Neuropsychological and Behavioral Testing in Young Patients With Cancer
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Purpose
This clinical trial is studying neuropsychological and behavioral testing in young patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function in young patients with cancer.
| Condition | Intervention |
|---|---|
|
Chemotherapeutic Agent Toxicity Cognitive/Functional Effects Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Unspecified Childhood Solid Tumor, Protocol Specific |
Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer |
- Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
- Utilization of standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Natural History (questionnaires)
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 a quality-of-life assessment. 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.
|
Other: questionnaire administration
Testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist
Procedure: cognitive assessment
Tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function and adoptive function
Procedure: psychosocial assessment and care
Other Names:
Procedure: quality-of-life assessment
Other Name: quality of life assessment
|
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| Ages Eligible for Study: | 1 Month to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with a diagnosis of cancer whom is currently enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning and have receptive and expressive English language skills
Inclusion Criteria:
- Diagnosis of cancer
- Must be currently enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning
- Must have receptive and expressive English language skills
Patients with a history of severe or profound mental retardation (i.e. intelligence quotient [IQ] =< 50) are not eligible for enrollment
- Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g. dyslexia) are eligible for this study
- All patients and/or their parents or legal guardians must sign a written informed consent
Contacts and Locations
Show 137 Study Locations| Principal Investigator: | Leanne Embry | Children's Oncology Group |
More Information
No publications provided
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00772200 History of Changes |
| Other Study ID Numbers: | ALTE07C1, NCI-2009-00383, COG-ALTE07C1, CDR0000594326, U10CA098543 |
| Study First Received: | October 14, 2008 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neurotoxicity Syndromes Radiation Injuries Nervous System Diseases |
Poisoning Substance-Related Disorders Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013