Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies

This study is currently recruiting participants.
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01115777
First received: April 30, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric cancer survivor's functioning and quality of life. It has become tremendously important to assess the long-term complications due to therapy in this growing sector of survivors and to tailor our treatments so as to minimize these late effects.

The Investigators at MGH are committed to improving the delivery of radiotherapy to our patients and improving the outcome for these patients. MGH has an on-site cyclotron for proton radiotherapy in order to provide the most advanced care for patients in need. Proton therapy possesses a clinical advantage over standard photon therapy in that its optimal dose distribution delivers the bulk of radiation to the tumor site. This method spares the greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.

Through open pediatric protocols for patients treated with proton radiotherapy, the investigators aim to define and report the acute and late effects associated with treatment.

The investigators also treat a number of patients off-protocol with both proton and photon radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction with other clinical data that may be pertinent to the site of tumor treatment. This research is significant in that it will allow us to delineate the positive and negative effects of radiation treatment on patients' QOL, highlighting points of success and exposing areas that are in need of improvement. Such knowledge will be used to improve the experience of pediatric cancer survivors in the future.

The aims of this study are: 1) to prospectively collect and report the QOL outcomes in patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical information.


Condition Intervention
Brain Tumors
Non-CNS Malignancies
Other: Quality of Life surveys completed at specified timepoints

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-CNS Malignancies

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Assessment of Quality of Life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Longitudinal description of quality of life outcomes in patients treated with radiation therapy


Secondary Outcome Measures:
  • Correlation of QOL data with clinical information [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2005
Estimated Study Completion Date: March 2029
Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric patients treated with radiotherapy Other: Quality of Life surveys completed at specified timepoints
Quality of Life surveys (no treatment)

Detailed Description:

You will be asked to complete a series of questionnaires during your treatment and annually for ten years.

  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

Patients coming to MGH for radiation therapy with curative intent.

Criteria

Inclusion Criteria:

  • Any patient being treated with radiation therapy with curative intent
  • Patients between the ages of 2 and 25
  • Patients who speak either English or Spanish
  • Patients who agree to fill out the questionnaire

Exclusion Criteria:

  • Patients younger than 2 years of age or over 25
  • Patients receiving treatment with palliative intent
  • Patients who do not wish to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115777

Contacts
Contact: Torunn I Yock, MD 617-726-5184 TYOCK@PARTNERS.ORG

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Torunn I Yock, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01115777     History of Changes
Other Study ID Numbers: 2005P001629
Study First Received: April 30, 2010
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pediatric patients
treated with
radiation therapy
for brain tumors
and non-CNS malignancies

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

ClinicalTrials.gov processed this record on April 22, 2014