Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery

NCT ID: NCT03678441

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-17

Study Completion Date

2027-04-30

Brief Summary

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This trial studies how well electronic neurocognitive tools work in screening for mental capability in patients who are undergoing liver surgery. Using electronic neurocognitive screening tools may help to better assess mental impairment.

Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.

SECONDARY OBJECTIVES:

I. Comparison of the completion rate and time to completion between the written and electronic batteries.

II. Comparison of the scoring distribution between the screening tools.

EXPLORATORY OBJECTIVES:

I. Assess if a history of mental or cognitive illness or ongoing treatment with neuropsychiatric medications impact the ability to complete written and/or electronic neurocognitive screening.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen cognitive assessment within 2 months prior to surgery and within 2 months after surgery.

GROUP II: Patients receive the paper and pen cognitive assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.

Conditions

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Liver and Intrahepatic Bile Duct Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Group I (BrainCheck and paper and pen cognitive assessment)

Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen assessment 2 months prior to surgery and within 2 months after surgery.

Group Type EXPERIMENTAL

BrainCheck Cognitive Assessment

Intervention Type BEHAVIORAL

Receive BrainCheck cognitive assessment

Cognitive Assessment

Intervention Type PROCEDURE

Receive pen and paper cognitive assessment

Group II (pen and paper and BrainCheck cognitive assessment)

Patients receive the paper and pen assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.

Group Type ACTIVE_COMPARATOR

BrainCheck Cognitive Assessment

Intervention Type BEHAVIORAL

Receive BrainCheck cognitive assessment

Cognitive Assessment

Intervention Type PROCEDURE

Receive pen and paper cognitive assessment

Interventions

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BrainCheck Cognitive Assessment

Receive BrainCheck cognitive assessment

Intervention Type BEHAVIORAL

Cognitive Assessment

Receive pen and paper cognitive assessment

Intervention Type PROCEDURE

Other Intervention Names

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BrainCheck

Eligibility Criteria

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Inclusion Criteria

* All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Newhook, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2018-01895

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0093

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0093

Identifier Type: -

Identifier Source: org_study_id