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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Margaret Pulsifer, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01180881
First received: August 11, 2010
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Brain Tumor
Central Nervous System Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Behavior Rating Inventory of Executive Functioning [ Time Frame: Approximately one year post proton radiation treatment ] [ Designated as safety issue: No ]
    Questionnaire of executive functioning in children and young adults

  • Behavior Assessment System for Children [ Time Frame: Approximately one year following proton radiation treatment ] [ Designated as safety issue: No ]
    Questionnaire of behavioral functioning in children and young adults

  • Scales of Independent Behavior-Revised [ Time Frame: Approximately one year following proton beam radiation therapy ] [ Designated as safety issue: No ]
    Questionnaire of adaptive skills in children and young adults


Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Proton Radiation Patients at MGH
Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy

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

Ages Eligible for Study:   2 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients who received proton radiation therapy at MGH

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180881

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Margaret B. Pulsifer, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Margaret Pulsifer, Neuropsychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01180881     History of Changes
Other Study ID Numbers: 2009A058394
Study First Received: August 11, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Proton Radiation
CNS tumors
Brain Tumors
Neurobehavioral functioning

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 13, 2013