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

April 16, 2025 updated by: Medical University Innsbruck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In oncology, detection and tracking of adverse events (AEs) are a top priority in both clinical trials and routine care. The classification of AEs mostly relies on the Common Toxicity Terminology for Adverse Events (CTCAE) developed by the US-American National Institutes of Health and the National Cancer Institute.

It is known, however, that the assessment of AEs can greatly vary depending on whether they are assessed by patients or by clinicians.

Procedure: The patients (any oncological diagnosis, day clinic or inpatient for treatment with chemotherapy or immunotherapy; open 1:1 randomized) fill out an EORTC quality of life questionnaire electronically (C30 + further questions). These PRO data are immediately available for the clinicians. Independently of each other, two different clinicians conduct a medical consultation with the patient and electronically a CTCAE rating. For the intervention Group, clinicians see the PRO values directly next to the input options for the CTCAE rating. For the control Group, clinicians see the input options for the CTCAE rating. The similarity of the assessments is checked using intra-class correlation.

The combined use of PROs and CTCAE data makes particular sense for AEs/aspects that are directly experienced by the patient (fatigue, pain, cognitive problems, emotional functioning, ...) and can only be adequately recorded by the clinician through communication with the patient.

Study Type

Interventional

Enrollment (Actual)

1013

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Kufstein, Austria, 6330
        • Bezirkskrankenhaus Kufstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • any Cancer diagnosis
  • current treatment with chemotherapy or immunotherapy
  • symptom burden equal or greater score 3 of the screening question "On a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week?"
  • ability to understand the questions linguistically and cognitively
  • written informed consent

Exclusion Criterion:

  • psychiatric diagnosis or mental health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRO active
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
Active Comparator: PRO not active
Other: Patient-reported outcomes assessment
Patient-reported outcomes are electronically assessed using EORTC QOL measures
Other: CTCAE rating
CTCAE Ratings are conducted by clinicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library
Time Frame: single assessment of quality of life before the medical consultation
patient-reported quality of life
single assessment of quality of life before the medical consultation
CTCAE V5.0
Time Frame: single assessment during the medical consultation with physician 1 on the same day of PRO assessment
physician 1 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)
single assessment during the medical consultation with physician 1 on the same day of PRO assessment
CTCAE V5.0
Time Frame: single assessment during the medical consultation with physician 2 on the same day of PRO assessment
physician 2 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)
single assessment during the medical consultation with physician 2 on the same day of PRO assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Collaborators

Rigshospitalet, Denmark
Centre Hospitalier Universitaire de Besancon
Martin-Luther-Universität Halle-Wittenberg
Tata Memorial Hospital
King Hussein Cancer Center
Clinical Hospital Center Rijeka
Kansai Medical University
Bezirkskrankenhaus Kufstein
Università di Cagliari
N.N. Blokhin National Medical Research Center of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Actual)

December 6, 2024

Study Completion (Actual)

December 6, 2024

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1020/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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