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

Movement and Memory After Breast Cancer: The MAMA Trial

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.

Study Overview

• Status: Not yet recruiting
• 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
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Functional Magnetic Resonance Imaging; Other: Interview; Other: Electronic Health Record Review; Other: Neurocognitive Assessment; Other: Physical Performance Testing; Procedure: Accelerometry; Other: Aerobic Exercise; Other: Gait Assessment Test; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Diane K. Ehlers, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Functional Magnetic Resonance Imaging; Undergo fMRI; Other Names: fMRI; Functional MRI; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Neurocognitive Assessment; Ancillary studies; Other: Physical Performance Testing; Ancillary studies; Other Names: Physical Fitness Testing; Physical Function Testing; Procedure: Accelerometry; Ancillary studies; Other: Aerobic Exercise; Participate in walking program; Other Names: Aerobic Activity; Other: Gait Assessment Test; Ancillary studies
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Functional Magnetic Resonance Imaging; Undergo fMRI; Other Names: fMRI; Functional MRI; Other: Electronic Health Record Review; Ancillary studies; Other: Neurocognitive Assessment; Ancillary studies; Other: Physical Performance Testing; Ancillary studies; Other Names: Physical Fitness Testing; Physical Function Testing; Procedure: Accelerometry; Ancillary studies; Other: Gait Assessment Test; Ancillary studies; Behavioral: Health Education; Receive health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inhibitory control	Change in interference score on Stroop task, with positive values indicating greater inhibitory control	Baseline to post-intervention (month 6)
Change in cognitive flexibility	Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility	Baseline to post-intervention (month 6)
Change in executive function processing	Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility	Baseline to post-intervention (month 6)
Change in short-term memory	Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory	Baseline to post-intervention (month 6)
Change in verbal memory	Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory	Baseline to post-intervention (month 6)
Change in working memory	Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory	Baseline to post-intervention (month 6)
Change in processing speed	Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed	Baseline to post-intervention (month 6)
Change in attention	Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention	Baseline to post-intervention (month 6)
Change in brain volume	Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan	Baseline to post-intervention (month 6)
Change in white matter integrity	Change in fractional anisotropy as measured by diffusion MRI.	Baseline to post-intervention (month 6)
Change in resting state functional connectivity	Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence	Baseline to post-intervention (month 6)
Change in self-reported cognitive function - FACT-Cog	The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.	Baseline to post-intervention (month 6)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Diane K. Ehlers, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): August 7, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavioral Disciplines and Activities; Diagnostic Techniques, Respiratory System; Psychological Tests; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Neuropsychological Tests; Exercise; Interviews as Topic; Exercise Test; Mental Status and Dementia Tests; Accelerometry
• Other Study ID Numbers: 25-007121 (Mayo Clinic Institutional Review Board); NCI-2025-08551 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No