Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

NCT ID: NCT00490334

Last Updated: 2015-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients

Children with cancer aged 8 to 16 years

No interventions assigned to this group

Control (non-cancer)

Normal children aged 8 to 16 years, age- and gender-matched to the cancer cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shelli Kesler

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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97817

Identifier Type: OTHER

Identifier Source: secondary_id

PEDSVAR0003

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-08123

Identifier Type: -

Identifier Source: org_study_id

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