Assessment and Rehabilitation of Cognitive Impairments in... | NCT00490334

Studies
Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

NCT00490334

Sponsor

Stanford University

Status

Completed

Last Update Posted

May 21, 2015Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Neoplasms

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
97817	Other Identifier	Stanford University Alternate IRB Approval Number
PEDSVAR0003	Other Identifier	OnCore

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jun 20, 2007

First Submission Date that Met QC Criteria

Jun 20, 2007

First Posted Date

Jun 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2015

Last Update Posted Date

May 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

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

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Shelli Kesler	Stanford University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D002277	Carcinoma
D000230	Adenocarcinoma
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D007945	Leukemia, Lymphoid
D007938	Leukemia

Browse Leaves

Not provided

Browse Branches

Not provided