Financial burden for radiotherapy patients in Italy
Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)
This project will use a short Italian questionnaire to see if people getting radiotherapy in Italy face financial problems before, during, and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 7 sites (Barletta and 6 other locations) |
| Trial ID | NCT07175350 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational study using the validated Italian PROFFIT questionnaire to measure financial toxicity in adults receiving radiotherapy for cancer. Participants complete the PROFFIT at baseline (before radiotherapy), at the end of treatment, and at the first follow-up visit (1–2 months after treatment). The study compares financial toxicity across groups defined by cancer type, radiotherapy type and treatment details, age, and sex. Exploratory analyses will look for correlations between changes in financial toxicity and quality of life, patient-reported toxicity, and overall survival.
Who should consider this trial
Good fit: Adults (18+) with a histologically confirmed malignancy who are scheduled to receive radiotherapy at one of the participating Italian centers and who are willing and able to complete the PROFFIT questionnaire.
Not a fit: Patients under 18, those not receiving radiotherapy, or those who refuse or are unable to complete the questionnaire are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify which patients are most at risk of financial hardship from radiotherapy and inform targeted support or policy changes.
How similar studies have performed: The PROFFIT questionnaire has been validated in the Italian context and other oncology financial-toxicity instruments have shown usefulness, but longitudinal multicenter data focused on radiotherapy patients remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barletta and 6 other locations
- Radioterapia Oncologica - Ospedale Mons. Dimiccoli — Barletta, Italy (Recruiting)
- Unità di Radioterapia - Responsible Research Hospital — Campobasso, Italy (Recruiting)
- Radioterapia oncologica - Ospedale "Vito Fazzi" - — Lecce, Italy (Recruiting)
- AOU "L. Vanvitelli" - UOC Radioterapia — Naples, Italy (Recruiting)
- .C. Radioterapia - INT G. Pascale — Naples, Italy (Recruiting)
- Radioterapia Oncologica, IRCCS-CROB — Potenza, Italy (Recruiting)
- UOC Radioterapia - Fondazione Policlinico A. Gemelli — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Roberta Grassi, MD — AOU "L. Vanvitelli" - UOC Radioterapia
- Study coordinator: Roberta Grassi, MD
- Email: grassi.roberta89@gmail.com
- Phone: 3333385815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.