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

Brain Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01115777
• Other study ID #: 2005P001629
• Status: Active, not recruiting
• Start date: September 2005
• Est. completion date: March 2029

Study information

• Verified date: December 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: March 2029
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Neoplasms
• Non-CNS Malignancies

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Quality of Life	Longitudinal description of quality of life outcomes in patients treated with radiation therapy	10 years
Secondary	Correlation of QOL data with clinical information		10 years