Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment

Abstract Background Financial toxicity from cancer treatments is rising as an important patient-reported outcome. Its relevance was first assessed in the context of privately financed healthcare system, where the financial hardship caused by out-of-pocket payments negatively affects survival, while...

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Main Authors: Davide Smussi, Carlo Conti, Luigi Lorini, Davide Mattavelli, Rosella Levaggi, Raffaele Miniaci, Stefano Calza, Alberto Deganello, Consiglia Paduano, Andrea Alberti, Salvatore Grisanti, Carla Ida Ripamonti, Alfredo Berruti, Cesare Piazza, Paolo Bossi
Format: Article
Language:English
Published: BMC 2025-02-01
Series:BMC Cancer
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Online Access:https://doi.org/10.1186/s12885-024-13230-5
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author Davide Smussi
Carlo Conti
Luigi Lorini
Davide Mattavelli
Rosella Levaggi
Raffaele Miniaci
Stefano Calza
Alberto Deganello
Consiglia Paduano
Andrea Alberti
Salvatore Grisanti
Carla Ida Ripamonti
Alfredo Berruti
Cesare Piazza
Paolo Bossi
author_facet Davide Smussi
Carlo Conti
Luigi Lorini
Davide Mattavelli
Rosella Levaggi
Raffaele Miniaci
Stefano Calza
Alberto Deganello
Consiglia Paduano
Andrea Alberti
Salvatore Grisanti
Carla Ida Ripamonti
Alfredo Berruti
Cesare Piazza
Paolo Bossi
author_sort Davide Smussi
collection DOAJ
description Abstract Background Financial toxicity from cancer treatments is rising as an important patient-reported outcome. Its relevance was first assessed in the context of privately financed healthcare system, where the financial hardship caused by out-of-pocket payments negatively affects survival, while fewer evidence exists on its role in countries where care is financed by the public health care system. Head and Neck Cancer (HNC) patients face an increased risk for financial toxicity due to multimodal treatment and relevant out of pocket costs. The aim of this study was to develop and validate an Italian version of the Canadian Financial Index of Toxicity (FIT) questionnaire, defined FITALY. Methods FIT questionnaire was translated through a forward-backward process by two investigators independently, and the process was reviewed by a certified medical scientific English native speaker. Once reached consensus upon Italian translation, two Health Economics experts were consulted to adapt the questionnaire to Italian socio-economic context. The FITALY questionnaire v1.0 hereby developed was anonymously administered to two consecutive groups of 30 patients who had received curative, multimodal treatment for HNC cancer at ASST Spedali Civili of Brescia, Italy. A cognitive debriefing form was simultaneously administered to ask patients to exclude recurring and redundant items and include new relevant items. Results The 14-item FITALY questionnaire provides a global evaluation of financial toxicity ranging from 0 to 100. The questionnaire is divided into 4 domains: financial burden (6 items), exploring the objective financial toxicity burden; financial distress (2 items), which refers to the psychological distress related to financial toxicity; out-of-pocket costs (4 items), which focus on medical expenses paid by the patient; and loss of productivity (2 items), that investigates the disease impact on both patient’s and caregiver’s job activity. Conclusions Starting from the Canadian 9-item FIT questionnaire, we developed and validated the Italian 14-item FITALY questionnaire. Prospective application to a cohort of Italian HNC patients is ongoing.
