Cognitive Rehabilitation Following Breast Cancer Treatment

Trial Title: Cognitive Rehabilitation Following Breast Cancer Treatment

NCT ID: NCT06545045

Condition: Breast Cancer Female

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Cancer
Breast Cancer
Cognition
Metacognition
Activities of daily living

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: All outcomes assessors will be blinded to participant study group assignment.

Intervention:

Intervention type: Behavioral
Intervention name: Metacognitive Strategy Training (MCST)
Description: 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.
Arm group label: Metacognitive strategy training (MCST)

Intervention type: Behavioral
Intervention name: Inactive Control Group
Description: 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.
Arm group label: Inactive Control Group

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 20 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: October 31, 2024

Completion date: December 30, 2025

Lead sponsor:
Agency: University of Missouri-Columbia
Agency class: Other

Collaborator:
Agency: National Institutes of Health (NIH)
Agency class: NIH

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Missouri-Columbia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06545045