Bethesda, Maryland 20892

  • Neurofibromatosis Type

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


NCT ID:

NCT00459199


Primary Contact:

Study Chair
Pam Wolters, PhD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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