Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

May 19, 2015 updated by: Stanford University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance on neuropsychological testing and brain activation patterns measured by functional MRI
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Shelli Kesler, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 22, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-08123
  • 97817 (Other Identifier: Stanford University Alternate IRB Approval Number)
  • PEDSVAR0003 (Other Identifier: OnCore)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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