Cognitive Rehabilitation Following Breast Cancer Treatment
- Conditions
- Breast Cancer Female
- Interventions
- Behavioral: Metacognitive Strategy Training (MCST)Behavioral: Inactive Control Group
- Registration Number
- NCT06545045
- Lead Sponsor
- University of Missouri-Columbia
- 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 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.
- 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., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metacognitive strategy training (MCST) Metacognitive Strategy Training (MCST) Each MCST session will be follow the procedures of Cognitive Orientation to daily Occupational Performance (CO-OP) intervention. There will be 10, 45-minute, weekly sessions. All sessions will be delivered in-person with a trained occupational therapist. Inactive Control Group Inactive Control Group Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.
- Primary Outcome Measures
Name Time Method Feasibility measures After study completion, an average of 12 weeks Recruitment rate, retention rate
Canadian Occupational Performance Measure (COPM) Performance Pre-intervention (week 0) and post-intervention (week 12) Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Canadian Occupational Performance Measure (COPM) Satisfaction Pre-intervention (week 0) and post-intervention (week 12) Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
- Secondary Outcome Measures
Name Time Method Paced Auditory Serial Addition Test (PASAT) Pre-intervention (week 0) and post-intervention (week 12) 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.
Trail Making Test (TMT) Pre-intervention (week 0) and post-intervention (week 12) 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.
Functional Assessment of Cancer Therapy-Breast (FACT-B) Pre-intervention (week 0) and post-intervention (week 12) A quality-of-life measure across five domains: Physical, social, emotional, functional well-being, and breast-cancer subscale.
Hopkins Verbal Learning Test-Revised (HVLT-R) Pre-intervention (week 0) and post-intervention (week 12) 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.
Cognitive Failures Questionnaire (CFQ) Pre-intervention (week 0) and post-intervention (week 12) 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.
Dysexecutive Questionnaire (DEX) Pre-intervention (week 0) and post-intervention (week 12) 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).
Controlled Oral Word Association (COWA) Pre-intervention (week 0) and post-intervention (week 12) Measure of verbal fluency that requires spontaneous word production for a different letter of the alphabet across three different trials.
The Activity Card Sort (ACS) Pre-intervention (week 0) and post-intervention (week 12) 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.
Participation Strategies Self Efficacy Scale (PS-SES) Pre-intervention (week 0) and post-intervention (week 12) 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.
Trial Locations
- Locations (1)
University of Missouri
🇺🇸Columbia, Missouri, United States