Patient Experience Data in Radiation Oncology (PEDRO)

February 23, 2022 updated by: Gerd Heilemann, Medical University of Vienna
The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on adverse effects during and after RT. This real-world evidence (RWE) database will be the basis to monitor and evaluate future technological developments, combination treatments (e.g. radioimmunotherapy, etc.), or changes in treatment protocols. The pseudonymized data will be linked to data in the oncological information system and dosimetric data from the treatment planning system. In this way, they represent a basic building block of patient-oriented development of clinical radiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

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

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Gerd Heilemann, PhD
        • Contact:
          • Andreas Renner, PhD

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

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study is aimed to include a comprehensive representative cross-section for each of the study groups.

Description

Inclusion Criteria:

  • all patients receiving external beam radiotherapy

Exclusion Criteria:

  • unable to independently answer questionnaires on radiation-induced side effects

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
breast
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
thorax
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
skin
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
abdomen
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
skull
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
head and neck
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
pelvis male
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
pelvis female
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).
extremities
Radiation: external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
radiation-related side effects
Time Frame: during radiotherapy and after (up until 5 years)
during radiotherapy and after (up until 5 years)

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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 (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2025

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (ACTUAL)

February 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2184/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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