Cognitive Rehabilitation Following Breast Cancer Treatment

ConditionBreast Cancer Female

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age20-75

SponsorUniversity of Missouri-Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Metacognitive strategy training (MCST)Experimental treatment 1 intervention

Group B: Inactive Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility measures

Recruitment rate, retention rate

Time frame

After study completion, an average of 12 weeks

Canadian Occupational Performance Measure (COPM) Performance

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

Time frame