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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute, Naples

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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