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

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ClinicalTrials.gov Identifier: NCT03678441
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 19, 2018
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE August 17, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • Completion rate of the BrainCheck battery [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% confidence interval (CI).
  • Completion rate of the pen and paper assessment [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% CI.
  • Average time to complete the BrainCheck battery [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% CI.
  • Average time to complete the pen and paper assessment [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% CI.
  • Difference in completion rate between the BrainCheck battery and paper and pen assessment [ Time Frame: Up to 1 year ]
    Will be calculated along with 95% CIs.
  • Difference in time to completion between the BrainCheck battery and the pen and paper assessment [ Time Frame: Up to 1 year ]
    Will be calculated along with 95% CIs.
  • Difference in score between the BrainCheck battery and the pen and paper assessments [ Time Frame: Up to 1 year ]
    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) [ Time Frame: Up to 1 year ]
    Will be calculated along with 95% CIs.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery
Official Title  ICMJE A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Liver and Intrahepatic Bile Duct Disorder
Intervention  ICMJE
  • Behavioral: BrainCheck Cognitive Assessment
    Receive BrainCheck cognitive assessment
    Other Name: BrainCheck
  • Procedure: Cognitive Assessment
    Receive pen and paper cognitive assessment
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Behavioral: BrainCheck Cognitive Assessment
    • Procedure: Cognitive Assessment
  • Active Comparator: 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.
    Interventions:
    • Behavioral: BrainCheck Cognitive Assessment
    • Procedure: Cognitive Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Timothy Newhook, MD 713-794-1001 tnewhook@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03678441
Other Study ID Numbers  ICMJE 2018-0093
NCI-2018-01895 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0093 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Timothy Newhook, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP