Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04416672
Status:
RECRUITING
Last Update Posted:
2023-03-24
First Post:
2020-05-29
Brief Title:
Validation of the Italian Version of the PRO-CTCAE
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None