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NCT05224297 Clinical Trial

Patient Experience Data in Radiation Oncology

Radiotherapy Side Effect Clinical Trial

— PEDRO  

Official title:
Patient Experience Data in Radiation Oncology

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05224297
Other study ID # 2184/2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date January 1, 2025

Study information
Verified date February 2022
Source Medical University of Vienna
Contact Gerd Heilemann, PhD
Phone 004314040072710
Email gerd.heilemann@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 6000
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - all patients receiving external beam radiotherapy Exclusion Criteria: - unable to independently answer questionnaires on radiation-induced side effects

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• external beam photon therapy
Patients receive external beam photon therapy for different tumor locations (groups).

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary radiation-related side effects during radiotherapy and after (up until 5 years)
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