{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T11:37:33Z","timestamp":1784893053744,"version":"3.55.0"},"reference-count":29,"publisher":"BMJ","issue":"9","funder":[{"DOI":"10.13039\/501100005010","name":"Associazione Italiana per la Ricerca sul Cancro","doi-asserted-by":"publisher","award":["IG 2017 - id 20402"],"award-info":[{"award-number":["IG 2017 - id 20402"]}],"id":[{"id":"10.13039\/501100005010","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,8,28]]},"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Financial toxicity (FT) is a well-recognised problem in oncology. US-based studies have shown that: (a) cancer patients have a 2.7 times risk of bankruptcy; (b) patients who declare bankruptcy have a 79% greater hazard of death; (c) financial burden significantly impairs quality of life (QoL) and (d) reduces compliance and adherence to treatment prescriptions. The aim of the project is to develop and validate a patient-reported-outcome (PRO) measure to assess FT of cancer patients in Italy, where, despite the universal health coverage provided by the National Health Service, FT is an emerging issue.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Our hypothesis is that a specific FT measure, which considers the relevant sociocultural context and healthcare system, would allow us to understand the main determinants of cancer-related FT in Italy, in order to address and reduce these factors. According to the International Society for Pharmaco-economics and Outcomes Research guidelines on PROs, the project will include the following steps: (1) concept elicitation (from focus groups with patients and caregivers; literature; oncologists; nurses) and analysis, creating a coding library; (2) item generation (using a format that includes a question and a response on a 4-point Likert scale) and analysis through patients\u2019 cognitive interviews of item importance within different coding categories to produce the draft instrument; (3) factor analysis and internal validation (with Cronbach\u2019s alpha and test\u2013retest for reliability) to produce the final instrument; (4) external validation with QoL anchors and depression scales. The use of the FT measure in prospective trials is also planned.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol is approved by the ethical committees of all the participating centres. The project will tentatively produce a validated tool by the spring 2021. The project might also represent a model and the basis for future cooperation with other European countries, with different healthcare systems and socioeconomic conditions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03473379\">NCT03473379<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-031485","type":"journal-article","created":{"date-parts":[[2019,9,9]],"date-time":"2019-09-09T16:25:15Z","timestamp":1568046315000},"page":"e031485","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03473379","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Silvia","family":"Riva","sequence":"first","affiliation":[{"name":"Department of Psychology and Pedagogical Science, Faculty of Sport, Health and Applied Science, St.Mary's University, Twickenham, London, UK"},{"name":"Dipartimento di Medicina Interna, IRCCS Ca\u2019 Granda Foundation, Universit\u00e0 di Milano, Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Bryce","sequence":"additional","affiliation":[{"name":"Unit\u00e0 Sperimentazioni Cliniche, Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Pascale, Napoli, Italy"},{"name":"St. John Clinical Research Institute, St. John Medical Center, Tulsa, Oklahoma, USA"},{"name":"Departmento di Biomedicina e Prevenzione, Universit\u00e0 degli Studi di Roma Tor Vergata, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"De Lorenzo","sequence":"additional","affiliation":[{"name":"Associazione Italiana Malati di Cancro (AIMAC), Roma, Italy"},{"name":"European Cancer Patient Coalition (ECPC), Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Del Campo","sequence":"additional","affiliation":[{"name":"Federazione italiana delle Associazioni di Volontariato in Oncologia (FAVO), Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Di Maio","sequence":"additional","affiliation":[{"name":"Dipartimento di Oncologia, AO Ordine Mauriziano, Universit\u00e0 degli Studi di Torino, Torino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Efficace","sequence":"additional","affiliation":[{"name":"Health Outcomes Research Unit, Fondazione GIMEMA, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luciano","family":"Frontini","sequence":"additional","affiliation":[{"name":"Federation of Italian Cooperative Oncology Groups (FICOG), Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Giannarelli","sequence":"additional","affiliation":[{"name":"Unit\u00e0 di Biostatistica, Istituto Nazionale per lo Studio e la Cura dei Tumori Regina Elena, IRCCS, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Gitto","sequence":"additional","affiliation":[{"name":"Dipartimento di Economia, Universit\u00e0 degli Studi di Messina, Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Iannelli","sequence":"additional","affiliation":[{"name":"Federazione italiana delle Associazioni di Volontariato in Oncologia (FAVO), Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Jommi","sequence":"additional","affiliation":[{"name":"Practice, Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Montesarchio","sequence":"additional","affiliation":[{"name":"Oncologia, Azienda Ospedaliera Specialistica dei Colli, Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Tracl\u00f2","sequence":"additional","affiliation":[{"name":"Associazione Italiana Malati di Cancro (AIMAC), Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Concetta Maria","family":"Vaccaro","sequence":"additional","affiliation":[{"name":"Area Welfare e Salute, Censis - Centro Studi Investimenti Sociali, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciro","family":"Gallo","sequence":"additional","affiliation":[{"name":"Statistica Medica, Universit\u00e0 degli Studi della Campania Luigi Vanvitelli, Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Perrone","sequence":"additional","affiliation":[{"name":"Unit\u00e0 Sperimentazioni