Breast Cancer, Reasoning, and Activity Intervention

Launched by MAYO CLINIC · Mar 22, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how exercise can help improve thinking and memory skills in women who have survived breast cancer. Many survivors notice difficulties with their thinking abilities, which can affect their daily lives and overall well-being. The trial will compare the effects of an exercise program with health education on women’s cognitive function, which includes memory and attention. If successful, the findings could lead to better support programs for breast cancer survivors.

To be eligible for this trial, participants must be women aged 18 or older who have been diagnosed with early-stage breast cancer (Stages I-IIIa) and are post-menopausal. They should have completed their primary cancer treatments, including surgery, chemotherapy, and/or radiation, within the last 3 to 24 months and should not have been exercising regularly. Participants will be randomly assigned to either the exercise group or the health education group, and they can expect to engage in activities designed to help improve their brain health. It’s important that potential participants can travel to the study locations for sessions and follow-up visits.

Gender

FEMALE

Eligibility criteria

• • 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