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
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|ClinicalTrials.gov Identifier: NCT01115777|
Recruitment Status : Recruiting
First Posted : May 4, 2010
Last Update Posted : September 2, 2016
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 or disease||Intervention/treatment|
|Brain Tumors Non-CNS Malignancies||Other: Quality of Life surveys completed at specified timepoints|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-CNS Malignancies|
|Study Start Date :||September 2005|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||March 2029|
|Pediatric patients treated with radiotherapy||
Other: Quality of Life surveys completed at specified timepoints
Quality of Life surveys (no treatment)
- Assessment of Quality of Life [ Time Frame: 10 years ]Longitudinal description of quality of life outcomes in patients treated with radiation therapy
- Correlation of QOL data with clinical information [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115777
|Contact: Torunn I Yock, MD||617-726-5184||TYOCK@PARTNERS.ORG|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Torunn I Yock, MD|
|Principal Investigator:||Torunn Yock, MD||Massachusetts General Hospital|