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. 2023 Dec;8(6):102192.
doi: 10.1016/j.esmoop.2023.102192. Epub 2023 Dec 5.

Confirmatory validation analysis of the PROFFIT questionnaire to assess financial toxicity in cancer patients

L Arenare  1 , C Porta  2 , D Barberio  3 , S Terzolo  4 , V Zagonel  5 , S Pisconti  6 , L Del Mastro  7 , C Pinto  8 , D Bilancia  9 , S Cinieri  10 , M Rizzo  11 , G Migliaccio  3 , V Montesarchio  12 , L Del Campo  13 , F De Lorenzo  14 , E Iannelli  15 , F Traclò  16 , L Gitto  17 , M C Vaccaro  18 , L Frontini  19 , D Giannarelli  20 , J Bryce  21 , M C Piccirillo  1 , C Jommi  22 , F Efficace  23 , S Riva  24 , M Di Maio  4 , C Gallo  25 , F Perrone  26
Affiliations

Confirmatory validation analysis of the PROFFIT questionnaire to assess financial toxicity in cancer patients

L Arenare et al. ESMO Open. 2023 Dec.

Abstract

Background: The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire was developed to measure financial toxicity (FT) and identify its determinants. The aim of the present study was to confirm its validity in a prospective cohort of patients receiving anticancer treatment.

Patients and methods: From March 2021 to July 2022, 221 patients were enrolled at 10 Italian centres. Selected items of the EORTC-QLQ-C30 questionnaire represented the anchors, specifically, question 28 (Q-28) on financial difficulties, and questions 29-30 measuring global health status/quality of life (HR-QOL). The study had 80% power to detect a 0.20 correlation coefficient (r) between anchors and PROFFIT-score (items 1-7, range 0-100, 100 indicating maximum FT) with bilateral alpha 0.05 and 80% power. Confirmatory factor analysis was conducted. FT determinants (items 8-16) were described.

Results: Median age of patients was 65 years, 116 (52.5%) were females, 96 (43.4%) had low education level. Confirmatory factor analysis confirmed goodness of fit of the PROFFIT-score. Significant partial correlation of PROFFIT-score was found with Q-28 (r = 0.51) and HR-QOL (r = -0.23). Mean (SD) PROFFIT-score at baseline was 36.5 (24.9); it was statistically significantly higher for patients living in South Italy, those with lower education level, those who were freelancer/unemployed at diagnosis and those who reported significant economic impact from the COVID-19 pandemic. Mean (SD) scores of determinants ranged from 17.6 (27.1) for item 14 (support from medical staff) to 49.0 (36.3) for item 10 (expenses for medicines or supplements). PROFFIT-score significantly increased with worsening response to determinants.

Conclusions: External validation of PROFFIT-score in an independent sample of patients was successful. The instrument is now being used in clinical studies.

Trial registration: ClinicalTrials.gov 03473379.

Keywords: PROFFIT; financial toxicity; health economics; patient reported outcomes; quality of life.

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Conflict of interest statement

SC declared non-financial interests as President Italian Society of Medical Oncology (AIOM). LDC, FDL, and EI declared institutional grants or contracts from Novartis, Roche, AstraZeneca, Gilead Sciences, Viatris, Bristol Myers Squibb, Daiichi Sankyo Italia, GlaxoSmithKline, Ipsen, Servier, AbbVie, Boehringer Ingelheim Italia, Becton Dickinson Italia, Mylan, Clovis Oncology IT, Sandoz. LDM declared institutional grants or contracts from Eli Lilly, Novartis, Roche, Daiichi Sankyo, Seagen, Astrazeneca, Gilead, Pierre Fabre; and personal fees for consulting, honoraria, advisory or data safety monitoring board from Eli Lilly, Gilead, Daiichi Sankyio, Roche, Novartis, Pfizer, Astrazeneca, MSD, Seagen, Pierre Fabre, Eisai, Exact Science, Ipsen, GSK, Agendia, Stemline. MDM declared institutional grants or contracts from Tesaro/GlaxoSmithKline, Beigene, Exelixis, MSD, Pfizer and Roche. FE declared personal fees for consulting activities from AbbVie, Incyte, Janssen, Syros, Novartis. CJ declared institutional grants or contracts from Abbvie, AstraZeneca, Bayer, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Incyte, Janssen Cilag, Lundbeck, Merck Sharp & DohmeMerck Sharp & Dohme, Novartis, Roche, Pfizer, Sandoz, Sanofi; consulting fees from Amgen, Astrazeneca, Gilead, Incyte, Sanofi, Takeda; honoraria from MSD, Takeda; personal fees for participation on advisory boards from Amgen, Astrazeneca, BMS, Gilead, Incyte, Roche, Sanofi. FP declared institutional funding from Associazione Italiana per la Ricerca sul Cancro (AIRC) for the present study; institutional support or grants for clinical trials from Roche, Bayer, AstraZeneca, Pfizer, Incyte, Tesaro/GSK, Merck; personal fees for participation on advisory boards from Bayer, Pierre Fabre, AstraZeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, Roche, Pfizer. MCP declared institutional grants from Roche, AstraZeneca, Bayer; honoraria for educational activities from Astellas, Pfizer, Ipsen, AstraZeneca. CP declared consulting fees from Angelini Pharma, Astra Zeneca, BMS, Eisai, Ipsen, MSD; honoraria from Angelini PharmaAngelini Pharma, Astra Zeneca, BMS, Eisai, Ipsen, MSD. SR declared institutional grant from Moderna; honoraria from Roche. MR declared personal fees from MSD, Astra Zeneca, BMS, Eisai, Janssen-Cilag, Merck. MCV declared institutional grants from Roche, MSD, Novo Nordisk; leadership or fiduciary role within Health City Institute; Italian Barometer Diabetes Observatory (IBDO) Foundation, the Kore university Enna; Associazione Italiana Malattia di Alzheimer (AIMA). All other authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
Correlation between PROFFIT-score and financial difficulties (Q-28, question 28 of the EORTC-QLQ-C30, on the left) and HR-QOL (questions 29/30 of the EORTC-QLQ-C30, on the right). Bubble size is proportional to frequency. Solid line represents regression lines.
Figure 2
Figure 2
Box plots of distribution of PROFFIT-score and single items. Thicker lines represent mean values.
See this image and copyright information in PMC

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