Cognitive Rehabilitation Following Breast Cancer Treatment

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT06545045
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Female

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Metacognitive Strategy Training (MCST) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Feasibility measures [ Time Frame: After study completion, an average of 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MissouriColumbiaMissouri65211
Anna E Boone
[email protected]
5738827023
Juliana H Earwood
[email protected]
5738846681

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By research site
University of Missouri· Columbia, MO

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