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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
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

August 11, 2010
April 18, 2012
October 2009
March 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01180881 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pediatric patients who received proton radiation therapy at MGH

  • Brain Tumor
  • Central Nervous System Neoplasms
Not Provided
Proton Radiation Patients at MGH
Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
2 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180881
2009A058394
Yes
Margaret Pulsifer, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Margaret B. Pulsifer, PhD Massachusetts General Hospital
Massachusetts General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP