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Patient Experience Data in Radiation Oncology (PEDRO)

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ClinicalTrials.gov Identifier: NCT05224297
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Gerd Heilemann, Medical University of Vienna

Study Description
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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.

Condition or disease Intervention/treatment
Radiotherapy Side Effect PROMs Radiation: external beam photon therapy

Study Design
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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Experience Data in Radiation Oncology
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025
Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. radiation-related side effects [ Time Frame: during radiotherapy and after (up until 5 years) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is aimed to include a comprehensive representative cross-section for each of the study groups.
Criteria

Inclusion Criteria:

  • all patients receiving external beam radiotherapy

Exclusion Criteria:

  • unable to independently answer questionnaires on radiation-induced side effects
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05224297


Contacts
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Contact: Gerd Heilemann, PhD 004314040072710 gerd.heilemann@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerd Heilemann, PhD         
Contact: Andreas Renner, PhD         
Sponsors and Collaborators
Medical University of Vienna
More Information
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Responsible Party: Gerd Heilemann, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT05224297    
Other Study ID Numbers: 2184/2019
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gerd Heilemann, Medical University of Vienna:
radiation oncology
patient reported outcome
Additional relevant MeSH terms:
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Neoplasms