BTC Neuropsychological Database
Purpose and Objective:
The purpose of this study is to collect data both retrospectively and prospectively, by consent, on subjects seen in the PRTBTC. This information will be useful to the investigators to generate hypotheses for planning further psychosocial and medication intervention studies that will hopefully improve primary brain tumor patients' QOL.
|Study Design:||Observational Model: Cohort|
|Official Title:||BTC Neuropsychological Database:Prospective Study|
- Bivariate correlational analyses will be conducted to examine associations between neuropsychological, depression, demographic, medication data tumor-related treatment , and QoL variables. [ Time Frame: 5years ] [ Designated as safety issue: No ]
- In exploratory analyses, FACT-BR scale scores will be regressed on candidate neurocognitive predictors while controlling for other potentially confounding variables using hierarchical regression analyses. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Collect data both retrospectively and prospectively on subjects seen at the Preston Robert Tisch Brain Tumor Center
Study Activities and Population Group:
Retrospective dates will be 3/1/06 through the approval date for the prospective component of this study. The data will be neurocognitive, depression, tumor-related, overall quality of life (QOL), treatment, and demographic variables. The investigators research aims are to
- compute correlations among these different variables
- to test significant predictors of QOL. The investigators also will conduct a retrospective review of all brain tumor patients evaluated at the neuropsychology clinic at the PRT-BTC from the date that this prospective study is approved back to 3/20/2006.
Data Analysis and Risk/Safety Issues:
The medical record review does not present any obvious source of risk or discomfort to patients and their families. For both the retrospective and prospective components of the study, as the data for the proposed study were already collected as a part of the standard of care at the Preston Robert Tisch Brain Tumor Center at Duke, there are no additional risks to the study sample as a result of data collection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873132
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Renee Raynor, Ph.D.||Duke University|