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
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Mayo Clinic
- Study ID
- NCT07331077
- Status
- Not Yet Recruiting
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Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Cancer-related Cognitive Dysfunction
Eligibility Criteria
- Sex
- FEMALE
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Accelerometry — PROCEDUREAncillary studies
- Aerobic Exercise — OTHERParticipate in walking program
- Electronic Health Record Review — OTHERAncillary studies
- Functional Magnetic Resonance Imaging — PROCEDUREUndergo fMRI
- Gait Assessment Test — OTHERAncillary studies
- Health Education — BEHAVIORALReceive health education
- Interview — OTHERAncillary studies
- Neurocognitive Assessment — OTHERAncillary studies
- Physical Performance Testing — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Aug 7, 2026
- Status verified
- Apr 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm A (walking program)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.
- Active Comparator: Arm B (health education)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.
Primary Outcome Measure
Change in inhibitory control [ Time Frame: Baseline to post-intervention (month 6) ]
Central Contacts
- Clinical Trials Referral Office855-776-0015
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Diane K. Ehlers, PhD (PRINCIPAL_INVESTIGATOR) |
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