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

Official Title: “Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols”

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.

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.

Intervention(s) in this Clinical Trial

• Other: physiologic testing
• Procedure: cognitive assessment
• Procedure: management of therapy complications
• Procedure: psychosocial assessment and care
• Procedure: quality-of-life assessment

Primary Measures

• Neurobehavioral function

Secondary Measures

• Relationship between neurobehavioral test scores, medical variables, environmental factors, and demographic characteristics
• Comparison of neurobehavioral measures between different subgroups of patients with varying levels of clinical, immunological, and virologic status
• Changes in psychometric test scores over time

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Cancer Institute (NCI) NIH

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00459199

Study ID Number: 070110, CDR0000538241

ClinicalTrials.gov Identifier: NCT00459199

Health Authority: Unspecified