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

December 5, 2019 updated by: Torunn Yock, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients coming to MGH for radiation therapy with curative intent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric patients treated with radiotherapy
Other: Quality of Life surveys completed at specified timepoints
Quality of Life surveys (no treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Quality of Life
Time Frame: 10 years
Longitudinal description of quality of life outcomes in patients treated with radiation therapy
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of QOL data with clinical information
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Actual)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005P001629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Tumors

Clinical Trials on Quality of Life surveys completed at specified timepoints

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe