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Anatomic Stage I Breast Cancer AJCC v8NCT07331077

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

A study testing Accelerometry, Aerobic Exercise and Electronic Health Record Review in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 years and older, women only
What is being tested?
Accelerometry, Aerobic Exercise and Electronic Health Record Review
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Diane K. Ehlers, PhD

Other trials in United States

About this study

Official title: 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.

Being tested
Accelerometry, Aerobic Exercise, Electronic Health Record Review, Functional Magnetic Resonance Imaging, Gait Assessment Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AccelerometryProcedure or surgery

    Ancillary studies

  • Aerobic ExerciseOther

    Also called Aerobic Activity

    Participate in walking program

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Functional Magnetic Resonance ImagingProcedure or surgery

    Also called fMRI, Functional MRI

    Undergo fMRI

  • Gait Assessment TestOther

    Ancillary studies

  • Health EducationBehavioural

    Receive health education

  • InterviewOther

    Ancillary studies

  • Neurocognitive AssessmentOther

    Ancillary studies

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07331077
Study groupRoleWhat they receive
Arm A (walking program)ExperimentalPatients 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.
Receives: Procedure: Accelerometry; Other: Aerobic Exercise; Other: Electronic Health Record Review; Procedure: Functional Magnetic Resonance Imaging; Other: Gait Assessment Test; Other: Interview; Other: Neurocognitive Assessment; Other: Physical Performance Testing; Other: Questionnaire Administration
Arm B (health education)Active comparatorPatients 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.
Receives: Procedure: Accelerometry; Other: Electronic Health Record Review; Procedure: Functional Magnetic Resonance Imaging; Other: Gait Assessment Test; Behavioral: Health Education; Other: Neurocognitive Assessment; Other: Physical Performance Testing; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in inhibitory control

    Change in interference score on Stroop task, with positive values indicating greater inhibitory control

    Measured: Baseline to post-intervention (month 6)

  2. Change in cognitive flexibility

    Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility

    Measured: Baseline to post-intervention (month 6)

  3. Change in executive function processing

    Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility

    Measured: Baseline to post-intervention (month 6)

  4. Change in short-term memory

    Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory

    Measured: Baseline to post-intervention (month 6)

  5. Change in verbal memory

    Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory

    Measured: Baseline to post-intervention (month 6)

  6. Change in working memory

    Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory

    Measured: Baseline to post-intervention (month 6)

  7. Change in processing speed

    Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed

    Measured: Baseline to post-intervention (month 6)

  8. Change in attention

    Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention

    Measured: Baseline to post-intervention (month 6)

  9. Change in brain volume

    Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan

    Measured: Baseline to post-intervention (month 6)

  10. Change in white matter integrity

    Change in fractional anisotropy as measured by diffusion MRI.

    Measured: Baseline to post-intervention (month 6)

  11. 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

    Measured: Baseline to post-intervention (month 6)

  12. 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.

    Measured: Baseline to post-intervention (month 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07331077
Sponsor's protocol ID
25-007121
Status last verified
Jun 2026
First submitted
9 Dec 2025
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Accelerometry, Aerobic Exercise and Electronic Health Record Review in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in inhibitory control (time frame: Baseline to post-intervention (month 6)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07331077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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