- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066868
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bernhard Holzner, Prof. PhD
- Phone Number: +43(0)50 504 24253
- Email: berhard.holzner@tirol-kliniken.at
Study Locations
-
-
-
Kufstein, Austria, 6330
- Recruiting
- Bezirkskrankenhaus Kufstein
-
Contact:
- August Zabernigg, MD
- Email: interne@bkh-kufstein.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRO active
|
Patient-reported outcomes are electronically assessed using EORTC QOL measures
CTCAE Ratings are conducted by clinicians
PRO data is displayed right next to the CTCAE rating
|
Active Comparator: PRO not active
|
Patient-reported outcomes are electronically assessed using EORTC QOL measures
CTCAE Ratings are conducted by clinicians
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
single assessment of quality of life before the medical consultation
|
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)
|
single assessment during the medical consultation with physician 1 on the same day of PRO assessment
|
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)
|
single assessment during the medical consultation with physician 2 on the same day of PRO assessment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1020/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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