Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
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| ClinicalTrials.gov Identifier: NCT04066868 |
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Recruitment Status :
Recruiting
First Posted : August 26, 2019
Last Update Posted : April 6, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Other: Patient-reported outcomes assessment Other: CTCAE rating Other: PRO data is displayed | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1024 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings |
| Actual Study Start Date : | February 10, 2020 |
| Estimated Primary Completion Date : | March 31, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: PRO active |
Other: Patient-reported outcomes assessment
Patient-reported outcomes are electronically assessed using EORTC QOL measures Other: CTCAE rating CTCAE Ratings are conducted by clinicians Other: PRO data is displayed PRO data is displayed right next to the CTCAE rating |
| Active Comparator: PRO not active |
Other: Patient-reported outcomes assessment
Patient-reported outcomes are electronically assessed using EORTC QOL measures Other: CTCAE rating CTCAE Ratings are conducted by clinicians |
- 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 V4.0 [ 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 V4.0 [ 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066868
| Contact: Bernhard Holzner, Prof. PhD | +43(0)50 504 24253 | berhard.holzner@tirol-kliniken.at |
| Austria | |
| Bezirkskrankenhaus Kufstein | Recruiting |
| Kufstein, Austria, 6330 | |
| Contact: August Zabernigg, MD interne@bkh-kufstein.at | |
| Responsible Party: | Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT04066868 |
| Other Study ID Numbers: |
1020/2019 |
| First Posted: | August 26, 2019 Key Record Dates |
| Last Update Posted: | April 6, 2022 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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patient-reported outcomes (PRO) common terminology criteria for adverse events (CTCAE) quality of life electronic data assessment |