Clinical trial · Interventional
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
NCT04066868CI-TRIAL-00088731completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTCAE rating | Other | — | UNRESOLVED |
| Patient-reported outcomes assessment | Other | — | UNRESOLVED |
| PRO data is displayed | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PRO active
- interventionNames
- Other: Patient-reported outcomes assessment
- Other: CTCAE rating
- Other: PRO data is displayed
- type
- ACTIVE_COMPARATOR
- label
- PRO not active
- interventionNames
- Other: Patient-reported outcomes assessment
- Other: CTCAE rating
Primary outcomes (3)
- 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
- description
- patient-reported quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDWintner 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. PMID 41570841
- DERIVEDWintner 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. PMID 33050917