Spots Global Cancer Trial Database for Validation of the Italian Version of the PRO-CTCAE
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Validation of the Italian Version of the PRO-CTCAE
Official Title: VIP: Validation of the Italian Version of the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Prospective Multicenter Observational Study on Different Cancer Types
Study ID: NCT04416672
Conditions
Interventions
Study Description
Brief 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.
Detailed 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II, Bari, , Italy
U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino, Brindisi, , Italy
Azienda Ospedaliero Universitaria di Cagliar, Cagliari, , Italy
Oncologia Medica 2 - IRCCS AOU San Martino, Genova, , Italy
Oncologia - A.O. Cardinale G. Panico, Lecce, , Italy
Oncologia Medica - AO Vito Fazzi, Lecce, , Italy
Oncologia Medica, Istituto Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
A.O.Ospedali Riuniti Papardo Piemonte U.O.C. di Oncologia Medica, Messina, , Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, , Italy
Ginecologia e Ostetricia - IRCCS Ospedale San Raffaele, Milan, , Italy
Oncologia - ASST Rhodense - Presidio di Garbagnat, Milan, , Italy
Oncologia - ASST Rhodense - Presidio di Rho, Milan, , Italy
Istituto Nazionale Tumori, Dip. Uro-Ginecologico S.C. Oncologia Clinica Sperimentale Uro-Ginecologica, Naples, , Italy
Oncologia Medica Toraco-Polmonare -Istituto Nazionale Tumori, Naples, , Italy
Servizio di Oncologia Medica ed Ematologia - DAI di Internistica Polispecialistica- AOU Università degli studi della Campania "Luigi Vanvitelli", Naples, , Italy
Struttura semplice Sarcomi ossa e tessuti molli, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, , Italy
U.O.C. di Oncologia - Presidio Monaldi - AORN Ospedale dei Colli, Napoli, , Italy
Istituto Oncologico Veneto, Padova, , Italy
AOU Oncologia Medica, Parma, , Italy
Oncologia traslazionale - ICS Maugeri di Pavia, Pavia, , Italy
Oncologia Medica ed Ematologia, USL di Piacenza - Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena", Roma, , Italy
UOC Oncologia Medica 1 - Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Oncologia - Ospedale S. G. Moscati, Taranto, , Italy
Oncologia Medica - Istituto Sacro Cuore Don Calabria, Verona, , Italy
Contact Details
Name: Francesco Perrone, MD, PhD
Affiliation: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
