Clinical trial NCT04066868: Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
Official title: Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: patient-reported outcomes (PRO)
common terminology criteria for adverse events (CTCAE)
quality of life
electronic data assessment
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Bezirkskrankenhaus Kufstein
name: Centre Hospitalier Universitaire de Besancon
name: Martin-Luther-Universität Halle-Wittenberg
name: Università di Cagliari
name: Kansai Medical University
name: King Hussein Cancer Center
name: Tata Memorial Hospital
name: Rigshospitalet, Denmark
name: Clinical Hospital Center Rijeka
name: N.N. Blokhin National Medical Research Center of Oncology
First posted: 2019-08-26
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library
timeFrame: single assessment of quality of life before the medical consultation
measure: CTCAE V5.0
timeFrame: single assessment during the medical consultation with physician 1 on the same day of PRO assessment
measure: CTCAE V5.0
timeFrame: single assessment during the medical consultation with physician 2 on the same day of PRO assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Kufstein
country: Austria
facility: Bezirkskrankenhaus Kufstein
Study officials:
References:
citation: Wintner LM, Giesinger JM, Sztankay M, Bottomley A, Holzner B; EORTC Quality of Life Group. Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial. Trials. 2020 Oct 13;21(1):849. doi: 10.1186/s13063-020-04745-w.