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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 : June 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Liver and Intrahepatic Bile Duct Disorder Behavioral: BrainCheck Cognitive Assessment Procedure: Cognitive Assessment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
Actual Study Start Date : August 17, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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.
Behavioral: BrainCheck Cognitive Assessment
Receive BrainCheck cognitive assessment
Other Name: BrainCheck

Procedure: Cognitive Assessment
Receive pen and paper 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.
Behavioral: BrainCheck Cognitive Assessment
Receive BrainCheck cognitive assessment
Other Name: BrainCheck

Procedure: Cognitive Assessment
Receive pen and paper cognitive assessment




Primary Outcome Measures :
  1. Completion rate of the BrainCheck battery [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% confidence interval (CI).

  2. Completion rate of the pen and paper assessment [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% CI.

  3. Average time to complete the BrainCheck battery [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% CI.

  4. Average time to complete the pen and paper assessment [ Time Frame: Up to 1 year ]
    Will be calculated along with a 95% CI.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678441


Contacts
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Contact: Thomas Aloia 713-792-6940 taaloia@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Thomas A. Aloia    713-792-6940      
Principal Investigator: Thomas A. Aloia         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Thomas A Aloia M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03678441     History of Changes
Other Study ID Numbers: 2018-0093
NCI-2018-01895 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0093 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bile Duct Diseases
Liver Diseases
Biliary Tract Diseases
Digestive System Diseases