Clinical Trials

Inclusion Criteria: Pre-Registration

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

• Self-identifies as Hispanic (any race)

• First time, primary diagnosis of Stage I-IIIa breast cancer according to participant report and/or clinical determination.

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

• 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.

• Self-reported ability to complete assessments by themselves or with assistance.

Exclusion Criteria: Pre-Registration

• Stage 0 breast cancer diagnosis OR metastatic disease.

• Currently receiving or <3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment.

• Planned surgery during the intervention period.

• Secondary cancer diagnosis (excluding non-invasive skin cancers, carcinoma-in-situ for any cancer)

• Unable to regularly attend the study locations for intervention sessions and data collection.

• Unwilling to return to enrolling institution for follow-up.

• Self-reported inability to walk without assistance or devices.

Registration – Inclusion Criteria:

• Age ≥ 50 years or older as confirmed via clinical determination.

• Self-identifies as Hispanic (any race)

  Able to provide medical record release to confirm eligibility.

  First time, primary diagnosis of Stage I-IIIa breast cancer as confirmed via clinical determination.

• 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

• No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status [13-item modified version] (TICS-M; score >21)

• 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 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%

• Ability to complete assessments by themselves or with assistance.

• Agree to be randomized

Registration – Exclusion Criteria:

• History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination

• Clinically significant TICS-M score (<21) during baseline procedures

• 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)

• Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols.

• 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.

• Enrolled in another physical activity program.

• Unable to walk without assistance or devices.

• Unwilling to complete study requirements.

• Unwilling to be randomized to the exercise group or health education group.

• Unable to regularly attend study locations for intervention sessions and data collection.

• Unwilling to return to enrolling institution for follow-up.

• Unable to complete the study in English or Spanish.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/25/2025. Questions regarding updates should be directed to the study team contact.