Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

Neoplasms Clinical Trial

Official title:

Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490334
• Other study ID #: IRB-08123
• Secondary ID: 97817PEDSVAR0003
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: May 19, 2015
• Start date: August 2007
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 16 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Neoplasms

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on neuropsychological testing and brain activation patterns measured by functional MRI		8 weeks	No