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

Last updated: October 18, 2023
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

PRO data is displayed

Patient-reported outcomes assessment

CTCAE rating

Clinical Study ID

NCT04066868
1020/2019
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 1024
Treatment Group(s): 3
Primary Treatment: PRO data is displayed
Phase:
Study Start date:
February 10, 2020
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Bezirkskrankenhaus Kufstein

    Kufstein, 6330
    Austria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.