Validation of the Italian Version of the PRO-CTCAE

March 23, 2023 updated by: National Cancer Institute, Naples

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

3675

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bari, Italy
        • Recruiting
        • Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II
        • Principal Investigator:
          • Domenico Galetta, MD
      • Brindisi, Italy
        • Recruiting
        • U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino
        • Contact:
          • Saverio Cinieri, MD
      • Cagliari, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria di Cagliar
        • Principal Investigator:
          • Alberto Sobrero, MD
        • Contact:
          • Alberto Sobrero, MD
      • Genova, Italy
        • Recruiting
        • Oncologia Medica 2 - IRCCS AOU San Martino
        • Contact:
          • Lucia Del Mastro, MD
      • Lecce, Italy
        • Recruiting
        • Oncologia - A.O. Cardinale G. Panico
        • Contact:
          • Emiliano Tamburini, MD
        • Principal Investigator:
          • Emiliano Tamburini, MD
      • Lecce, Italy
        • Recruiting
        • Oncologia Medica - AO Vito Fazzi
        • Contact:
          • Silvana Leo, MD
      • Meldola, Italy
        • Recruiting
        • Oncologia Medica, Istituto Romagnolo per lo Studio e la Cura dei Tumori
        • Contact:
          • Ugo De Giorgi, MD, PhD
        • Principal Investigator:
          • Ugo De Giorgi, MD
      • Messina, Italy
        • Recruiting
        • A.O.Ospedali Riuniti Papardo Piemonte U.O.C. di Oncologia Medica
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS, Istituto Nazionale dei Tumori
        • Contact:
          • Carla Ida Ripamonti, MD
        • Principal Investigator:
          • Carla Ida Ripamonti, MD
      • Milan, Italy
        • Recruiting
        • Ginecologia e Ostetricia - IRCCS Ospedale San Raffaele
        • Contact:
          • Alice Bergamini, MD
        • Principal Investigator:
          • Alice Bergamini, MD
      • Milan, Italy
        • Recruiting
        • Oncologia - ASST Rhodense - Presidio di Garbagnat
        • Contact:
          • Silvia Della Torre, MD
        • Principal Investigator:
          • Silvia Della Torre, MD
      • Milan, Italy
        • Recruiting
        • Oncologia - ASST Rhodense - Presidio di Rho
        • Contact:
          • Sara Di Bella, MD
        • Principal Investigator:
          • Sara Di Bella, MD
      • Naples, Italy
        • Recruiting
        • Istituto Nazionale Tumori, Dip. Uro-Ginecologico S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
        • Principal Investigator:
          • Sandro Pignata, MD, PhD
        • Contact:
          • Sandro Pignata, MD, PhD
      • Naples, Italy
        • Recruiting
        • Oncologia Medica Toraco-Polmonare -Istituto Nazionale Tumori
        • Principal Investigator:
          • Alessandro Morabito, MD
      • Naples, Italy
        • Recruiting
        • Servizio di Oncologia Medica ed Ematologia - DAI di Internistica Polispecialistica- AOU Università degli studi della Campania "Luigi Vanvitelli"
        • Contact:
          • Michele Orditura, MD
      • Naples, Italy
        • Recruiting
        • Struttura semplice Sarcomi ossa e tessuti molli, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
        • Contact:
          • Antonio Pizzolorusso, MD
        • Principal Investigator:
          • Antonio Pizzolorusso, MD
      • Napoli, Italy
      • Padova, Italy
        • Recruiting
        • Istituto Oncologico Veneto
        • Contact:
          • Vittorina Zagonel, MD
        • Principal Investigator:
          • Vittorina Zagonel, MD
      • Parma, Italy
        • Recruiting
        • AOU Oncologia Medica
        • Contact:
          • Marcello Tiseo, MD
      • Pavia, Italy
        • Recruiting
        • Oncologia traslazionale - ICS Maugeri di Pavia
        • Contact:
          • Camillo Porta, MD
      • Piacenza, Italy
        • Recruiting
        • Oncologia Medica ed Ematologia, USL di Piacenza - Ospedale Guglielmo da Saliceto
        • Contact:
          • Luigi Cavanna, MD
      • Roma, Italy
        • Recruiting
        • Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"
        • Contact:
          • Patrizia Vici, MD
        • Principal Investigator:
          • Patrizia Vici, MD
      • Roma, Italy
        • Recruiting
        • UOC Oncologia Medica 1 - Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
        • Principal Investigator:
          • Antonella Savarese, MD
        • Contact:
          • Antonella Savarese, MD
      • Taranto, Italy
        • Recruiting
        • Oncologia - Ospedale S. G. Moscati
        • Principal Investigator:
          • Salvatore Pisconti, MD
      • Verona, Italy
        • Recruiting
        • Oncologia Medica - Istituto Sacro Cuore Don Calabria
        • Contact:
          • Stefania Gori, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any type of cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of the italian version of the PRO-CTCAE
Time Frame: at baseline (up to 3weeks)
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
Time Frame: at 3 weeks (up to 6 weeks)
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
Time Frame: at baseline (up to 3 weeks)
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
Time Frame: at 3 weeks (up to 6 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in psychometric measures according to tumor type and treatment
Time Frame: at 3 weeks (up to 6 weeks)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Francesco Perrone, MD, PhD, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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