Development of the Pediatric Neurocognitive Functioning Questionnaire

NCT ID: NCT03213431

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-12
• Study Completion Date: 2017-12-08

Brief 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 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.

Detailed Description

Pediatric participants will undergo a 30-45 minute cognitive interview including three sections:

1. Introduction to the study and warm-up debriefing exercise.

2. Determination of participant's level of understanding by arranging circles of different sizes.

3. Completion of individual surveys including the Child Health & Illness Profile-Child Edition/Child Report Form (CHIP-CE/CRF), the Applied Cognition scale of the Neuro-QOL, and the Pediatric Perceived Cognitive Function (PedPCF - Child).

For patient participants who have not had IQ testing within the prior 3 years, IQ testing may be repeated.

Semi-structured interviews will be conducted with parents/legal guardians of pediatric participants including:

1. Open-ended questions to help researchers understand whether their child is able to complete the CHIP-CE/CRF, Applied Cognition scale of the Neuro-QOL, and the PedPCF - Child.

2. Concerns they may have about cognitive functioning issues and its importance for their child. They will also be asked their thoughts on how to communicate and interact effectively with children and adolescents who have cognitive delays and their feedback about a user-friendly way to collect patient-reported health data.

3. The pediatric participant responses will be compared with their parent/legal guardian responses to confirm the answers were accurate and to evaluate whether the child can recall appropriate information for a given time frame.

Interviews will be conducted primarily on the St. Jude campus, or via Skype video meeting as a secondary option.

Conditions

Neurocognitive Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IQ of <90 and ≥40

Patient-Reported Outcomes (PRO) will be evaluated in a group of 30 childhood cancer survivors with global neurocognitive impairment classified by IQ of \<90 and ≥40 and 30 of their parents.

No interventions assigned to this group

IQ of ≥90

Patient-Reported Outcomes (PRO) will be evaluated in a group of 10 childhood cancer survivors with global neurocognitive unimpairment classified by IQ of ≥90 and 10 of their parents.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I-Chan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

PNCQ-HPP22

Identifier Type: -

Identifier Source: org_study_id