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NCT03213431 · ClinicalTrials.gov registry record
Development of the Pediatric Neurocognitive Functioning Questionnaire
A clinical trial of Neurocognitive Disorders, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 42
- Enrollment target
- 1
- Study location
NCT03213431: Completed study of Neurocognitive Disorders, sponsored by St. Jude Children's Research Hospital.
NCT03213431 is a study of Neurocognitive Disorders that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 42 participants, below the 600-participant average among 8 other Neurocognitive Disorders trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03213431, a study of Neurocognitive Disorders, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine self-reported neurocognitive functioning in pediatric cancer survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy, and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies which are directed at the central nervous system (CNS) can lead to reduced volumes of normal-appearing white matter and neurocognitive dysfunction. Neurocognitive deficits can significantly impact pediatric cancer survivors' academic success, daily functional status, and quality of life. Previous studies demonstrate the need for screening and treating neurocognitive dysfunction in childhood cancer patients and survivors. This pilot study will conduct cognitive debriefing tests with childhood cancer survivors, 30 with and 10 without neurocognitive deficits, and their parents. The collected data will aid in developing a comprehensive patient-reported outcomes (PRO) toolkit consisting of generic and specific cognitive and behavioral domains that are content-appropriate and interface-friendly for pediatric cancer populations. PRIMARY OBJECTIVE: * To conduct cognitive debriefing tests with 30 pediatric cancer survivors who have global neurocognitive impairment (i.e., the impaired group) to understand the cognitive process of answering the extant pediatric PRO measures by different levels of general intelligence quotient (IQ). Additionally, 10 pediatric cancer survivors who have at least average general IQ (i.e., the unimpaired group) will be recruited for a comparison purpose. SECONDARY OBJECTIVE: * To conduct semi-structured interviews with 30 parents/legal guardians of individuals who have global cognitive impairment as described in the primary objective in order to explore the general concept of their child's neurocognitive functioning, to rank the relative importance of different neurocognitive functioning domains, to inform a strategy for communicating with children and adolescents with impai
Primary Outcome
Capability will be defined as the number of participants who complete the survey based on comprehension for the content of survey items.
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2017-12-08 |
What the finished NCT03213431 record still lists
NCT03213431 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 600-participant average among 8 other Neurocognitive Disorders trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Neurocognitive Disorders appearing as the primary indexed condition, and to 0 interventions.
NCT03213431 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03213431 about?
NCT03213431 is a clinical study titled "Development of the Pediatric Neurocognitive Functioning Questionnaire". This study will examine self-reported neurocognitive functioning in pediatric cancer survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy, and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies which are directed at the c...
What is the current status of trial NCT03213431?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2017-07-12. Estimated completion is 2017-12-08.
What conditions does trial NCT03213431 study?
This clinical trial studies the following conditions: Neurocognitive Disorders.
Who is sponsoring clinical trial NCT03213431?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03213431 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03213431's enrollment target sits among peer trials
42 6th of 8 higher than 3 of 8 other Neurocognitive Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurocognitive Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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