NCT00945828

Brief Summary

Neurodevelopmental outcomes in children treated for cancer involving the central nervous system (CNS) provide educators with new challenges with regards to classification, monitoring, and intervention in the regular or special education classroom setting. Recommendations resulting from serial neurodevelopmental evaluations for these children often do not overlap with traditional special education recommendations commonly included in Individual Education Plans (IEPs) for children with congenital or genetic learning problems. The investigators currently do not know whether or not school-based treatment for learning problems, based on the child's IEP, incorporates recommendations made based on a neurodevelopmental evaluation appropriately. In addition, it is not clear whether or not the recommendations that are included in a child's IEP have any beneficial outcome on the child's learning and academic achievement over time. The purpose of this project is to examine the relationship between neurodevelopmental outcomes, recommendations for intervention, special education services and accommodations included in a child's school IEP, and outcome for the child following implementation of the IEP. The study has two major specific aims:

  1. 1.To quantify the clinical and educational contributions of recommendations resulting from neurodevelopmental evaluations and the subsequent development of IEPs.
  2. 2.To evaluate an intervention that will improve academic outcomes for children treated for cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

7.8 years

First QC Date

July 22, 2009

Last Update Submit

March 6, 2012

Conditions

Keywords

pediatric cancer, neurocognitive outcomes for pediatric canceracute lymphoblastic leukemiacentral nervous system tumorslymphoma

Outcome Measures

Primary Outcomes (1)

  • Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition

    Measured at Year 1, Year 2 and 3

Study Arms (2)

Annual Monitoring of IEP

EXPERIMENTAL

Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study.

Behavioral: Annual Intervention Group

Quarterly Monitoring of IEP

EXPERIMENTAL

Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study.

Behavioral: Quarterly Monitoring of IEP

Interventions

Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed.

Annual Monitoring of IEP

Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed.

Quarterly Monitoring of IEP

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children, ages 6-12 years, who are within 2-5 years of diagnosis for either central nervous system tumor or acute lymphocytic leukemia, or lymphoma at time of enrollment

You may not qualify if:

  • Children who have been diagnosed with any type of cancer other than a central nervous system tumor, lymphoma, or leukemia.
  • Children who are not between the ages of 6-12 years and who were not diagnosed within the past 2-5 years with central nervous system tumor, lymphoma, or leukemia.
  • Children who are monolingual in a language other than English or Spanish
  • Parent or caregiver of the child is not fluent in English or Spanish
  • Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mailman Center for Child Development University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaCentral Nervous System NeoplasmsLymphomaNeoplasms

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Officials

  • Daniel Armstrong, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR
  • Maria L Goldman, PsyD

    University of Miami

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

January 1, 2003

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations