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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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. MD Anderson Cancer Center, another facility with an onsite proton facility, will be collaborating with us on this portion of the study.
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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | March 2014 (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)
|
Eligibility| Ages Eligible for Study: | 2 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients coming to MGH or MD Anderson for radiation therapy with curative intent.
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| 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 |
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: | May 2, 2013 |
| 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 June 18, 2013