CancerNCT04066868
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
A study testing Patient-reported outcomes assessment, CTCAE rating and PRO data is displayed in people with Cancer, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient-reported outcomes assessment, CTCAE rating and PRO data is displayed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,013 participants
- Where
- 1 siteAustria
- Study dates
- 10 Feb 2020to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- psychiatric diagnosis or mental health problems
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Patient-reported outcomes assessment, CTCAE rating, PRO data is displayed
- Keywords
- patient-reported outcomes (PRO), common terminology criteria for adverse events (CTCAE), quality of life, electronic data assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-reported outcomes assessmentOther
Patient-reported outcomes are electronically assessed using EORTC QOL measures
CTCAE ratingOther
CTCAE Ratings are conducted by clinicians
PRO data is displayedOther
PRO data is displayed right next to the CTCAE rating
| Study group | Role | What they receive |
|---|---|---|
| PRO active | Experimental | Not described Receives: Other: Patient-reported outcomes assessment; Other: CTCAE rating; Other: PRO data is displayed |
| PRO not active | Active comparator | Not described Receives: Other: Patient-reported outcomes assessment; Other: CTCAE rating |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library
patient-reported quality of life
Measured: 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)
Measured: 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)
Measured: single assessment during the medical consultation with physician 2 on the same day of PRO assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start10 Feb 2020
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Bezirkskrankenhaus Kufstein, Centre Hospitalier Universitaire de Besancon, Martin-Luther-Universität Halle-Wittenberg, Università di Cagliari, Kansai Medical University, King Hussein Cancer Center, Tata Memorial Hospital, Copenhagen University Hospital, Rigshospitalet, Clinical Hospital Center Rijeka, N.N. Blokhin National Medical Research Center of Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066868
- Sponsor's protocol ID
- 1020/2019
- Status last verified
- Apr 2025
- First submitted
- 19 Aug 2019
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41570841Wintner 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.
PubMed 33050917
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
- ClinicalTrials.gov ID
- NCT04066868
- Acronym / sponsor ID
- 1020/2019
- Conditions
- Cancer
- Keywords
- patient-reported outcomes (PRO), common terminology criteria for adverse events (CTCAE), quality of life, electronic data assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Bezirkskrankenhaus Kufstein, Centre Hospitalier Universitaire de Besancon, Martin-Luther-Universität Halle-Wittenberg, Università di Cagliari, Kansai Medical University, King Hussein Cancer Center, Tata Memorial Hospital, Copenhagen University Hospital, Rigshospitalet, Clinical Hospital Center Rijeka, N.N. Blokhin National Medical Research Center of Oncology
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO active | Experimental | Other: Patient-reported outcomes assessment, Other: CTCAE rating, Other: PRO data is displayed |
| PRO not active | Active comparator | Other: Patient-reported outcomes assessment, Other: CTCAE rating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- psychiatric diagnosis or mental health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-reported outcomes assessmentPatient-reported outcomes are electronically assessed using EORTC QOL measures | Other | PRO active, PRO not active |
| CTCAE ratingCTCAE Ratings are conducted by clinicians | Other | PRO active, PRO not active |
| PRO data is displayedPRO data is displayed right next to the CTCAE rating | Other | PRO active |
Primary outcome
EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library
Time frame: single assessment of quality of life before the medical consultation
patient-reported quality of life
CTCAE V5.0
Time frame: single assessment during the medical consultation with physician 1 on the same day of PRO assessment
physician 1 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)
CTCAE V5.0
Time frame: single assessment during the medical consultation with physician 2 on the same day of PRO assessment
physician 2 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Derived from this study: PubMed 41570841Wintner 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.
- Derived from this study: PubMed 33050917Wintner 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.
- Study protocol publicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-reported outcomes assessment, CTCAE rating and PRO data is displayed in people with Cancer, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library (time frame: single assessment of quality of life before the medical consultation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066868, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.