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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01115777
Recruitment Status : Active, not recruiting
First Posted : May 4, 2010
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date April 30, 2010
First Posted Date May 4, 2010
Last Update Posted Date December 6, 2019
Study Start Date September 2005
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2014)
Assessment of Quality of Life [ Time Frame: 10 years ]
Longitudinal description of quality of life outcomes in patients treated with radiation therapy
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01115777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 10, 2014)
Correlation of QOL data with clinical information [ Time Frame: 10 years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-CNS Malignancies
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.

Detailed Description You will be asked to complete a series of questionnaires during your treatment and annually thereafter.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients coming to MGH for radiation therapy with curative intent.
Condition
  • Brain Tumors
  • Non-CNS Malignancies
Intervention Other: Quality of Life surveys completed at specified timepoints
Quality of Life surveys (no treatment)
Study Groups/Cohorts Pediatric patients treated with radiotherapy
Intervention: Other: Quality of Life surveys completed at specified timepoints
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 10, 2014)
600
Original Estimated Enrollment
 (submitted: May 3, 2010)
500
Estimated Study Completion Date March 2029
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01115777
Other Study ID Numbers 2005P001629
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Torunn Yock, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2019