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

NCT01180881 | Completed DMC

• 1 other identifier: 2009A058394
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Central Nervous System Neoplasms

Keywords

Proton Radiation; CNS tumors; Brain Tumors; Neurobehavioral functioning

Outcome Measures

Primary Outcomes (3)

• Behavior Rating Inventory of Executive Functioning

  Questionnaire of executive functioning in children and young adults

  Approximately one year post proton radiation treatment

• Behavior Assessment System for Children

  Questionnaire of behavioral functioning in children and young adults

  Approximately one year following proton radiation treatment

• Scales of Independent Behavior-Revised

  Questionnaire of adaptive skills in children and young adults

  Approximately one year following proton beam radiation therapy

Study Arms (1)

Proton Radiation Patients at MGH

Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who received proton radiation therapy at MGH

You may qualify if:

• 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

You may not qualify if:

• Patients receiving treatment with palliative intent
• Patients who do not wish to participate
• Patient is deceased at ≥1 year follow-up

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 39222091 RESULT

• 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.

  PMID: 30108004 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Margaret B. Pulsifer, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 12, 2010
• Study Start: October 1, 2009
• Primary Completion: December 31, 2017
• Study Completion: January 1, 2018
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)