Neuropsychological and Behavioral Testing in Young Patients With Cancer

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00772200
First received: October 14, 2008
Last updated: February 24, 2014
Last verified: February 2014

October 14, 2008
February 24, 2014
September 2008
January 2100   (final data collection date for primary outcome measure)
  • Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Utilization of standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ]
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 Cancer
Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

This clinical trial is studying neuropsychological and behavioral testing in young patients with cancer. 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.

OBJECTIVES:

I. To utilize a standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with Children's Oncology Group (COG) Phase III clinical trials to evaluate cognitive, social, emotional, and behavioral functioning over time.

II. To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized timepoints.

OUTLINE:

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
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Patients diagnosed with cancer currently enrolled on COG therapeutic study.

  • Chemotherapeutic Agent Toxicity
  • Cognitive/Functional Effects
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Other: questionnaire administration
  • Procedure: cognitive assessment
  • Procedure: psychosocial assessment and care
    Other Names:
    • psychosocial assessment
    • psychosocial assessment/care
    • psychosocial care
    • psychosocial care/assessment
    • psychosocial studies
  • Procedure: quality-of-life assessment
    Other Name: quality of life assessment
Natural History (questionnaires)
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.
Interventions:
  • 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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January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of cancer
  • Must be currently enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning
  • Must have receptive and expressive English language skills
  • Patients with a history of severe or profound mental retardation (i.e. intelligence quotient [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
  • All patients and/or their parents or legal guardians must sign a written informed consent
Both
1 Month to 21 Years
No
Not Provided
United States,   Australia,   Canada,   New Zealand
 
NCT00772200
ALTE07C1, NCI-2009-00383, COG-ALTE07C1, CDR0000594326, ALTE07C1, ALTE07C1, U10CA098543
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Leanne Embry, MD Children's Oncology Group
Children's Oncology Group
February 2014

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