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

Medical University Innsbruck

Status: Completed

Conditions: Cancer

Treatments: Other: CTCAE rating; Other: PRO data is displayed; Other: Patient-reported outcomes assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04066868

1020/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,013 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,013 participants in 2 patient groups

PRO active

Experimental group

Treatment:

Other: Patient-reported outcomes assessment

Other: PRO data is displayed

Other: CTCAE rating

PRO not active

Active Comparator group

Treatment:

Other: Patient-reported outcomes assessment

Other: CTCAE rating