Status:
RECRUITING
Cognitive Rehabilitation Following Breast Cancer Treatment
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
20-75 years
Phase:
NA
Brief Summary
The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast can...
Detailed Description
Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., c...
Eligibility Criteria
Inclusion
- self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score \>30)
- completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation
- able to read, write, and speak English fluently
- able to provide valid informed consent
- have a life expectancy of greater than 6 months at time of enrollment
- on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)
Exclusion
- prior cancer diagnoses of other sites with evidence of active disease within the past year
- active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \<23 on the Montreal Cognitive Assessment (MoCA)
- severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)
- history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)
- conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)
- blue-yellow colorblindness
- pregnancy
- The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06545045
Start Date
October 31 2024
End Date
December 30 2025
Last Update
December 6 2024
Active Locations (1)
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1
University of Missouri
Columbia, Missouri, United States, 65211