Clinical trial NCT01180881: Neurobehavioral Functioning in Pediatric Brain Tumor Patients After Proton Beam Radiation Treatment
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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Tumor
Central Nervous System Neoplasms
Keywords: Proton Radiation
CNS tumors
Brain Tumors
Neurobehavioral functioning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 155
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who received proton radiation therapy at MGH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavior Rating Inventory of Executive Functioning
timeFrame: Approximately one year post proton radiation treatment
measure: Behavior Assessment System for Children
timeFrame: Approximately one year following proton radiation treatment
measure: Scales of Independent Behavior-Revised
timeFrame: Approximately one year following proton beam radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margaret B. Pulsifer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grieco JA, Evans CL, Yock TI, Pulsifer MB. Psychosocial and executive functioning late effects in pediatric brain tumor survivors after proton radiation. Childs Nerv Syst. 2024 Nov;40(11):3553-3561. doi: 10.1007/s00381-024-06579-2. Epub 2024 Sep 2.
citation: Pulsifer MB, Duncanson H, Grieco J, Evans C, Tseretopoulos ID, MacDonald S, Tarbell NJ, Yock TI. Cognitive and Adaptive Outcomes After Proton Radiation for Pediatric Patients With Brain Tumors. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):391-398. doi: 10.1016/j.ijrobp.2018.05.069. Epub 2018 Jun 6.