PNCQ: Developing a Neurocognitive Questionnaire for Childhood Cancer Survivors

Assessing Patient-Reported Neurocognitive Functioning in Pediatric Oncology: A Pilot Study Toward Developing the Pediatric Neurocognitive Questionnaire (PNCQ)

Categories:

Psychology

Quality of Life

Diseases Treated:

Cancer

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.

  • 8 to 17.9 years old
  • Cancer survivor who is off cancer therapy
  • Parents and legal guardians of children to also enroll in the study
  • Speaks English

 

  1. Brief Summary

    Evidence has shown that central nervous system-directed therapies (including cranial radiation therapy, intrathecal chemotherapy and high dose intravenous antimetabolite chemotherapy) administered to pediatric cancer patients can lead to reduced volumes of normal-appearing white matter and neurocognitive dysfunction. Neurocognitive deficits can significantly impact childhood cancer survivors’ academic success, daily functional status and quality of life.

    In childhood cancer survivors, neurocognitive impairment limits the child’s ability to learn new skills needed for living independently.  Early-stage functional impairments are difficult to evaluate during routine office visits, and direct assessments conducted in a controlled testing environment may not reflect daily functional expectations. Instead, the use of patient-reported outcomes (PROs) to evaluate neurocognitive functioning in one’s natural environment may predict problems before they can be detected by direct assessment. To date, very few PRO tools have been developed to assess neurocognitive function in children who have received treatment for cancer.

    The aim of this pilot study is to conduct cognitive debriefing tests with St. Jude childhood cancer survivors (with and without neurocognitive deficits) and their parents; and to administer patient-reported outcome (PRO) tools. These tools will include the Child Health and Illness Profile-Child Edition/Child Report Form, Applied Cognition scale of the Neuro-QOL and Pediatric Perceived Cognition Function. The long-term goal is to develop a comprehensive PRO toolkit that is 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 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.

    Eligibility Criteria

    This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.

    Inclusion criteria include:

    • 8 to 17.9 years old
    • Cancer survivor who is off cancer therapy
    • Parents and legal guardians of children to also enroll in the study
    • Speaks English

    Exclusion criteria include:

    • Only the child/adolescent or the parent is able to participate
    • Severe/profound IQ deficits
    • Does not speak English

    Study Site

    St. Jude Children’s Research Hospital, Memphis, Tennessee

  2. About this study

    Treatment for childhood cancer can sometimes cause long-term cognitive (thinking, memory, attention) problems in survivors. For example, some survivors may misunderstand questions or have trouble remembering information. These types of thinking problems can cause difficulty in school and daily life. They can also limit a child’s ability to learn new skills needed to live independently.

    Using patient self-reported health measures may predict these kinds of problems before they can be detected by cognitive testing. A self-reported health measure is a type of survey that asks you to answer questions about your own health.

    In this study, researchers will conduct cognitive interviews with survivors to see how well they understand and respond to patient-reported health measures. The results will help researchers decide if these patient-reported health measures are useful for cancer survivors with thinking problems.

    Purpose of this clinical trial

    The main goal of this study is to understand how childhood cancer survivors answer patient-reported health measures. Researchers also want to talk with survivors’ parents to find out if their children are having trouble thinking and reasoning. The results from this study will be used to develop a toolkit that may help identify thinking problems in survivors sooner.

    Eligibility overview

    • 8 to 17.9 years old
    • Cancer survivor who is off cancer therapy
    • Parents and legal guardians of children to also enroll in the study
    • Speaks English
  3. PNCQ Quick View
    Sponsors St. Jude Children's Research Hospital
    ClinicalTrials.gov identifier NCT03213431
    Trial Start Date June 2017
    Estimated Enrollment 40
    Study Type Observational
    Conditions Cancer survivor
    Ages 8 to 17.9 years old
    Principal investigator I-Chan Huang, PhD
    Study Sites St. Jude Children's Research Hospital 
    For a consultation or to discuss PNCQ St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.