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NCT Number: 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

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.

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Key information

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

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Diane K. Ehlers, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerometry

Procedure

Ancillary studies

Aerobic Exercise

Other

Participate in walking program

Other names: Aerobic Activity

Electronic Health Record Review

Other

Ancillary studies

functional magnetic resonance imaging

Procedure

Undergo fMRI

Other names: fMRI, Functional MRI

Gait Assessment Test

Other

Ancillary studies

Health Education

Behavioral

Receive health education

interview

Other

Ancillary studies

Neurocognitive Assessment

Other

Ancillary studies

Physical Performance Testing

Other

Ancillary studies

Other names: Physical Fitness Testing, Physical Function Testing

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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

  7. 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

  8. 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

  9. 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

  10. Change in white matter integrity

    Time frame: Baseline to post-intervention (month 6)

    Change in fractional anisotropy as measured by diffusion MRI.

  11. 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

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Movement and Memory After Breast Cancer: The MAMA Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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