Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Other Indications, Brain Cancer, HIV / AIDS, Neurology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Oncology, Other |
| Healthy: | No |
| Age Range: | Any - 100 |
| Updated: | 4/6/2019 |
| Start Date: | March 23, 2007 |
Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols
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.
- 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.
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.
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.
- 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.
We found this trial at
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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