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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07175350

Acronym

FIT-RT

Enrollment

1000

Registered

2025-09-16

Start date

2024-09-06

Completion date

2026-06-01

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncologic Diseases

Keywords

Oncologic Diseases, Radiotherapy, Financial toxicity, PROFFIT questionnaire, Quality of Life

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.

Interventions

OTHERPROFFIT

The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16); EORTC QLQ-C30 questionnaire is a 30-item questionnaire that measures health-related quality of life (HRQOL) in cancer patients ; PRO-CTCAE is a short list of 43 symptoms relevant for ovarian cancer

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Financial toxicity (PROFFIT financial score and determinants)	baseline (before starting RT), periprocedural (end of radiotherapy treatment, average of 1-2 months); 1-2 months after the end of RT(first follow-up visit) up to 12 months.	PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485). The baseline score for determinants (items 8-16) and their change during treatment

Other

Measure	Time frame	Description
Quality of Life (QoL)	baseline (before starting RT), periprocedural (end of radiotherapy treatment, average of 1-2 months); 1-2 months after the end of RT(first follow-up visit) up to 12 months.	QoL will be assessed using EORTC QLQ-C30 questionnaire and selected symptoms of the PRO-CTCAE library.

Countries

Italy

Contacts

Primary ContactRoberta Grassi, MD

grassi.roberta89@gmail.com3333385815

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026