Working Memory Performance Among Childhood Brain Tumor Survivors

NCT00693914 | Completed

• 2 other identifiers: EXFXN1R21CA131616
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumors

Keywords

Brain Tumor; Cognitive Late Effects; Radiation Therapy; Working Memory

Outcome Measures

Primary Outcomes (1)

• Performance on experimental working memory measures (computerized self-ordered pointing tasks)

  Collected during one time cross-sectional assessment.

Secondary Outcomes (1)

• 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.

Study Arms (3)

1: Brain Tumor Survivors (n=50)

Behavioral: Series of tests/questionnaires

2: Healthy Sibling Controls (n=40)

Behavioral: Series of tests/questionnaires

Solid Tumor Survivors (n=40)

Behavioral: Series of tests/questionnaires

Interventions

Series of tests/questionnaires BEHAVIORAL

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

1: Brain Tumor Survivors (n=50); 2: Healthy Sibling Controls (n=40); Solid Tumor Survivors (n=40)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Heather M Conklin, Ph.D.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: April 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 25, 2017

Record last verified: 2011-10

Locations

US (1)