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

Summary

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.

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

Interventions

PROCEDURE

Accelerometry

Ancillary studies

OTHER

Aerobic Exercise

Participate in walking program

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Functional Magnetic Resonance Imaging

Undergo fMRI

OTHER

Gait Assessment Test

Ancillary studies

BEHAVIORAL

Health Education

Receive health education

OTHER

Interview

Ancillary studies

OTHER

Neurocognitive Assessment

Ancillary studies

OTHER

Physical Performance Testing

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Diane K. Ehlers, PhD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-07

Primary Completion

2027-11-30

Completion

2027-11-30

Countries

• United States

Study Locations