Working Memory Performance Among Childhood Brain Tumor Survivors
NCT ID: NCT00693914
Last Updated: 2017-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
130 participants
OBSERVATIONAL
2007-04-30
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling controls using measures of working memory (online maintenance and manipulation of information) in order to identify a specific cognitive process that may underlie the observed decline in IQ. We are also exploring relationships among working memory performance with IQ, clinical characteristics and a specific genetic factor of interest.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
NCT01217996
Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
NCT05947045
Understanding the Late Effects of Surviving a Pediatric Brain Tumor
NCT03208387
Development of the Pediatric Neurocognitive Functioning Questionnaire
NCT03213431
Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors
NCT06227962
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1: Brain Tumor Survivors (n=50)
Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
2: Healthy Sibling Controls (n=40)
Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
Solid Tumor Survivors (n=40)
Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treated for a primary central nervous system (CNS) tumor with conformal radiation therapy and enrolled on the institutional protocol RT-1
* Initiated radiation therapy at least 2 years prior to enrollment with no evidence of recurrent disease
* Age 8-18 years inclusive at the time of enrollment, with sampling to obtain a broad cross-section of participants in terms of age, tumor location and time since RT initiation
* English as the primary language
* Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Solid Tumor Patient Controls
* Treated for a solid tumor (i.e., Ewing's sarcoma, osteosarcoma, soft tissue/rhabdomyosarcoma, neuroblastoma or Wilms tumor) at St. Jude without CNS directed therapy - Diagnosed at least 2 years prior to enrollment
* Age 8-18 inclusive at the time of enrollment, with age, gender and race sampling to broadly match the brain tumor group
* English as the primary language
* Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Sibling Controls
* Healthy sibling controls- siblings of St. Jude patients treated for a brain tumor (not necessarily on RT-1)
* Age 8-18 inclusive, with age and gender sampling to broadly match the patient group
* English as a primary language
* Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Exclusion Criteria
* Significant impairment in global intellectual functioning (operationalized as an estimated IQ less than 70 as indicated by most recent RT-1 testing)
* History of documented CNS injury or disease predating cancer diagnosis
* History of documented Attention Deficit Hyperactivity Disorder (ADHD) predating cancer diagnosis by at least one year (must have been diagnosed by a physician with medication prescribed)
* Treatment with psychostimulant or psychotropic medication within two weeks of study enrollment
* Sensory or motor impairment that would preclude valid cognitive testing
Solid Tumor and Sibling Controls
* Significant impairment in global intellectual functioning (operationalized as a history of special education in a self-contained classroom)
* History of documented CNS injury or disease
* History of documented Attention Deficit Hyperactivity Disorder (ADHD) (must have been diagnosed by a physician with medication prescribed)
* Treatment with psychostimulant or psychotropic medication within two weeks of study enrollment
* Sensory or motor impairment that would preclude valid cognitive testing
8 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heather M Conklin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
St. Jude Children's Research Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EXFXN1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.