JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04066868

Studienbeginn:
Februar 2020

Letztes Update:
23.10.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University Innsbruck

Collaborator:
Bezirkskrankenhaus Kufstein, Centre Hospitalier Universitaire de Besancon, Martin-Luther-Universität Halle-Wittenberg, Università di Cagliari, Kansai Medical University, King Hussein Cancer Center, Tata Memorial Hospital, Rigshospitalet, Denmark, King's College, C

Kontakt

Bernhard Holzner, Prof. PhD
Kontakt:
Phone: +43(0)50 504 24253
E-Mail: berhard.holzner@tirol-kliniken.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Bezirkskrankenhaus Kufstein
6330 Kufstein
AustriaRekrutierend» Google-Maps
Ansprechpartner:
August Zabernigg, MD
E-Mail: interne@bkh-kufstein.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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)

Studien-Arme

Experimental: PRO active
Active Comparator: PRO not active

Geprüfte Regime

Patient-reported outcomes assessment:
Patient-reported outcomes are electronically assessed using EORTC QOL measures
CTCAE rating:
CTCAE Ratings are conducted by clinicians
PRO data is displayed:
PRO data is displayed right next to the CTCAE rating

Quelle: ClinicalTrials.gov

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