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Completed

NCT Number: NCT05505045

Metacognitive Strategy Training in Cancer-related Cognitive Impairment

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri Occupational Therapy Department

Columbia, Missouri, 65203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CO-OP Procedures

Behavioral

CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the 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.

Attention Control Procedures

Behavioral

Individuals in the attention control group will have dose-equivalent, weekly virtual contact through the Zoom platform for 12-weeks with a a trained interventionist not involved in CO-OP treatment. The control group will control for interpersonal interaction, maturation effects, and testing effects. The focus of each session will include: (1) social interaction characterized by warmth/empathy and (2) provision of usual care CRCI educational resources (e.g. exercise, using memory aids, minimizing distractions) from MD Anderson Cancer Center. These recommendations will be provided without further instruction. Any questions that arise regarding CRCI the subject is experiencing will be answered. The therapist will debrief with the subject on any changes in CRCI symptoms. The content and duration of each call will be tracked. Each session will be recorded with two randomly selected and reviewed for fidelity.

Primary outcomes

  1. Telehealth Usability Questionnaire (TUQ)

    Time frame: 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).

  2. Acceptability of Intervention Measure (AIM)

    Time frame: After study completion, an average of 14 weeks

    Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

  3. Intervention Appropriateness Measure (IAM)

    Time frame: After study completion, an average of 14 weeks

    Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

  4. Feasibility of Intervention Measure (FIM)

    Time frame: After study completion, an average of 14 weeks

    Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

  5. Canadian Occupational Performance Measure (COPM) Trained Goal Performance

    Time frame: Pre-intervention (week 0) and post-intervention (week 14)

    Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  6. NeuroQoL Cognitive Function Short Form

    Time frame: 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.

  7. Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction

    Time frame: 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.

Secondary outcomes

  1. Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Time frame: 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.

  2. Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest

    Time frame: 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.

  3. Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest

    Time frame: 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.

  4. Brief Visuospatial Memory Test -Revised Trial 1

    Time frame: 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.

  5. Paced Auditory Serial Addition Test

    Time frame: 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.

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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