Working Memory Performance Among Childhood Brain Tumor Survivors

April 24, 2017 updated by: St. Jude Children's Research Hospital

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

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heather M Conklin, Ph.D., St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 9, 2008

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

October 1, 2011

More Information

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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