Neurobehavioral Functioning in Pediatric Brain Tumor Patients After Proton Beam Radiation Treatment

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01180881

Collaborator

(none)

155

Enrollment

Location

164

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to follow up with all of the pediatric brain tumor patients who received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which there is baseline neuropsychological testing in order to measure changes, if any, in neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive abilities) and their use of special education services at one year or more post-treatment. The investigators will also correlate neurobehavioral data with pertinent clinical information. Participation will be maximized through the use of mail-in, parental- and self-report questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Central Nervous System Neoplasms

Detailed Description

The purpose of this study is to longitudinally examine neurobehavioral functioning outcomes and use of special education services in brain tumor and CNS tumor patients treated with proton radiation at MGH. Furthermore, we seek to correlate neurobehavioral data with pertinent clinical information. We anticipate better neurobehavioral functioning to be associated with use of protons (vs. photons, as reported in the literature). We also anticipate the need and utilization of special education services to be lower in brain and CNS tumor patients treated with protons (vs. photons, as reported in the literature). Lastly, we anticipate greater neurobehavioral deficits in patients whose proton radiation treatment involved the craniospinal axis compared to those who received proton radiation to the involved field.

Study Design

Study Type:

Observational

Actual Enrollment :

155 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Proton Radiation Patients at MGH Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy

Outcome Measures

Primary Outcome Measures

Behavior Rating Inventory of Executive Functioning [Approximately one year post proton radiation treatment]
Questionnaire of executive functioning in children and young adults
Behavior Assessment System for Children [Approximately one year following proton radiation treatment]
Questionnaire of behavioral functioning in children and young adults
Scales of Independent Behavior-Revised [Approximately one year following proton beam radiation therapy]
Questionnaire of adaptive skills in children and young adults

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children diagnosed with brain or CNS tumors and treated with proton radiation therapy at the MGH Francis H. Burr Proton Center since September 2002
Patients received baseline neurocognitive testing at MGH
Patients ≤25 years at the time of diagnosis
Tumor location in the brain or CNS
Radiation treatment consisted of only proton radiotherapy
No prior radiation exposure or chemotherapy