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spelling doaj-art-71ca9107fb2e4fc7afc3a1a4303966f82025-08-20T02:15:17ZengBMCBMC Cancer1471-24072025-02-012511810.1186/s12885-024-13230-5Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatmentDavide Smussi0Carlo Conti1Luigi Lorini2Davide Mattavelli3Rosella Levaggi4Raffaele Miniaci5Stefano Calza6Alberto Deganello7Consiglia Paduano8Andrea Alberti9Salvatore Grisanti10Carla Ida Ripamonti11Alfredo Berruti12Cesare Piazza13Paolo Bossi14Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali CiviliUnit of Otorhinolaryngology and Head and Neck Surgery, ASST-Spedali CiviliMedical Oncology and Hematology Unit, IRCCS Humanitas Research HospitalUnit of Otorhinolaryngology and Head and Neck Surgery, ASST-Spedali CiviliDepartment of Economics and Management, University of BresciaDepartment of Economics and Management, University of BresciaBiostatistics, Department of Molecular and Translational Medicine, University of BresciaOtolaryngology Head and Neck Surgery Department, IRCCS National Cancer Institute (INT)Medical Oncology and Hematology Unit, IRCCS Humanitas Research HospitalMedical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali CiviliMedical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali CiviliDepartment of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of BresciaMedical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST-Spedali CiviliUnit of Otorhinolaryngology and Head and Neck Surgery, ASST-Spedali CiviliMedical Oncology and Hematology Unit, IRCCS Humanitas Research HospitalAbstract Background Financial toxicity from cancer treatments is rising as an important patient-reported outcome. Its relevance was first assessed in the context of privately financed healthcare system, where the financial hardship caused by out-of-pocket payments negatively affects survival, while fewer evidence exists on its role in countries where care is financed by the public health care system. Head and Neck Cancer (HNC) patients face an increased risk for financial toxicity due to multimodal treatment and relevant out of pocket costs. The aim of this study was to develop and validate an Italian version of the Canadian Financial Index of Toxicity (FIT) questionnaire, defined FITALY. Methods FIT questionnaire was translated through a forward-backward process by two investigators independently, and the process was reviewed by a certified medical scientific English native speaker. Once reached consensus upon Italian translation, two Health Economics experts were consulted to adapt the questionnaire to Italian socio-economic context. The FITALY questionnaire v1.0 hereby developed was anonymously administered to two consecutive groups of 30 patients who had received curative, multimodal treatment for HNC cancer at ASST Spedali Civili of Brescia, Italy. A cognitive debriefing form was simultaneously administered to ask patients to exclude recurring and redundant items and include new relevant items. Results The 14-item FITALY questionnaire provides a global evaluation of financial toxicity ranging from 0 to 100. The questionnaire is divided into 4 domains: financial burden (6 items), exploring the objective financial toxicity burden; financial distress (2 items), which refers to the psychological distress related to financial toxicity; out-of-pocket costs (4 items), which focus on medical expenses paid by the patient; and loss of productivity (2 items), that investigates the disease impact on both patient’s and caregiver’s job activity. Conclusions Starting from the Canadian 9-item FIT questionnaire, we developed and validated the Italian 14-item FITALY questionnaire. Prospective application to a cohort of Italian HNC patients is ongoing.https://doi.org/10.1186/s12885-024-13230-5Financial toxicityHead and neck cancerQuestionnaire development and validationSupportive carePatient financial burden
spellingShingle Davide Smussi
Carlo Conti
Luigi Lorini
Davide Mattavelli
Rosella Levaggi
Raffaele Miniaci
Stefano Calza
Alberto Deganello
Consiglia Paduano
Andrea Alberti
Salvatore Grisanti
Carla Ida Ripamonti
Alfredo Berruti
Cesare Piazza
Paolo Bossi
Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment
BMC Cancer
Financial toxicity
Head and neck cancer
Questionnaire development and validation
Supportive care
Patient financial burden
title Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment
title_full Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment
title_fullStr Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment
title_full_unstemmed Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment
title_short Financial toxicity questionnaire (FIT): development and validation of the italian version (FITALY) in head and neck cancer patients undergoing multimodal curative treatment
title_sort financial toxicity questionnaire fit development and validation of the italian version fitaly in head and neck cancer patients undergoing multimodal curative treatment
topic Financial toxicity
Head and neck cancer
Questionnaire development and validation
Supportive care
Patient financial burden
url https://doi.org/10.1186/s12885-024-13230-5
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