Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Behavior Assessment System for Children
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients receiving treatment with palliative intent
- •Patients who do not wish to participate
- •Patient is deceased at ≥1 year follow-up
结局指标
主要结局
Behavior Assessment System for Children
时间窗: Approximately one year following proton radiation treatment
Questionnaire of behavioral functioning in children and young adults
Behavior Rating Inventory of Executive Functioning
时间窗: Approximately one year post proton radiation treatment
Questionnaire of executive functioning in children and young adults
Scales of Independent Behavior-Revised
时间窗: Approximately one year following proton beam radiation therapy
Questionnaire of adaptive skills in children and young adults
次要结局
未报告次要终点
研究者
Margaret Pulsifer
Neuropsychologist
Massachusetts General Hospital