Arenare, Laura, Porta, C, Barberio, D, Terzolo, S, Zagonel, V, Pisconti, S, Del Mastro, L, Pinto, C, Bilancia, D, Cinieri, S, Rizzo, M, Migliaccio, G, Montesarchio, Vincenzo, Del Campo, L, De Lorenzo, Francesco, Iannelli, Elisabetta, Gitto, Lara, Vaccaro, Concetta Maria, Frontini, Luciano, Giannarelli, Diana, Bryce, Jane, Iacovino, ML, Piccirillo, Maria Carmela, Jommi, Claudio, Efficace, Fabio, Riva, Silvia 
ORCID: https://orcid.org/0000-0003-2153-0169, Di Maio, Massimo, Gallo, Ciro and Perrone, Francesco
(2025)
Longitudinal validation of the PROFFIT questionnaire to assess financial toxicity in cancer patients.
Journal of Cancer Policy, 46.
ISSN 22135383
DOI: https://doi.org/10.1016/j.jcpo.2025.100645
Abstract
Background
Financial toxicity (FT) is a growing issue for cancer patients worldwide. The PROFFIT questionnaire was developed in Italy to measure FT and identify its determinants in cancer patients within a public health system.
Methods
A prospective study was conducted with 221 cancer patients from 10 Italian centres between March 2021 and July 2022 to validate the PROFFIT questionnaire in patients undergoing active treatment. The PROFFIT and EORTC-QLQ-C30 questionnaires were administered. Statistical analyses were performed on the PROFFIT-score (items 1–7), the financial difficulties item (Q28), and the global health status/quality of life (HR-QOL) scale from the EORTC-QLQ-C30. Geographic disparities were also analysed.
Results
A total of 1149 questionnaires were completed (83 % paper-based, 17 % electronically). The median observation period was 5 months (IQR 4.5–5.8). Missing phenomenon increased over time but was not affected by the baseline PROFFIT-score. PROFFIT-score remained stable throughout treatment, with patients in Southern Italy reporting higher (worse) values. Significant associations (p < 0.0001) were found between PROFFIT-score and Q28 at all time-points. Moderate inverse correlations were observed between PROFFIT-score and HR-QOL.
Conclusions
PROFFIT shows strong longitudinal validity for assessing FT in cancer patients. PROFFIT-score does not significantly change during treatment, but regional disparities highlight the need for targeted interventions, particularly in underserved areas. Further research will define cut-off values and explore FT dynamics across different patient populations.
Policy Summary
PROFFIT validation analyses make the instrument suitable to measure FT in cancer patients within public health systems. In addition, it may represent a valuable tool to plan specific local health policies being sensible to macro-regional variability. Finally, on the long run, it might be useful to test the impact of policies implemented against FT.
