Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study

Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)

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).

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.

Inclusion Criteria:

• Patients older than 18 years of age.

Histological diagnosis of malignancy for which the patient requires radiotherapy treatment.

Exclusion Criteria:

• Patient refusal to complete the questionnaire.