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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01895 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0093 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (BrainCheck and paper and pen cognitive assessment) | Experimental | 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. |
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| Group II (pen and paper and BrainCheck cognitive assessment) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainCheck Cognitive Assessment | Behavioral | Receive BrainCheck cognitive assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of the BrainCheck battery | Will be calculated along with a 95% confidence interval (CI). | Up to 1 year |
| Completion rate of the pen and paper assessment | Will be calculated along with a 95% CI. | Up to 1 year |
| Average time to complete the BrainCheck battery | Will be calculated along with a 95% CI. | Up to 1 year |
| Average time to complete the pen and paper assessment | Will be calculated along with a 95% CI. | Up to 1 year |
| Difference in completion rate between the BrainCheck battery and paper and pen assessment | Will be calculated along with 95% CIs. | Up to 1 year |
| Difference in time to completion between the BrainCheck battery and the pen and paper assessment | Will be calculated along with 95% CIs. | Up to 1 year |
| Difference in score between the BrainCheck battery and the pen and paper assessments | Will be calculated along with 95% CIs. | Up to 1 year |
| 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) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Newhook, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Assessment | Procedure | Receive pen and paper cognitive assessment |
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Will be calculated along with 95% CIs. |
| Up to 1 year |