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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Patient-reported outcomes assessment; Other: CTCAE rating; Other: PRO data is displayed

• Registration Number: NCT04066868
• Lead Sponsor: Medical University Innsbruck

Brief 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.

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 Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2020-02-10
• Primary Completion: 2024-12-06
• Study Completion: 2024-12-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1013

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRO not active	Patient-reported outcomes assessment	-
PRO active	Patient-reported outcomes assessment	-
PRO active	PRO data is displayed	-
PRO active	CTCAE rating	-
PRO not active	CTCAE rating	-

Primary Outcome Measures

Name	Time	Method
EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library	single assessment of quality of life before the medical consultation	patient-reported quality of life
CTCAE V5.0	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)

Trial Locations

Locations (1)

Bezirkskrankenhaus Kufstein; 🇦🇹 Kufstein, Austria