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

June 15, 2026 updated by: Mayo Clinic

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
        • Contact:
        • Principal Investigator:
          • Diane K. Ehlers, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in inhibitory control
Time Frame: Baseline to post-intervention (month 6)
Change in interference score on Stroop task, with positive values indicating greater inhibitory control
Baseline to post-intervention (month 6)
Change in cognitive flexibility
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
Change in fractional anisotropy as measured by diffusion MRI.
Baseline to post-intervention (month 6)
Change in resting state functional connectivity
Time Frame: Baseline to post-intervention (month 6)
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
Time Frame: Baseline to post-intervention (month 6)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane K. Ehlers, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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