Patient Experience Data in Radiation Oncology
PEDRO
1 other identifier
observational
6,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedNovember 22, 2024
November 1, 2024
4.3 years
January 25, 2022
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
radiation-related side effects
during radiotherapy and after (up until 5 years)
Study Arms (9)
breast
thorax
skin
abdomen
skull
head and neck
pelvis male
pelvis female
extremities
Interventions
Patients receive external beam photon therapy for different tumor locations (groups).
Eligibility Criteria
The study is aimed to include a comprehensive representative cross-section for each of the study groups.
You may qualify if:
- all patients receiving external beam radiotherapy
You may not qualify if:
- unable to independently answer questionnaires on radiation-induced side effects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 25, 2022
First Posted
February 4, 2022
Study Start
October 1, 2020
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share