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Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066868
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Bezirkskrankenhaus Kufstein
Centre Hospitalier Universitaire de Besancon
Martin-Luther-Universität Halle-Wittenberg
Università di Cagliari
Kansai Medical University
Information provided by (Responsible Party):
Medical University Innsbruck

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 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.

Condition or disease Intervention/treatment Phase
Cancer Other: Patient-reported outcomes assessment Other: CTCAE rating Other: PRO data is displayed Not Applicable

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.

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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 : August 31, 2021
Estimated Study Completion Date : August 31, 2021

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




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Bernhard Holzner, Prof. PhD +43(0)50 504 24253 berhard.holzner@tirol-kliniken.at

Locations
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Austria
Bezirkskrankenhaus Kufstein Recruiting
Kufstein, Austria, 6330
Contact: August Zabernigg, MD       interne@bkh-kufstein.at   
Sponsors and Collaborators
Medical University Innsbruck
Bezirkskrankenhaus Kufstein
Centre Hospitalier Universitaire de Besancon
Martin-Luther-Universität Halle-Wittenberg
Università di Cagliari
Kansai Medical University
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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: February 21, 2020
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University Innsbruck:
patient-reported outcomes (PRO)
common terminology criteria for adverse events (CTCAE)
quality of life
electronic data assessment