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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Other: Patient-reported outcomes assessment
* Other: CTCAE rating
* Other: PRO data is displayed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO active<br> | Other: Patient-reported outcomes assessment<br>* Patient-reported outcomes are electronically assessed using EORTC QOL measures<br>Other: CTCAE rating<br>* CTCAE Ratings are conducted by clinicians<br>Other: PRO data is displayed<br>* PRO data is displayed right next to the CTCAE rating<br>|
| Active Comparator: PRO not active<br> | Other: Patient-reported outcomes assessment<br>* Patient-reported outcomes are electronically assessed using EORTC QOL measures<br>Other: CTCAE rating<br>* CTCAE Ratings are conducted by clinicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library | patient-reported quality of life | single assessment of quality of life before the medical consultation | 
| CTCAE V4.0 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, patient-reported outcomes (PRO), common terminology criteria for adverse events (CTCAE), electronic data assessment