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

Primary Purpose

Liver and Intrahepatic Bile Duct Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainCheck Cognitive Assessment
Cognitive Assessment
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Liver and Intrahepatic Bile Duct Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (BrainCheck and paper and pen cognitive assessment)

Group II (pen and paper and BrainCheck cognitive assessment)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Completion rate of the BrainCheck battery
Will be calculated along with a 95% confidence interval (CI).
Completion rate of the pen and paper assessment
Will be calculated along with a 95% CI.
Average time to complete the BrainCheck battery
Will be calculated along with a 95% CI.
Average time to complete the pen and paper assessment
Will be calculated along with a 95% CI.
Difference in completion rate between the BrainCheck battery and paper and pen assessment
Will be calculated along with 95% CIs.
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
Will be calculated along with 95% CIs.
Difference in score between the BrainCheck battery and the pen and paper assessments
Will be calculated along with 95% CIs.
Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of the electronic battery compared to the validated St. Louis University Mental Status Examination (SLUMS)
Will be calculated along with 95% CIs.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
October 9, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03678441
Brief Title
Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery
Official Title
A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver and Intrahepatic Bile Duct Disorder

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (BrainCheck and paper and pen cognitive assessment)
Arm Type
Experimental
Arm 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.
Arm Title
Group II (pen and paper and BrainCheck cognitive assessment)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
BrainCheck Cognitive Assessment
Other Intervention Name(s)
BrainCheck
Intervention Description
Receive BrainCheck cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
Cognitive Assessment
Intervention Description
Receive pen and paper cognitive assessment
Primary Outcome Measure Information:
Title
Completion rate of the BrainCheck battery
Description
Will be calculated along with a 95% confidence interval (CI).
Time Frame
Up to 1 year
Title
Completion rate of the pen and paper assessment
Description
Will be calculated along with a 95% CI.
Time Frame
Up to 1 year
Title
Average time to complete the BrainCheck battery
Description
Will be calculated along with a 95% CI.
Time Frame
Up to 1 year
Title
Average time to complete the pen and paper assessment
Description
Will be calculated along with a 95% CI.
Time Frame
Up to 1 year
Title
Difference in completion rate between the BrainCheck battery and paper and pen assessment
Description
Will be calculated along with 95% CIs.
Time Frame
Up to 1 year
Title
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
Description
Will be calculated along with 95% CIs.
Time Frame
Up to 1 year
Title
Difference in score between the BrainCheck battery and the pen and paper assessments
Description
Will be calculated along with 95% CIs.
Time Frame
Up to 1 year
Title
Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of the electronic battery compared to the validated St. Louis University Mental Status Examination (SLUMS)
Description
Will be calculated along with 95% CIs.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Newhook, MD
Phone
713-794-1001
Email
tnewhook@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Newhook, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Newhook, MD
Phone
713-794-1001
First Name & Middle Initial & Last Name & Degree
Timothy Newhook, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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