RECRUITING

Cognitive Rehabilitation Following Breast Cancer Treatment

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

Quick Facts

Study Start:2024-10-31

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06545045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Anna E. Boone, PhD, OTR/L

CONTACT

5738827023

booneae@umsystem.edu

Juliana H. Earwood, OTD, OTR/L

CONTACT

5738846681

jmhudson@health.missouri.edu

Principal Investigator

Anna E Boone, PhD, OTR/L

PRINCIPAL_INVESTIGATOR

University of Missouri Occupational Therapy

Study Locations (Sites)

University of Missouri

Columbia, Missouri, 65211

United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

Anna E Boone, PhD, OTR/L, PRINCIPAL_INVESTIGATOR, University of Missouri Occupational Therapy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Cancer
Breast Cancer
Cognition
Metacognition
Activities of daily living

Additional Relevant MeSH Terms

Breast Cancer Female