Cognitive Rehabilitation Following Breast Cancer Treatment
NCT Number: NCT06545045
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female
Interventions: BEHAVIORAL: Metacognitive Strategy Training (MCST)|BEHAVIORAL: Inactive Control Group
Sponsor: University of Missouri-Columbia
Collaborators: National Institutes of Health (NIH)|National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-12-30

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 cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.

Primary Outcome Measures: Feasibility measures, Recruitment rate, retention rate, After study completion, an average of 12 weeks|Canadian Occupational Performance Measure (COPM) Performance, Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance., Pre-intervention (week 0) and post-intervention (week 12)|Canadian Occupational Performance Measure (COPM) Satisfaction, Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance., Pre-intervention (week 0) and post-intervention (week 12)
Secondary Outcome Measures: Cognitive Failures Questionnaire (CFQ), Self-report measure of lapses in motor function memory and perception. This questionnaire contains 25 items and scores range from 0 to 100. Higher scores = greater perceived impairment., Pre-intervention (week 0) and post-intervention (week 12)|Dysexecutive Questionnaire (DEX), Self-report measure of the functional impact of executive dysfunction. It consists of 20 items within four domains: (1) emotional, (2) motivational, (3) behavioral, and (4) cognitive. Each item is rated for frequency using a 5-point Likert scale ranging from 0 (never) to 4 (very often)., Pre-intervention (week 0) and post-intervention (week 12)|Trail Making Test (TMT), Part A is an attention, visual search, and motor speed task that involves connecting a series of numbers in ascending order. Part B requires alternating between numbers and letters to assess set shifting and executive abilities., Pre-intervention (week 0) and post-intervention (week 12)|Controlled Oral Word Association (COWA), Measure of verbal fluency that requires spontaneous word production for a different letter of the alphabet across three different trials., Pre-intervention (week 0) and post-intervention (week 12)|The Activity Card Sort (ACS), Self-report measure of participation in various everyday life activities that are in the categories of low demand leisure, high demand leisure, instrumental activities of daily living, and social activity. Cards are sorted according to if the subject is performing each activity as much, less than, or more as compared to before experiencing cancer-related cognitive impairment., Pre-intervention (week 0) and post-intervention (week 12)|Functional Assessment of Cancer Therapy-Breast (FACT-B), A quality-of-life measure across five domains: Physical, social, emotional, functional well-being, and breast-cancer subscale., Pre-intervention (week 0) and post-intervention (week 12)|Participation Strategies Self Efficacy Scale (PS-SES), Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources., Pre-intervention (week 0) and post-intervention (week 12)|Paced Auditory Serial Addition Test (PASAT), Measure of working memory and attention in which a series of single digit numbers are presented audibly individuals. The most recent two digits are to be summed prior to the next digit presented. Two commonly used subversions use a 2 second or 3 second inter-stimulus interval., Pre-intervention (week 0) and post-intervention (week 12)|Hopkins Verbal Learning Test-Revised (HVLT-R), Measure of verbal learning and memory in which a list of 12 words is to be recalled. Three learning trials with free recall followed by a delayed recall at 20 minutes and a recognition trial., Pre-intervention (week 0) and post-intervention (week 12)