Development of the Pediatric Neurocognitive Functioning Questionnaire

Completed

Conditions studied: Neurocognitive Disorders

In brief

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 impaired neurocognitive functioning for PRO research, and to suggest a user-friendly interface to collect PRO data from cognitively impaired children and adolescents. Additionally, 10 parents/legal guardians of individuals at least average general IQ will be recruited for comparison.

Key facts

Study ID

NCT03213431

Run by

St. Jude Children's Research Hospital

People needed

42

Starts

2017-07-12

Expected to finish

2017-12-08

Last updated by the study team

2018-03-27

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cancer survivors who are off cancer therapies;
• Children/youth age 8-17.9 years and their parents/legal guardians (i.e. dyads);
• Impaired and unimpaired general IQs (IQ 40-89 for impaired and IQ ≥90 for unimpaired); AND
• English speaking participants.

You may not qualify if…

• Only the child/adolescent or the parent is able to participate (i.e. non-dyads);
• Severe/profound IQ deficits (IQ <40); AND
• Non-English speaking participants.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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