Development of the Pediatric Neurocognitive Functioning Questionnaire
Condition: Neurocognitive Disorders
MeSH terms: Neurocognitive Disorders
Study type: Observational

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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Cancer survivors; Instrument development; Neurocognitive functioning; Patient-reported outcomes; Qualitative interview