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Neuropsychological and Behavioral Testing in Younger Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00772200
Recruitment Status : Recruiting
First Posted : October 15, 2008
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

Condition or disease Intervention/treatment
Childhood Malignant Neoplasm Cognitive Side Effects of Cancer Therapy Procedure: Cognitive Assessment Other: Quality-of-Life Assessment

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.


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Study Type : Observational
Estimated Enrollment : 755 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
Actual Study Start Date : September 15, 2008

Group/Cohort Intervention/treatment
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.
Procedure: Cognitive Assessment
Complete COG Standard Neuropsychological and Behavioral Battery

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests [ Time Frame: Up to 72 months post-diagnosis ]
  2. Utilization of standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials [ Time Frame: Up to 72 months post-diagnosis ]


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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cancer enrolled on a COG therapeutic study
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772200


  Show 184 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Leanne M Embry Children's Oncology Group

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00772200     History of Changes
Other Study ID Numbers: ALTE07C1
NCI-2009-00383 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000594326
COG-ALTE07C1
ALTE07C1 ( Other Identifier: Childrens Oncology Group )
ALTE07C1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Neoplasms