- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693914
Working Memory Performance Among Childhood Brain Tumor Survivors
Working Memory Performance Among Childhood Brain Tumor Survivors Treated With Conformal Radiation Therapy: A Pilot Study
Children treated with radiation therapy for brain tumors are at risk for cognitive problems. These problems have typically been demonstrated on global cognitive measures including measures of intellectual functioning (IQ). Identification of specific areas of impairment can assist in isolating vulnerable brain areas and developing targeted interventions.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Brain Tumor Patients
- 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:
Brain Tumor Patients
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1: Brain Tumor Survivors (n=50)
|
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)
|
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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Performance on experimental working memory measures (computerized self-ordered pointing tasks)
Time Frame: Collected during one time cross-sectional assessment.
|
Collected during one time cross-sectional assessment.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Abbreviated IQ (WASI), episodic memory measures (computerized word and face recognition tasks) and parent questionnaires of executive (BRIEF) and adaptive (ABAS-II) functioning.
Time Frame: Collected during one time cross-sectional assessment.
|
Collected during one time cross-sectional assessment.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heather M Conklin, Ph.D., St. Jude Children's Research Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXFXN1
- R21CA131616 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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