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Neuropsychological and Behavioral Testing in Younger Patients With Cancer

C

Children's Oncology Group

Status

Active, not recruiting

Conditions

Childhood Malignant Neoplasm

Treatments

Procedure: Cognitive Assessment
Other: Quality-of-Life Assessment

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT00772200
ALTE07C1 (Other Identifier)
U10CA180886 (U.S. NIH Grant/Contract)
CDR0000594326
UG1CA189955 (U.S. NIH Grant/Contract)
U10CA098543 (U.S. NIH Grant/Contract)
COG-ALTE07C1
UG1CA189958 (U.S. NIH Grant/Contract)
NCI-2009-00383 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

1+ month old

Volunteers

No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Observational (neuropsychological and behavioral tests)
Description:
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.
Treatment:
Other: Quality-of-Life Assessment
Procedure: Cognitive Assessment

Trial contacts and locations

184

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Data sourced from clinicaltrials.gov

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