Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT07175350
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study
Sponsor:
Valerio Nardone
Organization:
Study Overview
Official Title:
Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)
Status:
RECRUITING
Status Verified Date:
2025-09
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:
FIT-RT
Brief Summary:
Non- profit, multicenter, prospective, observational study. The study aims to assess financial toxicity (FT) in patients undergoing radiotherapy for oncological diseases, assessed with a validated questionnaire (Patient Reported Outcome for Fighting FInancial Toxicity-PROFFIT- questionnaire).
Detailed Description:
PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. The primary objective of the study is to assess FT in patients undergoing radiotherapy for oncological diseases and compare FT in different patients group defined according to baseline characteristics (oncologic disease, type of radiotherapy and treatment, age and sex).
Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline (before starting radiotherapy), at the end of RT treatment, at first follow-up visit (1-2 months after the end of RT).
Exploratory analyses will be conducted to verify whether changes in the FT score during treatment are correlated with QOL (EORTC QLQ-C30 questionnaire), toxicity (PRO-CTCAE), and overall survival.
Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline (before starting radiotherapy), at the end of RT treatment, at first follow-up visit (1-2 months after the end of RT).
Exploratory analyses will be conducted to verify whether changes in the FT score during treatment are correlated with QOL (EORTC QLQ-C30 questionnaire), toxicity (PRO-CTCAE), and overall survival.
Study Oversight
Has Oversight DMC:
False
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?: