Metacognitive Strategy Training in Cancer-related Cognitive Impairment

Not Applicable

Completed

Conditions: Breast Cancer Female

Interventions: Behavioral: CO-OP Procedures
Behavioral: Attention Control Procedures

Registration Number: NCT05505045

Lead Sponsor: University of Missouri-Columbia

Brief Summary: The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.

Detailed Description: Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. cancer-related cognitive impairment (CRCI)). These cognitive changes have a devastating impact on everyday life activities, such as work/productivity, community involvement, driving, and financial management. While CRCI would likely be amenable to rehabilitation services, breast cancer survivors face two primary barriers to adequate rehabilitation, including (1) inadequate access to rehabilitation services, and (2) limited effective interventions to address CRCI.

Breast cancer survivors have inadequate access to rehabilitation services to address CRCI. A recent report sponsored by the National Cancer Institute (NCI) concluded that most NCI-designated cancer centers do not have integrated cancer rehabilitation services. Even if comprehensive rehabilitation services were provided by these centers, millions of cancer survivors live in rural areas outside close proximity to a cancer center and are more likely to experience poorer outcomes compared to urban counterparts. If rehabilitation services were provided, proximity to facilities may be a limiting factor in individuals from rural communities receiving rehabilitative care. Access to services has been further curtailed amid the COVID-19 pandemic, with calls building from national organizations for improvements in remote delivery of services.

Metacognitive strategy training (MCST) is a practice standard to address cognitive impairment in other conditions, such as traumatic brain injury and stroke. 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. The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. While current evidence supports the remote delivery of strategy-based interventions like CO-OP, this intervention has not been evaluated in breast cancer survivors with CRCI.

The investigators' overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognition, and subjective quality of life in breast cancer survivors with CRCI.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 46

Inclusion Criteria

self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score >30)
completed full course of chemotherapy at least 6 months, but no later 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
diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and completed chemotherapy within the preceding three years
on stable doses of medications (i.e., no changes in past 60 days)

Exclusion Criteria

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 function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury)
severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP)	CO-OP Procedures	Each CO-OP session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
Attention Control Group	Attention Control Procedures	Each session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Primary Outcome Measures

Name	Time	Method
Telehealth Usability Questionnaire (TUQ)	After study completion, an average of 14 weeks	Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree).
Acceptability of Intervention Measure (AIM)	After study completion, an average of 14 weeks	Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Feasibility of Intervention Measure (FIM)	After study completion, an average of 14 weeks	Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Intervention Appropriateness Measure (IAM)	After study completion, an average of 14 weeks	Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction	After study completion, an average of 14 weeks	Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Canadian Occupational Performance Measure (COPM) Trained Goal Performance	Pre-intervention (week 0) and post-intervention (week 14)	Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
NeuroQoL Cognitive Function Short Form	Pre-intervention (week 0) and post-intervention (week 14)	Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-Breast (FACT-B)	Pre-intervention (week 0) and post-intervention (week 14)	Self-report measure of quality of life for breast cancer survivors. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). The range of scores is 0 to 148. Higher scores indicate decreased perceived well-being and quality of life.
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest	Pre-intervention (week 0) and post-intervention (week 14)	Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of Number/Letter switching. Age-adjusted scale scores with a mean of 10 and standard deviation of 3 are reported. The total range of scores is 1-19. Higher scores indicate better performance.
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest	Pre-intervention (week 0) and post-intervention (week 14)	Objective measure of cognitive performance. The Letter-Number subtest measures working memory. The Coding and Symbol Search subtest measure processing speed. Higher scores indicate better cognitive performance. Age adjusted scaled scores with a mean of 10 and standard deviation of 3 are reported. Range of reported scores is 1 to 19.
Brief Visuospatial Memory Test -Revised Trial 1	Pre-intervention (week 0) and post-intervention (week 14)	Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory. T-scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better performance.
Paced Auditory Serial Addition Test	Pre-intervention (week 0) and post-intervention (week 14)	Objective measure of working memory. Participant is presented with single digits every 2 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory.
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities	Pre-intervention (week 0) and post-intervention (week 14)	Self-report measure of ability to participate in social roles and activities. Higher scores reflect higher abilities. T-scores are reported with a mean of 50 and a standard deviation of 10.