Cognitive Rehabilitation Following Breast Cancer Treatment

February 17, 2026 updated by: Anna Boone, University of Missouri-Columbia

Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Metacognitive Strategy Training (MCST)
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.
Active Comparator: Inactive Control Group
Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.
Behavioral: Inactive Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility measures
Time Frame: After study completion, an average of 12 weeks
Recruitment rate, retention rate
After study completion, an average of 12 weeks
Canadian Occupational Performance Measure (COPM) Performance
Time Frame: Pre-intervention (week 0) and post-intervention (week 12)
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
Time Frame: Pre-intervention (week 0) and post-intervention (week 12)
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

Outcome Measure
Measure Description
Time Frame
Cognitive Failures Questionnaire (CFQ)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
Dysexecutive Questionnaire (DEX)
Time Frame: 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).
Pre-intervention (week 0) and post-intervention (week 12)
Trail Making Test (TMT)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
Controlled Oral Word Association (COWA)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
The Activity Card Sort (ACS)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
Participation Strategies Self Efficacy Scale (PS-SES)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
Paced Auditory Serial Addition Test (PASAT)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time Frame: 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.
Pre-intervention (week 0) and post-intervention (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Anna E Boone, PhD, OTR/L, University of Missouri Occupational Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2101565
  • 1R21CA286404 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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