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