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

NCT07331077 | Not Yet Recruiting

• 1 other identifier: 25-007121
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (12)

• 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)

Study Arms (2)

Arm A (walking program)

EXPERIMENTAL

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.

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 COMPARATOR

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.

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

Interventions

Accelerometry PROCEDURE

Ancillary studies

Arm A (walking program); Arm B (health education)

Aerobic Exercise OTHER

Participate in walking program

Also known as: Aerobic Activity

Arm A (walking program)

Electronic Health Record Review OTHER

Ancillary studies

Arm A (walking program); Arm B (health education)

Interview OTHER

Ancillary studies

Arm A (walking program)

Neurocognitive Assessment OTHER

Ancillary studies

Arm A (walking program); Arm B (health education)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Arm A (walking program); Arm B (health education)

Questionnaire Administration OTHER

Ancillary studies

Arm A (walking program); Arm B (health education)

Functional Magnetic Resonance Imaging PROCEDURE

Undergo fMRI

Also known as: fMRI, Functional MRI

Arm A (walking program); Arm B (health education)

Gait Assessment Test OTHER

Ancillary studies

Arm A (walking program); Arm B (health education)

Health Education BEHAVIORAL

Receive health education

Arm B (health education)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Accelerometry; Exercise; Interviews as Topic; Mental Status and Dementia Tests; Exercise Test

Intervention Hierarchy (Ancestors)

Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Study Officials

• Diane K. Ehlers, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 9, 2026
• Study Start (Estimated): August 7, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)