NCT05224297

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

January 25, 2022

Last Update Submit

November 19, 2024

Conditions

Keywords

radiation oncologypatient reported outcome

Outcome Measures

Primary Outcomes (1)

  • radiation-related side effects

    during radiotherapy and after (up until 5 years)

Study Arms (9)

breast

Radiation: external beam photon therapy

thorax

Radiation: external beam photon therapy

skin

Radiation: external beam photon therapy

abdomen

Radiation: external beam photon therapy

skull

Radiation: external beam photon therapy

head and neck

Radiation: external beam photon therapy

pelvis male

Radiation: external beam photon therapy

pelvis female

Radiation: external beam photon therapy

extremities

Radiation: external beam photon therapy

Interventions

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

abdomenbreastextremitieshead and neckpelvis femalepelvis maleskinskullthorax

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

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

Locations