Physical Activity for Memory and Attention in Hispanic Women with Breast Cancer

This study, called the MAMA Trial, is looking at whether a physical activity program can improve memory and attention in Hispanic women who are 50 years or older and have been recently diagnosed with stage I-IIIa breast cancer. It compares this physical activity program to a health education program. Researchers want to see if these programs can help with issues like memory and attention, which can sometimes be affected by cancer and its treatments. The study aims to enroll 10 participants and will measure changes in inhibitory control, cognitive flexibility, and executive function processing over six months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 10 women. It compares a physical activity program to a health education program.
What's involved
Participants will engage in a walking program and may undergo procedures like accelerometry, fMRI, and gait assessment. Electronic health record reviews will also be conducted.
Compensation
Not stated in the trial record.
Follow-up
Changes in memory and attention will be measured from the start of the study to six months after the intervention.

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NCT07331077

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

Not Yet Recruiting
NAAges 50+InterventionalSupportive care
Mayo Clinic
~10 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:AccelerometryAerobic ExerciseElectronic Health Record ReviewFunctional Magnetic Resonance ImagingGait Assessment TestHealth Education

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in inhibitory control
Measured over Baseline to post-intervention (month 6)
+11 more outcomes measured
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
1 sites across 1 states
Arizona1
  • Diane K. Ehlers, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Change in inhibitory controlBaseline to post-intervention (month 6)

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

  • Change in cognitive flexibilityBaseline to post-intervention (month 6)

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

  • Change in executive function processingBaseline to post-intervention (month 6)

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

  • Change in short-term memoryBaseline to post-intervention (month 6)

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

  • Change in verbal memoryBaseline to post-intervention (month 6)

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

  • Change in working memoryBaseline to post-intervention (month 6)

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

  • Change in processing speedBaseline to post-intervention (month 6)

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

  • Change in attentionBaseline to post-intervention (month 6)

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

  • Change in brain volumeBaseline to post-intervention (month 6)

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

  • Change in white matter integrityBaseline to post-intervention (month 6)

    Change in fractional anisotropy as measured by diffusion MRI.

  • Change in resting state functional connectivityBaseline 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

  • Change in self-reported cognitive function - FACT-CogBaseline 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.