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

Official title

Movement and Memory After Breast Cancer: The MAMA Trial

Overview

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.

Interventions

• Procedure Accelerometry
  Ancillary studies
• Other Aerobic Exercise
  Participate in walking program
• Other Electronic Health Record Review
  Ancillary studies
• Procedure Functional Magnetic Resonance Imaging
  Undergo fMRI
• Other Gait Assessment Test
  Ancillary studies
• Behavioral Health Education
  Receive health education
• Other Interview
  Ancillary studies
• Other Neurocognitive Assessment
  Ancillary studies
• Other Physical Performance Testing
  Ancillary studies
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Change in inhibitory control [Time frame: Baseline to post-intervention (month 6)]
• Change in cognitive flexibility [Time frame: Baseline to post-intervention (month 6)]
• Change in executive function processing [Time frame: Baseline to post-intervention (month 6)]
• Change in short-term memory [Time frame: Baseline to post-intervention (month 6)]
• Change in verbal memory [Time frame: Baseline to post-intervention (month 6)]
• Change in working memory [Time frame: Baseline to post-intervention (month 6)]
• Change in processing speed [Time frame: Baseline to post-intervention (month 6)]
• Change in attention [Time frame: Baseline to post-intervention (month 6)]
• Change in brain volume [Time frame: Baseline to post-intervention (month 6)]
• Change in white matter integrity [Time frame: Baseline to post-intervention (month 6)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Mayo Clinic in Arizona — Scottsdale

Identifiers

NCT: NCT07331077 · 25-007121

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