Validation of the Italian Version of the PRO-CTCAE
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
1 other identifier
observational
3,675
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedMarch 24, 2023
March 1, 2023
6 years
May 29, 2020
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Validity of the italian version of the PRO-CTCAE
Evaluation of the validity (degree to which an instrument accurately measures the underlying phenomenon) of single items of the PRO-CTCAE, Italian version, for each of the type of cancer considered
at baseline (up to 3weeks)
Validity of the italian version of the PRO-CTCAE
Evaluation of the validity (degree to which an instrument accurately measures the underlying phenomenon) of single items of the PRO-CTCAE, Italian version, for each of the type of cancer considered
at 3 weeks (up to 6 weeks)
Responsiveness of the italian version of the PRO-CTCAE
Evaluation of responsiveness (ability of an instrument to show a change when there has been a change in the phenomenon) of single items of the PRO-CTCAE for each of the types of cancer considered.
at baseline (up to 3 weeks)
Responsiveness of the italian version of the PRO-CTCAE
Evaluation of responsiveness (ability of an instrument to show a change when there has been a change in the phenomenon) of single items of the PRO-CTCAE for each of the types of cancer considered.
at 3 weeks (up to 6 weeks)
Secondary Outcomes (1)
Differences in psychometric measures according to tumor type and treatment
at 3 weeks (up to 6 weeks)
Interventions
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: * the European Organisation for Research and Treatment of Cancer (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
Any type of cancer
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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
Padua, 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
Related Publications (1)
Caminiti C, Maglietta G, Arenare L, Di Liello R, Migliaccio G, Barberio D, De Laurentiis M, Di Rella F, Nuzzo F, Pacilio C, Iodice G, Orditura M, Ciardiello F, Di Bella S, Cavanna L, Porta C, Giovanardi F, Ripamonti CI, Bilancia D, Aprile G, Ruelle T, Diodati F, Piccirillo MC, Iannelli E, Pinto C, Perrone F. Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE(R)) in breast cancer patients: The prospective observational multicenter VIP study. Breast. 2024 Oct;77:103781. doi: 10.1016/j.breast.2024.103781. Epub 2024 Jul 20.
PMID: 39059033DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Perrone, MD, PhD
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 4, 2020
Study Start
July 1, 2018
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
March 24, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share