Clinical trial NCT00873132: BTC Neuropsychological Database
Official title: BTC Neuropsychological Database:Prospective Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Tumor
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For those patients enrolled, we will conduct analysis on data that is gathered during neuropsychological testing visits to better describe the pattern of neurocognitive deficits typically seen in our patient population and to publish our findings with the goal of informing a larger scientific community.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Data collected both retrospectively and prospectively, by consent, on subjects with brain tumors seen in the Preston Robert Tisch Brain Tumor Center (PRTBTC).
* Retrospective dates will be 3/1/06 through the approval date for the prospective component of this study.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Bivariate correlational analyses will be conducted to examine associations between neuropsychological, depression, demographic, medication data tumor-related treatment , and QoL variables.
timeFrame: 5years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Renee Raynor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: