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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 7, 2018
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 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.

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

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 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.


Study Type : Observational
Estimated Enrollment : 755 participants
Official Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
Actual Study Start Date : September 15, 2008
Estimated Primary Completion Date : January 1, 2100

Group/Cohort Intervention/treatment
Observational (neuropsychological and behavioral tests)
Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-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.
Procedure: Cognitive Assessment
Complete COG Standard Neuropsychological and Behavioral Battery testing

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

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests [ Time Frame: Up to 60 months ]
  2. Utilization of standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials [ Time Frame: Up to 60 months ]
  3. Percentage of patients who completed the assessment [ Time Frame: Up to 60 months ]
    Calculated among all enrolled patients who have passed each assessment time point.



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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 180 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Leanne Embry Children's Oncology Group

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) )
COG-ALTE07C1
CDR0000594326
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 7, 2018
Last Verified: March 2016

Additional relevant MeSH terms:
Neoplasms