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

Purpose:

RATIONALE: Learning about neurobehavioral function and quality of life over time in patients with cancer or other chronic disease may help doctors learn about the long-term effects of treatment and plan the best treatment. PURPOSE: This clinical trial is collecting and storing information over time from patients with cancer or other chronic disease who have undergone neurobehavioral assessments on another clinical trial.

Study summary:

OBJECTIVES: Primary - Determine the neurobehavioral function of patients with chronic illness by analyzing stored data collected from IRB-approved protocols comprising retrospective data collected on protocols that are now closed and prospective data from current and future protocols. Secondary - Determine the relationship between neurobehavioral functioning and medical, neuroimaging, neurologic, and psychiatric variables in these patients. - Determine the association of neurobehavioral functioning and medication adherence, life events, and family functioning in these patients. - Compare neurobehavioral measures between different subgroups within an illness group. - Determine the effects of treatment (e.g., antiretroviral therapy, radiation therapy) on neurobehavioral functioning over time in these patients. - Compare the responses of patients and caregivers on behavioral, adherence, and quality of life questionnaires. - Compare various aspects of neurobehavioral functioning between patients with different chronic medical conditions. - Validate novel assessment tools developed to better measure specific domains of functioning, such as quality of life and neurologic function in children with chronic illnesses with possible CNS involvement. OUTLINE: This is a longitudinal, retrospective, and prospective study. Retrospective data previously collected from patients enrolled on IRB-approved protocols is identified from the secure NCI/Medical Illness Counseling Center (MICC) neuropsychological database. Prospective data is collected from patients as specified in current or future IRB-approved protocols and entered in the secure NCI/MICC neuropsychological database within 1 month of assessment. Retrospective and prospective data collected from multisite IRB-approved protocols, that have a CCR investigator and the neurobehavioral data managed by NCI, may be included in analyses when appropriate. Various cross-sectional and/or longitudinal analyses are conducted on the selected data in the NCI/MICC neuropsychological database when appropriate. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Criteria:

DISEASE CHARACTERISTICS: - Any of the following diagnoses are allowed: - HIV positivity - Cancer (especially brain tumors and leukemia) - Neurofibromatosis type 1 - Data obtained from infants, children, adolescents, and adults who underwent neurobehavioral assessments as part of a past, current, or future IRB-approved protocol - No CNS condition (i.e., Down syndrome, severe intraventricular hemorrhage) not related to primary medical diagnosis (i.e., HIV, cancer) that may affect neurobehavioral functioning, missing values on a particular test being studied, or invalid data as determined by the investigator PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - Not specified

Study is Available At:

Original ID:

070110, CDR0000538241

NCT ID:

NCT00459199

Secondary ID:

NCI-07-C-0110

Study Acronym:

Brief Title:

Collecting and Storing Information From Patients With Cancer or Other Chronic Disease Who Have Undergone Neurobehavioral Assessments on Another Clinic

Official Title:

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

ClinicalTrials.gov Link:

http://clinicaltrials.gov/show/NCT00459199

Overall Status:

Recruiting

Study Phase:

N/A

Genders:

Both

Minimum Age:

N/A

Maximum Age:

N/A

Study Source:

National Institutes of Health Clinical Center (CC)

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Observational

Study Design:

N/A

Number of Arms:

0

Number of Groups:

0

Total Enrollment:

300

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: February 08, 2023

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