Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01445314
First received: September 30, 2011
Last updated: July 10, 2014
Last verified: June 2014
  Purpose

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.

Condition
HIV
Brain Tumors
Neurofibromatosis 1

Study Type: Observational
Official Title: Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Describe neurobehavioural functioning based on stored data [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between neurobehavioral functioning & amp; medical, neuroimaging, neurologic, and psychiatric variables [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Association of neurobehavioral functioning with medication. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Compare neurobehavioral measures between different subgroups within [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Effects of treatment on neurobehavioral functioning over time [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Compare the responses of the patient and caregiver on behavioral adherence & amp; QOL [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Compare neurobehavioral functioning between different chronic medical conditions [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Validate novel assessment tools [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: February 2007
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.

Objectives:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445314

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Pamela L Wolters, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01445314     History of Changes
Obsolete Identifiers: NCT00459199
Other Study ID Numbers: 070110, 07-C-0110
Study First Received: September 30, 2011
Last Updated: July 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Stored Data
Neurobehavioral
Behavior
Quality of Life

Additional relevant MeSH terms:
Brain Neoplasms
Neurofibromatoses
Neurofibromatosis 1
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 21, 2014