Status:
RECRUITING
Breast Cancer, Reasoning, and Activity Intervention
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief 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, whic...
Detailed Description
PRIMARY OBJECTIVES: I. Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in breast cancer survivors (BCS) aged 50 and ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria:
- PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
- PRE-REGISTRATION: Currently receiving or \< 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment
- PRE-REGISTRATION: Planned surgery during the intervention period
- PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
- PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up
- PRE-REGISTRATION: Self-reported inability to walk without assistance or devices
- REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
- REGISTRATION: Clinically significant TICS-M score (\< 21) during baseline procedures
- 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)
- REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
- 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
- REGISTRATION: Enrolled in another physical activity program
- REGISTRATION: Unable to walk without assistance or devices
- REGISTRATION: Unwilling to complete study requirements
- REGISTRATION: Unwilling to be randomized to the exercise group or health education group
- REGISTRATION: Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
- REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- REGISTRATION: Unwilling to return to enrolling institution for follow-up
Exclusion
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04816006
Start Date
February 22 2024
End Date
July 31 2027
Last Update
August 1 2025
Active Locations (1)
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1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054