Cliniche, Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Pascale, Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,9,9]]},"reference":[{"key":"2025120600591302000_9.9.e031485.1","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1001\/jamaoncol.2015.0373","article-title":"Five years of cancer drug approvals: innovation, efficacy, and costs","volume":"1","author":"Mailankody","year":"2015","journal-title":"JAMA Oncol"},{"key":"2025120600591302000_9.9.e031485.2","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1001\/jamaoncol.2015.4191","article-title":"Perspectives on cost and value in cancer care","volume":"2","author":"Saltz","year":"2016","journal-title":"JAMA Oncol"},{"key":"2025120600591302000_9.9.e031485.3","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2012.1263"},{"key":"2025120600591302000_9.9.e031485.4","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2013-0374"},{"key":"2025120600591302000_9.9.e031485.5","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2012-0279"},{"key":"2025120600591302000_9.9.e031485.6","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.63.2232"},{"key":"2025120600591302000_9.9.e031485.7","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1200\/JOP.2014.001542","article-title":"Population-Based assessment of cancer survivors' financial burden and quality of life: a prospective cohort study","volume":"11","author":"Zafar","year":"2015","journal-title":"JOP"},{"key":"2025120600591302000_9.9.e031485.8","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2015-0026"},{"key":"2025120600591302000_9.9.e031485.9","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.64.6620"},{"key":"2025120600591302000_9.9.e031485.10","first-page":"2221","article-title":"Out-of-pocket-payments and the financial burden of 502 cancer patients of working age in Germany: results from a longitudinal study","volume":"27","author":"B\u00fcttner","year":"2019","journal-title":"Support Care Cancer"},{"key":"2025120600591302000_9.9.e031485.11","doi-asserted-by":"crossref","DOI":"10.1016\/j.cllc.2018.12.010","article-title":"Financial burden among patients with lung cancer in a Publically funded health care system","volume":"20","author":"Ezeife","year":"2019","journal-title":"Clin Lung Cancer"},{"key":"2025120600591302000_9.9.e031485.12","doi-asserted-by":"crossref","DOI":"10.3332\/ecancer.2018.847","article-title":"A prospective survey of comprehensive score for financial toxicity in Japanese cancer patients: report on a pilot study","volume":"12","author":"Honda","year":"2018","journal-title":"Ecancermedicalscience"},{"key":"2025120600591302000_9.9.e031485.13","first-page":"3543","article-title":"Out-Of-Pocket expenses experienced by rural Western Australians diagnosed with cancer","volume":"26","author":"Newton","year":"2018","journal-title":"Support Care Cancer"},{"key":"2025120600591302000_9.9.e031485.14","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.28814"},{"key":"2025120600591302000_9.9.e031485.15","doi-asserted-by":"crossref","unstructured":"Altice CK , Banegas MP , Tucker-Seeley RD , et al . Financial Hardships experienced by cancer survivors: a systematic review. J Natl Cancer Inst 2016.","DOI":"10.1093\/jnci\/djw205"},{"key":"2025120600591302000_9.9.e031485.16","doi-asserted-by":"crossref","first-page":"476","DOI":"10.1002\/cncr.30369","article-title":"Measuring financial toxicity as a clinically relevant patient-reported outcome: the validation of the comprehensive score for financial toxicity (cost)","volume":"123","author":"de Souza","year":"2017","journal-title":"Cancer"},{"key":"2025120600591302000_9.9.e031485.17","first-page":"1","article-title":"Prospective survey of financial toxicity measured by the comprehensive score for financial toxicity in Japanese patients with cancer","volume":"5","author":"Honda","year":"2019","journal-title":"J Glob Oncol"},{"key":"2025120600591302000_9.9.e031485.18","doi-asserted-by":"crossref","first-page":"e408","DOI":"10.1016\/S2352-3026(15)00151-9","article-title":"Scott F Huntington BMW, DAN T Vogl, ADAM D Cohen, Alfred L Garfall, Patricia a Mangan, Jalpa a Doshi, Edward a Stadtmauer. financial toxicity in insured patients with multiple myeloma: a cross-sectional pilot study","volume":"2","year":"2015","journal-title":"Lancet Haematol"},{"key":"2025120600591302000_9.9.e031485.19","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw433"},{"key":"2025120600591302000_9.9.e031485.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.013"},{"key":"2025120600591302000_9.9.e031485.21","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.014"},{"key":"2025120600591302000_9.9.e031485.22","doi-asserted-by":"publisher","DOI":"10.1177\/160940690900800301"},{"key":"2025120600591302000_9.9.e031485.23","unstructured":"Glaser BG . Theoretical sensitivity. Mill Valley, CA: Sociology Press, 1978."},{"key":"2025120600591302000_9.9.e031485.24","unstructured":"Glaser BG . Discovery of grounded theory. Chicago, IL: Aldine, 1992."},{"key":"2025120600591302000_9.9.e031485.25","doi-asserted-by":"publisher","DOI":"10.1185\/03007990902774765"},{"key":"2025120600591302000_9.9.e031485.26","unstructured":"Heritage J . Conversation analysis and institutional talk: Analyzing data. In: Silverman D , ed. Qualitative research: theory, method, and practice. Thousand Oaks, CA: Sage, 2004: 222\u201345."},{"key":"2025120600591302000_9.9.e031485.27","first-page":"281","article-title":"Typology of mixed methods sampling designs in social science research","volume":"12","author":"Onwuegbuzie","year":"2007","journal-title":"The Qualitative Report"},{"key":"2025120600591302000_9.9.e031485.28","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980115)17:1<101::AID-SIM727>3.0.CO;2-E"},{"key":"2025120600591302000_9.9.e031485.29","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/85.5.365"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-031485","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T08:59:21Z","timestamp":1765011561000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-031485"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,9]]},"references-count":29,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2019,9,9]]},"published-print":{"date-parts":[[2019,9]]}},"alternative-id":["10.1136\/bmjopen-2019-031485"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-031485","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,9]]}}}