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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066868
• Other study ID #: 1020/2019
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Medical University Innsbruck
• Contact: Bernhard Holzner, Prof. PhD
• Phone: +43(0)50 504 24253
• Email: berhard.holzner[@]tirol-kliniken.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1024
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Patient-reported outcomes assessment
Patient-reported outcomes are electronically assessed using EORTC QOL measures
• CTCAE rating
CTCAE Ratings are conducted by clinicians
• PRO data is displayed
PRO data is displayed right next to the CTCAE rating

Locations

Country	Name	City	State
Austria	Bezirkskrankenhaus Kufstein	Kufstein

Sponsors (11)

Lead Sponsor	Collaborator
Medical University Innsbruck	Bezirkskrankenhaus Kufstein, Centre Hospitalier Universitaire de Besancon, Clinical Hospital Center Rijeka, Kansai Medical University, King Hussein Cancer Center, King's College, Martin-Luther-Universität Halle-Wittenberg, Rigshospitalet, Denmark, Tata Memorial Hospital, Università di Cagliari

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library	patient-reported quality of life	single assessment of quality of life before the medical consultation
Primary	CTCAE V4.0	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
Primary	CTCAE V4.0	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