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Trial record 1 of 2 for:    COG ALTE07C1
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Neuropsychological and Behavioral Testing in Younger Patients With Cancer

This study is currently recruiting participants.
Verified October 2017 by Children's Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772200
First Posted: October 15, 2008
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
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 Intervention
Chemotherapeutic Agent Toxicity Childhood Cancer Cognitive/Functional Effects Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Procedure: psychosocial assessment and care Procedure: cognitive assessment Other: quality-of-life assessment Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests [ Time Frame: Up to 60 months ]
  • 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 ]
  • 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.


Estimated Enrollment: 755
Study Start Date: September 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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: psychosocial assessment and care
Complete COG Standard Neuropsychological and Behavioral Battery testing
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
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

Detailed Description:

OBJECTIVES:

I. To utilize a standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with Children's Oncology Group (COG) Phase 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 timepoints.

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-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.

  Eligibility

Information from the National Library of Medicine

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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
Study Population
Patients on COG Phase III clinical trials.
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 English language skills

Exclusion Criteria:

  • Patients with a history of severe or profound mental retardation (i.e. intelligence quotient [IQ] =< 50) 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
  Contacts and Locations
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 156 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Leanne Embry Children's Oncology Group
  More Information

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 ( Other Identifier: Children's Oncology Group )
CDR0000594326 ( Other Identifier: Clinical Trials.gov )
ALTE07C1 ( Other Identifier: Children's Oncology Group )
ALTE07C1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 14, 2008
First Posted: October 15, 2008
Last Update Posted: October 23, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders