Neuropsychological and Behavioral Testing in Younger Patients With Cancer

  • Observational
  • Recruiting
  • NCT00772200
Eligibility Details Visit Clinicaltrials.gov

Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer.

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 testing at 9, 30, and 60 months post-diagnosis in a 1-2 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.

Gender
All

Age Group
1 Month to 21 Years

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT00772200

IRB#16698A

Lead SponsorChildren's Oncology Group

Lead PhysicianTara Henderson

Collaborator(s)N/A

EligibilityAll
1 Month to 21 Years
Recruiting