Validation of the Italian Version of the PRO-CTCAE

Last updated: March 23, 2023
Sponsor: National Cancer Institute, Naples
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT04416672
VIP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of any type of cancer •≥18 years of age.
  • Female or male
  • With at least two planned clinic visits (a return visit within 3-6 weeks) to avoid theneed of extra visits
  • Actively receiving treatment for cancer (going to receive the second or further cycle)
  • Any ECOG performance status (PS)
  • Able to complete questionnaire by themselves or with assistance, by using a tablet
  • Able to speak and understand Italian
  • Providing informed written consent

Exclusion

Exclusion Criteria:

  • Having any kind of psychiatric disorder or major cognitive dysfunction hampering theprovision of informed consent.
  • Having received more than 5lines of therapies
  • Currently participating in other trials which imply the completion of Patient ReportedOutcomes (PROs) in the same period
  • Other important acute medical conditions.

Study Design

Total Participants: 3675
Study Start date:
July 01, 2018
Estimated Completion Date:
July 31, 2024

Study 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

Connect with a study center

  • Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II

    Bari,
    Italy

    Active - Recruiting

  • U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino

    Brindisi,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Cagliar

    Cagliari,
    Italy

    Active - Recruiting

  • Oncologia Medica 2 - IRCCS AOU San Martino

    Genova,
    Italy

    Active - Recruiting

  • Oncologia - A.O. Cardinale G. Panico

    Lecce,
    Italy

    Active - Recruiting

  • Oncologia Medica - AO Vito Fazzi

    Lecce,
    Italy

    Active - Recruiting

  • Oncologia Medica, Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola,
    Italy

    Active - Recruiting

  • A.O.Ospedali Riuniti Papardo Piemonte U.O.C. di Oncologia Medica

    Messina,
    Italy

    Active - Recruiting

  • Fondazione IRCCS, Istituto Nazionale dei Tumori

    Milan,
    Italy

    Active - Recruiting

  • Ginecologia e Ostetricia - IRCCS Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Oncologia - ASST Rhodense - Presidio di Garbagnat

    Milan,
    Italy

    Active - Recruiting

  • Oncologia - ASST Rhodense - Presidio di Rho

    Milan,
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori, Dip. Uro-Ginecologico S.C. Oncologia Clinica Sperimentale Uro-Ginecologica

    Naples,
    Italy

    Active - Recruiting

  • Oncologia Medica Toraco-Polmonare -Istituto Nazionale Tumori

    Naples,
    Italy

    Active - Recruiting

  • Servizio di Oncologia Medica ed Ematologia - DAI di Internistica Polispecialistica- AOU Università degli studi della Campania "Luigi Vanvitelli"

    Naples,
    Italy

    Active - Recruiting

  • Struttura semplice Sarcomi ossa e tessuti molli, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

    Naples,
    Italy

    Active - Recruiting

  • U.O.C. di Oncologia - Presidio Monaldi - AORN Ospedale dei Colli

    Napoli,
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto

    Padova,
    Italy

    Active - Recruiting

  • AOU Oncologia Medica

    Parma,
    Italy

    Active - Recruiting

  • Oncologia traslazionale - ICS Maugeri di Pavia

    Pavia,
    Italy

    Active - Recruiting

  • Oncologia Medica ed Ematologia, USL di Piacenza - Ospedale Guglielmo da Saliceto

    Piacenza,
    Italy

    Active - Recruiting

  • Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"

    Roma,
    Italy

    Active - Recruiting

  • UOC Oncologia Medica 1 - Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena

    Roma,
    Italy

    Active - Recruiting

  • Oncologia - Ospedale S. G. Moscati

    Taranto,
    Italy

    Active - Recruiting

  • Oncologia Medica - Istituto Sacro Cuore Don Calabria

    Verona,
    Italy

    Active - Recruiting

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