Clinical Trials /

Neuropsychological and Behavioral Testing in Younger Patients With Cancer

NCT00772200

Description:

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • Brief Title: Neuropsychological and Behavioral Testing in Younger Patients With Cancer
  • Official Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

Clinical Trial IDs

  • ORG STUDY ID: ALTE07C1
  • SECONDARY ID: NCI-2009-00383
  • SECONDARY ID: CDR0000594326
  • SECONDARY ID: COG-ALTE07C1
  • SECONDARY ID: ALTE07C1
  • SECONDARY ID: ALTE07C1
  • SECONDARY ID: U10CA180886
  • SECONDARY ID: U10CA098543
  • SECONDARY ID: UG1CA189955
  • SECONDARY ID: UG1CA189958
  • NCT ID: NCT00772200

Conditions

  • Childhood Malignant Neoplasm
  • Cognitive Side Effects of Cancer Therapy

Purpose

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To utilize a standardized battery of age-appropriate neuropsychological and behavioral
      tests in conjunction with Children's Oncology Group (COG) Phase II and 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 time
      points.

      OUTLINE:

      Parent and child participants complete the COG Standard Neuropsychological and Behavioral
      Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session
      conducted by a neuropsychologist or psychologist. The Battery consists of measures of
      intelligence, processing speed, attention, memory, language preference,
      behavioral/social/emotional function, executive function, adaptive function, and quality of
      life.
    

Trial Arms

NameTypeDescriptionInterventions
Observational (neuropsychological and behavioral tests)Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic
                 study that aims to examine neuropsychological, social, emotional, and/or behavioral
                 functioning
    
              -  The patient must have receptive and expressive language skills in English, French, or
                 Spanish; if a patient meets these criteria but the parent/guardian speaks a language
                 other than English, French, or Spanish, the patient may still be enrolled and tested,
                 and the parent-report measures should be omitted
    
              -  All patients and/or their parents or legal guardians must sign a written informed
                 consent
    
              -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
                 (NCI) requirements for human studies must be met
    
            Exclusion Criteria:
    
              -  Patients with a history of moderate to profound intellectual disability (i.e.
                 intelligence quotient [IQ] =< 55) are not eligible for enrollment; PLEASE NOTE:
                 Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a
                 specific learning disability (e.g. dyslexia) are eligible for this study
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:1 Month
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests
    Time Frame:Up to 72 months post-diagnosis
    Safety Issue:
    Description:

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Children's Oncology Group

    Last Updated