Validation of the Italian Version of the PRO-CTCAE

Malignant Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416672
• Other study ID #: VIP
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: Francesco Perrone, MD, PhD
• Phone: +390815903571
• Email: f.perrone[@]istitutotumori.na.it
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3675
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasms
• Neoplasms

Intervention

Other:
• PRO-CTCAE items
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.

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Differences in psychometric measures according to tumor type and treatment	Evaluate any differences in psychometric measures according to: type of cancer (breast, lung, liver ...); type of treatment (chemotherapy, hormone therapy, immunotherapy, ...)	at 3 weeks (up to 6 weeks)