Working Memory Performance Among Childhood Brain Tumor Survivors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00693914
First received: June 5, 2008
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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 Intervention
Brain Tumors
Behavioral: Series of tests/questionnaires

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Performance on experimental working memory measures (computerized self-ordered pointing tasks) [ Time Frame: Collected during one time cross-sectional assessment. ] [ Designated as safety issue: No ]

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. [ Time Frame: Collected during one time cross-sectional assessment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Both the patient group and sibling group will be accrued using a broad stratification process for gender (Male, Female) and age (8-12 years of age, 13-18 years of age).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693914

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Heather M Conklin, Ph.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00693914     History of Changes
Other Study ID Numbers: EXFXN1, R21CA131616
Study First Received: June 5, 2008
Last Updated: October 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Brain Tumor
Cognitive Late Effects
Radiation Therapy
Working Memory

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014