Status:
COMPLETED
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Bezirkskrankenhaus Kufstein
Centre Hospitalier Universitaire de Besancon
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. The primary obje...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
1013 Patients enrolled
Trial Details
Trial ID
NCT04066868
Start Date
February 10 2020
End Date
December 6 2024
Last Update
April 20 2025
Active Locations (1)
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1
Bezirkskrankenhaus Kufstein
Kufstein, Austria, 6330