Validation of the Italian Version of the PRO-CTCAE

Status Recruiting

Clinical Trial Summary

The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.

Clinical Trial Description

This is a prospective observational study, conducted in Italian cancer centers located Nationwide. The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting". The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties: - EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available. - the Hospital Anxiety and Depression Scale (HADS) - The Patients' Global Impression of Change (PGIC) Scale ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04416672
Study type	Observational
Source	National Cancer Institute, Naples
Contact	Francesco Perrone, MD, PhD
Phone	+390815903571
Email	f.perrone@istitutotumori.na.it
Status	Recruiting
Phase
Start date	July 1, 2018
Completion date	July 2024

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