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| Name | Class |
|---|---|
| Bezirkskrankenhaus Kufstein | UNKNOWN |
| Centre Hospitalier Universitaire de Besancon | OTHER |
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
| Università di Cagliari |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO active | Experimental |
| |
| PRO not active | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-reported outcomes assessment | Other | Patient-reported outcomes are electronically assessed using EORTC QOL measures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| CTCAE V5.0 | 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 |
| CTCAE V5.0 | 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 |
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Inclusion Criteria:
Exclusion Criterion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezirkskrankenhaus Kufstein | Kufstein | 6330 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41570841 | Derived | Wintner LM, Sztankay M, Abdel-Razeq H, Hamdan-Mansour R, Caocci G, Mouillet G, Kikawa Y, Shibata N, Krishnamurthy MN, Joshi A, Krishnatry R, Jain A, Pappot H, Petranovic D, Trobentar A, Schmidt H, Schulze S, Tararykova A, Zabernigg A, Giesinger JM, Holzner B; EORTC Quality of Life Group. Inter-rater reliability of CTCAE assessments with or without EORTC patient-reported outcome data in a mixed cancer population: a multinational, open-label, randomised controlled trial. Lancet Oncol. 2026 Feb;27(2):233-242. doi: 10.1016/S1470-2045(25)00679-5. Epub 2026 Jan 19. | |
| 33050917 |
| Label | URL |
|---|---|
| Study protocol publication | View source |
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| UNKNOWN |
| Kansai Medical University | OTHER |
| King Hussein Cancer Center | OTHER |
| Tata Memorial Hospital | OTHER_GOV |
| Rigshospitalet, Denmark | OTHER |
| Clinical Hospital Center Rijeka | OTHER |
| N.N. Blokhin National Medical Research Center of Oncology | OTHER |
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| CTCAE rating | Other | CTCAE Ratings are conducted by clinicians |
|
| PRO data is displayed | Other | PRO data is displayed right next to the CTCAE rating |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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