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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
The MCST group will follow procedures for the Cognitive Orientation to daily Occupational Performance intervention. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, the therapist introduces the approach to the subject and teach a global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition. The subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.
Weekly contact will be made via telephone call to (1) maintain study engagement, (2) introduce weekly social contact with researchers, mimicking some of the potential incidental effects of the experimental group, and (3) ascertain what, if any, additional steps participants have taken to reduce cognitive symptoms. The content of each of these meetings will be tracked in intervention notes.
University of Missouri
Columbia, Missouri, United States
RECRUITINGFeasibility measures
Recruitment rate, retention rate
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
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.
Time frame: 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).
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)