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

  • participants needed
  • sponsor
    National Cancer Institute (NCI)
Updated on 7 November 2020


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.

Condition Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Leukemia, Long-term Effects Secondary to Cancer Therapy in Adults, Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma, Metastatic Cancer, Neurofibromatosis Type 1, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Treatment psychosocial assessment and care, quality-of-life assessment, management of therapy complications, physiologic testing, cognitive assessment
Clinical Study IdentifierNCT00459199
SponsorNational Cancer Institute (NCI)
Last Modified on7 November 2020


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