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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01115777
Collaborator
(none)
600
1
282
2.1

Study Details

Study Description

Brief Summary

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 Phase
  • Other: Quality of Life surveys completed at specified timepoints

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
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
Study Start Date :
Sep 1, 2005
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Mar 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Pediatric patients treated with radiotherapy

Other: Quality of Life surveys completed at specified timepoints
Quality of Life surveys (no treatment)

Outcome Measures

Primary Outcome Measures

  1. Assessment of Quality of Life [10 years]

    Longitudinal description of quality of life outcomes in patients treated with radiation therapy

Secondary Outcome Measures

  1. Correlation of QOL data with clinical information [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Torunn Yock, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01115777
Other Study ID Numbers:
  • 2005P001629
First Posted:
May 4, 2010
Last Update Posted:
Dec 6, 2019
Last Verified:
Dec 1, 2019
Keywords provided by Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2019