Neuropsychological and Behavioral Testing in Younger Patients With Cancer

  • STATUS
    Recruiting
  • participants needed
    1200
  • sponsor
    Children's Oncology Group
Updated on 25 January 2021
John Hunter Children's Hospital (2.5 mi away) Contact
+90 other location

Summary

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.

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.

Details
Condition Toxic encephalopathy, Pediatric Cancer, Childhood Cancer, Psychosocial Effects of Cancer and Its Treatment, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Radiation Toxicity, Cognitive Side Effects of Cancer Therapy, Childhood Malignant Neoplasm
Treatment questionnaire administration, psychosocial assessment and care, quality-of-life assessment, cognitive assessment
Clinical Study IdentifierNCT00772200
SponsorChildren's Oncology Group
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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