Working Memory Performance Among Childhood Brain Tumor Survivors

Sponsor

St. Jude Children's Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00693914

Collaborator

National Cancer Institute (NCI) (NIH)

130

Enrollment

Location

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumors	Behavioral: Series of tests/questionnaires

Detailed Description

This is a cross-sectional controlled study of brain tumor survivors treated at St. Jude with conformal radiation therapy. Brain tumor survivors (n= 50, solid tumor survivors (n=40), and healthy sibling controls (n= 40) are evaluated once only with laboratory measures of cognitive skills (working memory, episodic memory and estimated IQ) and parental questionnaires (executive and adaptive functions). We also use buccal (cheek) swabs to gather samples for DNA extraction. We hypothesize: brain tumor survivors will perform significantly worse than solid tumor and healthy controls on measures of working memory, working memory will correlate significantly with IQ, working memory will be associated with parent report of executive functions and a specified genotype related to dopamine metabolism will be associated with working memory impairment.

Study Design

Study Type:

Observational

Actual Enrollment :

130 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Working Memory Performance Among Childhood Brain Tumor Survivors Treated With Conformal Radiation Therapy: A Pilot Study

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
1: Brain Tumor Survivors (n=50)	Behavioral: 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)	Behavioral: 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)	Behavioral: 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

Arm

Intervention/Treatment

1: Brain Tumor Survivors (n=50)

Behavioral: 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)

Behavioral: Series of tests/questionnaires

Solid Tumor Survivors (n=40)

Behavioral: Series of tests/questionnaires

Outcome Measures

Primary Outcome Measures

Performance on experimental working memory measures (computerized self-ordered pointing tasks) [Collected during one time cross-sectional assessment.]

Secondary Outcome Measures

Abbreviated IQ (WASI), episodic memory measures (computerized word and face recognition tasks) and parent questionnaires of executive (BRIEF) and adaptive (ABAS-II) functioning. [Collected during one time cross-sectional assessment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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