NCT06545045 Cognitive Rehabilitation Following Breast Cancer Treatment
| NCT ID | NCT06545045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-10-31 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Anna E Boone, PhD, OTR/L
PRINCIPAL INVESTIGATOR
University of Missouri Occupational Therapy
Frequently Asked Questions
Who can join the NCT06545045 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 75 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545045 currently recruiting?
Yes, NCT06545045 is actively recruiting participants. Contact the research team at booneae@umsystem.edu for enrollment information.
Where is the NCT06545045 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT06545045 clinical trial?
NCT06545045 is sponsored by University of Missouri-Columbia. The principal investigator is Anna E Boone, PhD, OTR/L at University of Missouri Occupational Therapy. The trial plans to enroll 50 participants.
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