A Physical Activity Program Compared to Health Education for Improving Memory and Attention in Hispanic Women With Newly-Diagnosed Stage I-IIIa Breast Cancer, MAMA Trial

Mayo Clinic

Status: Not yet enrolling

Conditions: Cancer-related Cognitive Dysfunction; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8

Treatments: Procedure: Accelerometry; Behavioral: Health Education; Other: Gait Assessment Test; Other: Electronic Health Record Review; Other: Neurocognitive Assessment; Other: Physical Performance Testing; Other: Aerobic Exercise; Procedure: Functional Magnetic Resonance Imaging; Other: Questionnaire Administration; Other: Interview

Study type: Interventional

Funder types: Other

Identifiers

NCT07331077

25-007121 (Other Identifier)

NCI-2025-08551 (Registry Identifier)

Details and patient eligibility

About

This clinical trial compares a physical activity program to a health education program for improving memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer. Compared to non-Hispanic White breast cancer survivors (BCS), Hispanic BCS report greater depressive symptoms, emotional distress, anxiety, fear of recurrence, pain, fatigue, and financial toxicity, in addition to more cancer-related psychosocial needs and lower quality of life and social well-being. Cancer-associated cognitive decline (CACD) is a related symptom that has gained increasing attention in clinical research. Based on disparities in other outcomes, it is likely that Hispanic BCS also experience greater CACD than non-Hispanic White BCS, but interventions targeting CACD in Hispanic BCS are non-existent and critically needed. The benefits of aerobic exercise among BCS are well documented and include improvement in health outcomes that are associated with cognitive function including fatigue, anxiety, depression, and sleep. A physical activity program that includes aerobic exercise may be more effective than simple health education for improving cognitive functions like memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer.

Enrollment: 10 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• PRE-REGISTRATION: Self-identifies as Hispanic (any race)

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

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

• PRE-REGISTRATION: Sedentary except for casual lifestyle recreation, 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 or older as confirmed via clinical determination

• REGISTRATION: Self-identifies as Hispanic (any race)

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

• REGISTRATION: First time, 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)

• 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

• REGISTRATION: Agree to be randomized

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: Secondary cancer diagnosis (excluding non-invasive skin cancers, carcinoma-in-situ for any cancer)
• PRE-REGISTRATION: Unable to regularly attend 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
• PRE-REGISTRATION: Self-reported pregnancy
• 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 magnetic resonance imaging (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 to regularly attend study locations for intervention sessions and data collection
• REGISTRATION: Unwilling to return to enrolling institution for follow-up
• REGISTRATION: Unable to complete the study in English or Spanish
• REGISTRATION: Self-reported pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Arm A (walking program)

Experimental group

Description:

Patients participate in walking sessions over 60-75 minutes per week in weeks 1-2, 70-90 minutes per week in weeks 3-4, 90-120 minutes per week in weeks 5-8, 120-135 minutes per week in weeks 9-12, 135-150 minutes per week in weeks 13-16, and 150+ minutes per week in weeks 17-24. Patients also undergo fMRI throughout the trial.

Treatment:

Other: Interview

Other: Questionnaire Administration

Procedure: Functional Magnetic Resonance Imaging

Other: Aerobic Exercise

Other: Physical Performance Testing

Other: Neurocognitive Assessment

Other: Electronic Health Record Review

Other: Gait Assessment Test

Procedure: Accelerometry

Arm B (health education)

Active Comparator group

Description:

Patients receive health education including monthly classes/webinars for up to 9 sessions and informational materials (PDFs, videos, podcasts, and/or subscription to Mayo Clinic Health Letter). Patients also undergo fMRI throughout the trial.

Treatment:

Other: Questionnaire Administration

Procedure: Functional Magnetic Resonance Imaging

Other: Physical Performance Testing

Other: Neurocognitive Assessment

Other: Electronic Health Record Review

Other: Gait Assessment Test

Behavioral: Health Education

Procedure: Accelerometry