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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01180881
Enrollment
155
Registered
2010-08-12
Start date
2009-10-31
Completion date
2018-01-01
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Central Nervous System Neoplasms

Keywords

Proton Radiation, CNS tumors, Brain Tumors, Neurobehavioral functioning

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.

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Behavior Rating Inventory of Executive FunctioningApproximately one year post proton radiation treatmentQuestionnaire of executive functioning in children and young adults
Behavior Assessment System for ChildrenApproximately one year following proton radiation treatmentQuestionnaire of behavioral functioning in children and young adults
Scales of Independent Behavior-RevisedApproximately one year following proton beam radiation therapyQuestionnaire of adaptive skills in children and young adults

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026