NCT04416672

Validation of the Italian Version of the PRO-CTCAE

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,675 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Malignant Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2020-06-04
• Last updated: 2023-03-24

Locations

25 sites across 1 country: Italy