Neuropsychological and Behavioral Testing in Young Patients With Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET)

This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00772200
First received: October 14, 2008
Last updated: October 26, 2012
Last verified: October 2012

October 14, 2008
October 26, 2012
September 2008
October 2012   (final data collection date for primary outcome measure)
  • Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests [ Designated as safety issue: No ]
  • Utilization of standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00772200 on ClinicalTrials.gov Archive Site
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Neuropsychological and Behavioral Testing in Young Patients With Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET)
Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

RATIONALE: Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function in young patients with cancer.

PURPOSE: This clinical trial is studying neuropsychological and behavioral testing in young patients with medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET).

OBJECTIVES:

  • To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological and behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points in children with medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET).
  • To utilize a standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials to evaluate cognitive, social, emotional, and behavioral functioning over time.

OUTLINE: This is a multicenter study.

Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist. The Battery consists of tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function, adoptive function, and quality of life. Additionally, parents complete a parent-report questionnaire to gather information about patient's function in terms of attention, memory, executive abilities, and behavioral, social, and emotional adaption.

Observational
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  • Brain and Central Nervous System Tumors
  • Chemotherapeutic Agent Toxicity
  • Cognitive/Functional Effects
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • Therapy-related Toxicity
  • Other: questionnaire administration
  • Procedure: cognitive assessment
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
755
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October 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET)
  • Must be currently enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning

PATIENT CHARACTERISTICS:

  • Must have receptive and expressive English language skills
  • Patients with a history of severe or profound mental retardation (i.e., IQ < 50) are not eligible for enrollment

    • Children with a prior history of attention-deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
3 Years to 21 Years
No
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United States,   Australia,   Canada
 
NCT00772200
CDR0000594326, COG-ALTE07C1
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Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Leanne E. Segovia, PhD CHRISTUS Santa Rosa Children's Hospital
National Cancer Institute (NCI)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP