent MI

• Resting or unstable angina

• Significant multivessel coronary occlusion (≥ 70%) on angiography

• Uncontrolled and/or serious arrhythmias

• 3rd degree heart block

• Acute congestive heart failure or ejection fraction \< 30%

⁃ REGISTRATION: Ability to complete assessments by themselves or with assistance

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Phoenix
Contact Information
Primary
Melissa Cole, MS
cole.melissa@mayo.edu
480-574-4052
Backup
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 160
Treatments
Experimental: Arm I (Aerobic Exercise)
Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study.
Active_comparator: Arm II (Health Education)
Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.
Authors
Diane K Ehlers
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov