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

NCT01115777 | Active Not Recruiting

• 1 other identifier: 2005P001629
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumors; Non-CNS Malignancies

Keywords

Pediatric patients; treated with; radiation therapy; for brain tumors; and non-CNS malignancies

Outcome Measures

Primary Outcomes (1)

• Assessment of Quality of Life

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

  10 years

Secondary Outcomes (1)

• Correlation of QOL data with clinical information

  10 years

Study Arms (1)

Pediatric patients treated with radiotherapy

Other: Quality of Life surveys completed at specified timepoints

Interventions

Quality of Life surveys completed at specified timepoints OTHER

Quality of Life surveys (no treatment)

Pediatric patients treated with radiotherapy

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients coming to MGH for radiation therapy with curative intent.

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 2 years of age or over 25
• Patients receiving treatment with palliative intent
• Patients who do not wish to participate

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Torunn Yock, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Radiation Oncology

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: September 1, 2005
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)