Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

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Brief Title

Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

Official Title

Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols

Brief Summary

      Background:

        -  People with chronic illness often are at risk for developing neurobehavioral problems
           due to effects of the disease or associated treatments. These problems may include
           cognitive impairments involving problem-solving, remembering things, paying attention,
           and understanding and using language, or emotional functioning or quality of life.

        -  The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group
           has collected data from neurobehavioral evaluations of infants, children, adolescents
           and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to
           collect data from patients enrolled in current protocols.

        -  The data from these evaluations, along with demographic and medical information are
           stored in an NIH computer database.

        -  Investigating the neurobehavioral functioning of patients with chronic illness is
           important for identifying and monitoring the effects of the disease and treatments over
           time, determining possible at-risk subgroups, evaluating response to therapy, and
           recommending educational and rehabilitative interventions.

      Objectives:

      -To learn about how certain illnesses or treatments may affect a person s cognitive
      abilities, emotional functioning and quality of life.

      Eligibility:

        -  Patients currently enrolled in NIH studies who are having neuropsychological testing or
           completing quality-of-life questionnaires as part of that study.

        -  Data obtained from infants, children, adolescents, and adults administered
           neurobehavioral assessments as part of a past or future NIH protocol.

      Design:

        -  This study does not involve any extra tests or questionnaires; it uses information
           collected from evaluations that subjects have already completed or will complete as part
           of other NIH studies.

        -  Information about participating patients that may help elucidate how cognitive
           abilities, emotional functioning, and quality of life are affected in people with
           chronic illness may be collected and stored.
    

Detailed Description

      Background:

      Individuals with chronic illness often are at risk for developing neurobehavioral impairments
      due to effects of the disease and/or associated treatments.

      The National Cancer Institute (NCI) Neurobehavioral Group has been collecting neurobehavioral
      data obtained from the longitudinal psychometric testing of infants, children, adolescents,
      and adults with various chronic illnesses enrolled on IRB-approved protocols at the NIH since
      the 1980 s, many of which are now closed. In addition, we continue to collect neurobehavioral
      data obtained from assessments of individuals enrolled on current IRB-approved protocols.

      The neurobehavioral test data from these evaluations, as well as demographic information,
      medical values, neurologic findings, and neuroimaging abnormalities, are stored in the
      neuropsychological database currently located on the secure NIH mainframe computer system.

      Investigating the neurobehavioral functioning of children with chronic illness is important
      for identifying and monitoring the effects of the disease and treatments over time,
      determining possible at-risk subgroups, evaluating response to therapy, and recommending
      educational and rehabilitative interventions. In addition, the data may be used to compare
      various aspects of neurobehavioral functioning among different illness groups healthy
      controls, and validate novel methodologies to better assess selected domains of functioning,
      such as a pediatric quality of life (QOL) scale for children with chronic illnesses with CNS
      involvement.

      Objective:

      To describe the neurobehavioral functioning of individuals with chronic illness based on the
      analysis of stored data collected from IRB-approved protocols, consisting of retrospective
      data collected on protocols that are now closed and data collected prospectively on current
      and future protocols.

      Eligibility:

      Data obtained from infants, children, adolescents, and adults administered neurobehavioral
      assessments as part of a past, current, or future IRB-approved protocol.

      Design:

      No data will be collected specifically for this protocol. Retrospective data previously
      collected from individuals receiving neurobehavioral assessments as part of past IRB-approved
      protocols or prospective data that already will be collected as specified in current or
      future IRB-approved protocols and stored in the secure NCI Neurobehavioral database will be
      used for data analysis as outlined in this protocol.

      Cross-sectional or longitudinal data will be selected from the database for statistical
      analysis based on the objective being studied. Since different objectives may be studied
      using various types of data, a variety of statistical analyses will be conducted to examine
      the stored data depending on the objective being studied.
    


Study Type

Observational


Primary Outcome

Functional

Secondary Outcome

 Relationship

Condition

HIV


Study Arms / Comparison Groups

 1/ Patients
Description:  Infants, children, adolescents, and adults who have taken neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

720

Start Date

March 23, 2007



Eligibility Criteria

        -  INCLUSION CRITERIA:

               1. Data obtained from infants, children, adolescents, and adults administered
                  neurobehavioral assessments as part of a past, current, or future IRB-approved
                  protocol.

               2. Informed consent for subjects greater than or equal to 18 years of age, a legal
                  representative to provide permission for subjects greater than or equal to 18
                  years who cannot give informed consent, or one parent-legal guardian to provide
                  permission for subjects less than 18 years of age who are administered
                  neurobehavioral assessments after this protocol is approved.

               3. Data obtained from healthy controls, which may be siblings of affected patients,
                  administered neurobehavioral assessments on an IRB-approved protocol.

        EXCLUSION CRITERIA:

        1. Data may be excluded from a particular analysis if a subject had a CNS condition (i.e.,
        Down s syndrome, severe intraventricular hemorrhage) not related to their primary medical
        diagnosis (i.e., HIV, cancer) that may affect neurobehavioral functioning, missing values
        on a particular test being studied, or invalid data as judged by the PI or Chairperson.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Pamela L Wolters, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01445314

Organization ID

070110

Secondary IDs

07-C-0110

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Pamela L Wolters, Ph.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

August 31, 2021