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

Официальное название

Movement and Memory After Breast Cancer: The MAMA Trial

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic in Arizona — Scottsdale

Идентификаторы

NCT: NCT07331077 · 25-007121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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