Clinical trial NCT04416672: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Neoplasms
Keywords: PRO-CTCAE
EORTC QLQ-C30 or Disease-Specific Questionnaire
HADS
PGIC Scale
Performance Status
Quality of Life
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 3675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any type of cancer

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 criteria: 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 the need 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 Criteria:

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

Primary outcomes:
measure: Validity of the italian version of the PRO-CTCAE
timeFrame: at baseline (up to 3weeks)
measure: Validity of the italian version of the PRO-CTCAE
timeFrame: at 3 weeks (up to 6 weeks)
measure: Responsiveness of the italian version of the PRO-CTCAE
timeFrame: at baseline (up to 3 weeks)
measure: Responsiveness of the italian version of the PRO-CTCAE
timeFrame: at 3 weeks (up to 6 weeks)
Secondary outcomes:
measure: Differences in psychometric measures according to tumor type and treatment
timeFrame: at 3 weeks (up to 6 weeks)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II
city: Brindisi
country: Italy
facility: U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliar
city: Genova
country: Italy
facility: Oncologia Medica 2 - IRCCS AOU San Martino
city: Lecce
country: Italy
facility: Oncologia - A.O. Cardinale G. Panico
city: Lecce
country: Italy
facility: Oncologia Medica - AO Vito Fazzi
city: Meldola
country: Italy
facility: Oncologia Medica, Istituto Romagnolo per lo Studio e la Cura dei Tumori
city: Messina
country: Italy
facility: A.O.Ospedali Riuniti Papardo Piemonte U.O.C. di Oncologia Medica
city: Milan
country: Italy
facility: Fondazione IRCCS, Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: Ginecologia e Ostetricia - IRCCS Ospedale San Raffaele
city: Milan
country: Italy
facility: Oncologia - ASST Rhodense - Presidio di Garbagnat
city: Milan
country: Italy
facility: Oncologia - ASST Rhodense - Presidio di Rho
city: Naples
country: Italy
facility: Istituto Nazionale Tumori, Dip. Uro-Ginecologico S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
city: Naples
country: Italy
facility: Oncologia Medica Toraco-Polmonare -Istituto Nazionale Tumori
city: Naples
country: Italy
facility: Servizio di Oncologia Medica ed Ematologia - DAI di Internistica Polispecialistica- AOU Università degli studi della Campania "Luigi Vanvitelli"
city: Naples
country: Italy
facility: Struttura semplice Sarcomi ossa e tessuti molli, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
city: Napoli
country: Italy
facility: U.O.C. di Oncologia - Presidio Monaldi - AORN Ospedale dei Colli
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Parma
country: Italy
facility: AOU Oncologia Medica
city: Pavia
country: Italy
facility: Oncologia traslazionale - ICS Maugeri di Pavia
city: Piacenza
country: Italy
facility: Oncologia Medica ed Ematologia, USL di Piacenza - Ospedale Guglielmo da Saliceto
city: Roma
country: Italy
facility: Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"
city: Roma
country: Italy
facility: UOC Oncologia Medica 1 - Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
city: Taranto
country: Italy
facility: Oncologia - Ospedale S. G. Moscati
city: Verona
country: Italy
facility: Oncologia Medica - Istituto Sacro Cuore Don Calabria
Study officials:
affiliation: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: Francesco Perrone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: