Recruiting

Cognitive Rehabilitation

Sponsor:

University of Missouri-Columbia

Code:

NCT06545045

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Metacognitive Strategy Training (MCST)

Inactive Control Group

Study Details

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.

Conditions

Breast Cancer Female

Study ID

NCT06545045

Start date

Oct 31, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Inactive Control Group

Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.

Interventions

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.

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.

Primary outcome measure

  • Feasibility measures [ Time Frame: 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) ]
  • Canadian Occupational Performance Measure (COPM) Satisfaction [ Time Frame: Pre-intervention (week 0) and post-intervention (week 12) ]

Central Contacts and Locations

Central contacts

Anna E. Boone, PhD, OTR/L

5738827023booneae@umsystem.edu

Juliana H. Earwood, OTD, OTR/L

5738846681jmhudson@health.missouri.edu

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Anna E Boone

5738827023booneae@umsystem.edu

Juliana H Earwood

5738846681jmhudson@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Cancer
  • Breast Cancer
  • Cognition
  • Metacognition
  • Activities of daily living

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-02-19.