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Background Financial toxicity in cancer patients has been initially reported in the United States and subsequently in other countries, including Italy, despite a health care system grounded on universal coverage. Considering that the way healthcare and welfare systems are shaped does impact on financial problems faced by cancer patients, we are developing an instrument for evaluating occurrence, gravity, and consequences of financial toxicity in Italy, and hopefully for fighting it. Methods Concept elicitation, item generation and qualitative analyses represented the initial tasks of the project. Literature review, focus groups with 34 cancer patients or caregivers in three regions located in North, Central, and South Italy, and semi-structured interviews with 97 oncologists were conducted for concept elicitation. A recursive process was used to identify themes in the data to inform the instrument until saturation was reached. Importance analysis questionnaires were administered to a further 44 cancer patients to evaluate and revise the draft item pool. A multi-disciplinary committee (including oncologists, psychologists, statisticians, patient association’s representatives, nurses, social science researchers and economists) oversaw the project. Results Overall, 156 concepts were distributed among 10 themes (bureaucracy, medical care, domestic economy, emotion, family, job, health workers, welfare state, free time, transportation). After controlling for redundancy, 55 candidate items were generated and 30 items, with at least one per each theme, remained after importance analysis. Out of the 30 items, 23 (77%) refer to material conditions, 4 (13%) to psychological response, and 3 (10%) to coping behaviors. Conclusions The first results of the proFFiT project show that most of the items selected by patients are related to material conditions that cause, or derive from, financial hardship. The final questionnaire will be ready by the end of 2019. Supported by Fondazione AIRC IG grant 2017-20402. Clinical trial identification NCT03473379. Legal entity responsible for the study Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Pascale IRCCS, Naples, Italy. Funding Fondazione AIRC IG grant 2017-20402. Disclosure S. Riva: Honoraria (self): CSL-Behring; Honoraria (self): GlaxoSmithLine Foundation. M. Di Maio: Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Janssen. F. Efficace: Honoraria (self): BMS; Honoraria (self): Incyte; Honoraria (self): Orsenix; Honoraria (self): Amgen. V. Montesarchio: Honoraria (self): BMS; Honoraria (self): Italfarmaco; Spouse / Financial dependant: Bayer. F. Perrone: Honoraria (self): AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Celgene; Honoraria (self): Incyte; Honoraria (self): Janssen-Cilag; Honoraria (self): Pierre Fabre; Honoraria (self): Sandoz. All other authors have declared no conflicts of interest.