ACTIVE_NOT_RECRUITING

nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

Conditions

Chemo-brain Chemotherapy-Related Cognitive Impairment Chemotherapy Cognitive Impairment neuroplasticity-based computerized cognitive remediation nCCR

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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 investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

Official Title

Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study

Quick Facts

Study Start:2022-08-01

Study Completion:2029-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05283629

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:35 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* between 35 and 80 years of age * have been diagnosed with noninvasive or invasive breast cancer * have undergone treatment with systemic chemotherapy within the last 1- 8 years * endorse persistent CRCI subjective complaints * have no active unstable medical condition * fluent in and able to read English.	* any active neurologic or untreated/non-remitted psychiatric disease, (e.g. active major depression or another major psychiatric disorder as described in DSM-5) * clinically significant cognitive impairment identified on cognitive screening, diagnosis of mild cognitive impairment or dementia * history of significant head trauma followed by persistent neurologic deficits * history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria) * any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol * Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening * red-green color blindness * Use of certain CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months.

Inclusion Criteria

Exclusion Criteria

* between 35 and 80 years of age
* have been diagnosed with noninvasive or invasive breast cancer
* have undergone treatment with systemic chemotherapy within the last 1- 8 years
* endorse persistent CRCI subjective complaints
* have no active unstable medical condition
* fluent in and able to read English.

* any active neurologic or untreated/non-remitted psychiatric disease, (e.g. active major depression or another major psychiatric disorder as described in DSM-5)
* clinically significant cognitive impairment identified on cognitive screening, diagnosis of mild cognitive impairment or dementia
* history of significant head trauma followed by persistent neurologic deficits
* history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria)
* any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
* Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening
* red-green color blindness
* Use of certain CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months.

Contacts and Locations

Study Locations (Sites)

Center for Cognitive Medicine at Vanderbilt University

Nashville, Tennessee, 37212

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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 Date2022-08-01

Study Completion Date2029-03-01

Study Record Updates

Study Start Date2022-08-01

Study Completion Date2029-03-01

Terms related to this study

Keywords Provided by Researchers

Chemotherapy
Cognitive Impairment
neuroplasticity-based computerized cognitive remediation
nCCR

Additional Relevant MeSH Terms

Chemo-brain
Chemotherapy-Related Cognitive Impairment