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Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

This study is currently recruiting participants.
Verified January 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00490334
First received: June 20, 2007
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

This research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.


Condition Intervention
Neoplasms
 Behavioral: Cognitive rehabilitation
Device: MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Performance on neuropsychological testing and brain activation patterns measured by functional MRI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2007
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive rehabilitation Behavioral: Cognitive rehabilitation
Standard of Care
Other Name: Cognitive rehabilitation therapy
Device: MRI
Standard of Care
Other Name: Magnetic Resonance Imaging

Detailed Description:

The purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 5 children with any type of cancer in the initial stages of chemotherapy and/or cranial radiation.
  • 10 children with any type of cancer who have completed chemotherapy and cranial radiation.

Exclusion Criteria:

  • Children with pre-cancer/pre-chemotherapy history of brain injury, neurological, psychiatric, neurodevelopmental and/or learning disorders including attention deficit hyperactivity disorder will be excluded.
  • Participants will be excluded for MRI contraindications such as orthodontia and biomedical implants.
  • Non-English speaking participants will be excluded due to the unavailability at this time of translated cognitive testing and MRI assessments.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490334

Contacts
Contact: Shelli Kesler, PhD (650) 723-0058 skesler@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Shelli Kesler, PhD     650-723-0058     skesler@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Shelli Kesler            
Sub-Investigator: Allan L Reiss            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Shelli Kesler Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00490334     History of Changes
Other Study ID Numbers: PEDSVAR0003, 97817, PEDSVAR0003
Study First Received: June 20, 2007
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Carcinomas
Squamous Cel
Adenocarcinoma
Acute Lymphocytic Leukemia

Additional relevant MeSH terms:
Neoplasms
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013