Development of the Pediatric Neurocognitive Functioning Questionnaire

NCT03213431 | Completed

• 1 other identifier: PNCQ-HPP22
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders

Keywords

Cancer survivors; Instrument development; Neurocognitive functioning; Patient-reported outcomes; Qualitative interview

Outcome Measures

Primary Outcomes (1)

• Number of participants who are capable of completing the survey

  Capability will be defined as the number of participants who complete the survey based on comprehension for the content of survey items.

  At completion of the survey, up to 6 months after study enrollment.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be childhood cancer survivors who are active After Completion of Therapy (ACT) patients consented to the SJLIFE clinical protocol and their parent/legal guardian.

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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• I-Chan Huang, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: July 12, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

US (1)