Validation of the Italian Version of the PRO-CTCAE

Recruiting

• Conditions: Malignant Neoplasms

• Registration Number: NCT04416672
• Lead Sponsor: National Cancer Institute, Naples

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.

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3675

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity of the italian version of the PRO-CTCAE	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
Responsiveness of the italian version of the PRO-CTCAE	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.

Secondary Outcome Measures

Name	Time	Method
Differences in psychometric measures according to tumor type and treatment	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, ...)

Trial Locations

Locations (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

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