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
  Purpose

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).


Condition Intervention
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

Study Type: Observational
Official Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 755
Study Start Date: September 2008
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772200

  Show 119 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Leanne E. Segovia, PhD CHRISTUS Santa Rosa Children's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00772200     History of Changes
Other Study ID Numbers: CDR0000594326, COG-ALTE07C1
Study First Received: October 14, 2008
Last Updated: October 26, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
chemotherapeutic agent toxicity
neurotoxicity
radiation toxicity
therapy-related toxicity
cognitive/functional effects
psychosocial effects of cancer and its treatment
recurrent childhood medulloblastoma
untreated childhood medulloblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
untreated childhood supratentorial primitive neuroectodermal tumor

Additional relevant MeSH terms:
Medulloblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neurotoxicity Syndromes
Radiation Injuries
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Poisoning
Substance-Related Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013