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Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00490334
First received: June 20, 2007
Last updated: November 24, 2014
Last verified: November 2014
  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:


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 ]

Enrollment: 23
Study Start Date: August 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490334

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
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: November 24, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014