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: May 19, 2015
Last verified: May 2015
  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
Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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: 72
Study Start Date: August 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cancer patients
Children with cancer aged 8 to 16 years
Control (non-cancer)
Normal children aged 8 to 16 years, age- and gender-matched to the cancer cohort

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric cancer patients 8 to 16 years of age, with age- and gender-matched control group.

Criteria

INCLUSION

Everyone:

  • At least 9 years of age and less than 17 years

Patients

  • Diagnosis of brain tumor or acute lymphocytic leukemia (ALL)
  • Completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery

Control group

  • Typical for age

EXCLUSION

Everyone:

  • Non-English speaking (translated cognitive testing and MRI assessments unavailable)
  • MRI contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker
  • Major sensory deficit disorders, including but not limited to blindness or deafness

Patients

  • Shunt placement
  • Received bone marrow transplant
  • History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes) NOT related to cancer
  • Participation in any concurrent cognitive rehabilitation study

Control group

  • History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes)
  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: IRB-08123, 97817, PEDSVAR0003
Study First Received: June 20, 2007
Last Updated: May 19, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 03, 2015