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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Liver and Intrahepatic Bile Duct Disorder

Treatments: Procedure: Cognitive Assessment; Behavioral: BrainCheck Cognitive Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03678441

NCI-2018-01895 (Registry Identifier)

2018-0093 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group I (BrainCheck and paper and pen cognitive assessment)

Experimental group

Description:

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.

Treatment:

Behavioral: BrainCheck Cognitive Assessment

Procedure: Cognitive Assessment

Group II (pen and paper and BrainCheck cognitive assessment)

Active Comparator group

Description:

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.

Treatment:

Behavioral: BrainCheck Cognitive Assessment

Procedure: Cognitive Assessment