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Malignant NeoplasmsNCT04416672

Validation of the Italian Version of the PRO-CTCAE

An observational study of Malignant Neoplasms, run by National Cancer Institute, Naples at 25 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasms
What is being tested?
PRO-CTCAE items
How many people
3,675 participants
Where
25 sitesItaly
Study dates
1 Jul 2018to Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any type of cancer

Who may be able to join

  • 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)
Show all 9Show fewer
  • Able to complete questionnaire by themselves or with assistance, by using a tablet
  • Able to speak and understand Italian
  • Providing informed written consent

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country.

Francesco Perrone, MD, PhD contact

+390815903571 ext. +390815903571

f.perrone@istitutotumori.na.it

25 sites in 1 country

Italy25 sites, 25 recruiting

  • Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II

    Bari

    Domenico Galetta, MD

    Domenico Galetta, MD

    Recruiting

  • U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino

    Brindisi

    Saverio Cinieri, MD

    Saverio Cinieri, MD

    Recruiting

  • Azienda Ospedaliero Universitaria di Cagliar

    Cagliari

    Alberto Sobrero, MD

    Alberto Sobrero, MD

    Recruiting

  • Oncologia Medica 2 - IRCCS AOU San Martino

    Genova

    Lucia Del Mastro, MD

    Lucia Del Mastro, MD

    Recruiting

  • Oncologia - A.O. Cardinale G. Panico

    Lecce

    Emiliano Tamburini, MD

    Emiliano Tamburini, MD

    Recruiting

  • Oncologia Medica - AO Vito Fazzi

    Lecce

    Silvana Leo, MD

    Silvana Leo, MD

    Recruiting

  • Oncologia Medica, Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

    Ugo De Giorgi, MD, PhD

    Ugo De giorgi, MD

    Recruiting

  • A.O.Ospedali Riuniti Papardo Piemonte U.O.C. di Oncologia Medica

    Messina

    Vincenzo Adamo, MD

    Vincenzo Adamo, MD

    Recruiting

  • Fondazione IRCCS, Istituto Nazionale dei Tumori

    Milan

    Carla Ida Ripamonti, MD

    Carla Ida Ripamonti, MD

    Recruiting

  • Ginecologia e Ostetricia - IRCCS Ospedale San Raffaele

    Milan

    Alice Bergamini, MD

    Alice Bergamini, MD

    Recruiting

  • Oncologia - ASST Rhodense - Presidio di Garbagnat

    Milan

    Silvia Della Torre, MD

    Silvia Della Torre, MD

    Recruiting

  • Oncologia - ASST Rhodense - Presidio di Rho

    Milan

    Sara Di Bella, MD

    Sara Di Bella, MD

    Recruiting

  • Istituto Nazionale Tumori, Dip. Uro-Ginecologico S.C. Oncologia Clinica Sperimentale Uro-Ginecologica

    Naples

    Sandro Pignata, MD, PhD

    Sandro Pignata, MD, PhD

    Recruiting

  • Oncologia Medica Toraco-Polmonare -Istituto Nazionale Tumori

    Naples

    Alessandro Morabito, MD

    Alessandro Morabito, MD

    Recruiting

  • Servizio di Oncologia Medica ed Ematologia - DAI di Internistica Polispecialistica- AOU Università degli studi della Campania "Luigi Vanvitelli"

    Naples

    Michele Orditura, MD

    Michele Orditura, MD

    Recruiting

  • Struttura semplice Sarcomi ossa e tessuti molli, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

    Naples

    Antonio Pizzolorusso, MD

    Antonio Pizzolorusso, MD

    Recruiting

  • U.O.C. di Oncologia - Presidio Monaldi - AORN Ospedale dei Colli

    Naples

    Vincenzo Montesarchio, MD, +390817065268, vincenzo.montesarchio@ospedaledeicolli.it

    Vincenzo Montesarchio, MD

    Recruiting

  • Istituto Oncologico Veneto

    Padova

    Vittorina Zagonel, MD

    Vittorina Zagonel, MD

    Recruiting

  • AOU Oncologia Medica

    Parma

    Marcello Tiseo, MD

    Marcello Tiseo, MD

    Recruiting

  • Oncologia traslazionale - ICS Maugeri di Pavia

    Pavia

    Camillo Porta, MD

    Camillo Porta, MD

    Recruiting

  • Oncologia Medica ed Ematologia, USL di Piacenza - Ospedale Guglielmo da Saliceto

    Piacenza

    Luigi Cavanna, MD

    Luigi Cavanna, MD

    Recruiting

  • Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"

    Roma

    Patrizia Vici, MD

    Patrizia Vici, MD

    Recruiting

  • UOC Oncologia Medica 1 - Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena

    Roma

    Antonella Savarese, MD

    Antonella Savarese, MD

    Recruiting

  • Oncologia - Ospedale S. G. Moscati

    Taranto

    Salvatore Pisconti, MD

    Salvatore Pisconti, MD

    Recruiting

  • Oncologia Medica - Istituto Sacro Cuore Don Calabria

    Verona

    Stefania Gori, MD

    Stefania Gori, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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
Being tested
PRO-CTCAE items
Keywords
PRO-CTCAE, EORTC QLQ-C30 or Disease-Specific Questionnaire, HADS, PGIC Scale, Performance Status, Quality of Life
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO-CTCAE itemsOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at baseline (up to 3weeks)

  2. 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

    Measured: at 3 weeks (up to 6 weeks)

  3. 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.

    Measured: at baseline (up to 3 weeks)

  4. 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.

    Measured: at 3 weeks (up to 6 weeks)

Secondary outcomes (1)

  1. 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, ...)

    Measured: at 3 weeks (up to 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Jul 2018
  3. Primary completionJul 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3,675 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416672
Sponsor's protocol ID
VIP
Status last verified
Mar 2023
First submitted
29 May 2020
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39059033

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Neoplasms, run by National Cancer Institute, Naples at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francesco Perrone, MD, PhD (+390815903571 ext. +390815903571, f.perrone@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity of the italian version of the PRO-CTCAE (time frame: at baseline (up to 3weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04416672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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