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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01180881
• Other study ID #: 2009A058394
• Status: Active, not recruiting
• Start date: October 2009
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 25 Years

Eligibility

Inclusion Criteria:

1. Children diagnosed with brain or CNS tumors and treated with proton radiation therapy at the MGH Francis H. Burr Proton Center since September 2002

2. Patients received baseline neurocognitive testing at MGH

3. Patients =25 years at the time of diagnosis

4. Tumor location in the brain or CNS

5. Radiation treatment consisted of only proton radiotherapy

6. No prior radiation exposure or chemotherapy

Exclusion Criteria:

1. Patients receiving treatment with palliative intent

2. Patients who do not wish to participate

3. Patient is deceased at =1 year follow-up

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory of Executive Functioning	Questionnaire of executive functioning in children and young adults	Approximately one year post proton radiation treatment
Primary	Behavior Assessment System for Children	Questionnaire of behavioral functioning in children and young adults	Approximately one year following proton radiation treatment
Primary	Scales of Independent Behavior-Revised	Questionnaire of adaptive skills in children and young adults	Approximately one year following proton beam radiation therapy