Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

NCT00490334 | Completed DMC

• 3 other identifiers: IRB-0812397817PEDSVAR0003
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Keywords

Carcinomas; Squamous Cel; Adenocarcinoma; Acute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Performance on neuropsychological testing and brain activation patterns measured by functional MRI

  8 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma; Adenocarcinoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shelli Kesler

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

US (1)