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Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings

NCT04066868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1013

Last updated 2025-04-20

No results posted yet for this study

Summary

This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is to demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.

Conditions

Interventions

OTHER

Patient-reported outcomes assessment

Patient-reported outcomes are electronically assessed using EORTC QOL measures

OTHER

CTCAE rating

CTCAE Ratings are conducted by clinicians

OTHER

PRO data is displayed

PRO data is displayed right next to the CTCAE rating

Sponsors & Collaborators

  • Bezirkskrankenhaus Kufstein

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Besancon

    collaborator OTHER

  • Martin-Luther-Universität Halle-Wittenberg

    collaborator OTHER

  • Università di Cagliari

    collaborator UNKNOWN

  • Kansai Medical University

    collaborator OTHER

  • King Hussein Cancer Center

    collaborator OTHER

  • Tata Memorial Hospital

    collaborator OTHER_GOV

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Clinical Hospital Center Rijeka

    collaborator OTHER

  • N.N. Blokhin National Medical Research Center of Oncology

    collaborator OTHER

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066868 on ClinicalTrials.gov