Clinical trial NCT03473379: Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy
Official title: Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: economic difficulty, financial toxicity
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any type of solid cancer or haematological malignancy who has undergone medical treatment, including chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy and combinations of such therapies, or their caregivers, will be recruited in northern, central and southern Italian hospitals..

Brief summary: The aim of this study is to develop and validate a patient-reported-outcome instrument (PROFTC-I: Patient Reported Outcome Financial Toxicity in Cancer - Italy) able to describe and measure financial problems of Italian patients receiving cancer treatment.

Detailed description: The project will be conducted according to the methodology delineated by the International Society for Pharmacoeconomics and Outcome Research (ISPOR) Patient Reported Outcomes Content Validity Good Research Practices Task Force in the following phases: concept elicitation and coding, item generation and analysis, instrument refinement and internal validation, and external validation.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years)
* Histologically or cytologically confirmed diagnosis of any type of solid cancer or haematological malignancy
* Written Informed Consent provided
* Medical treatment (chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy or combinations of such therapies) ongoing or terminated within the previous 3 months.
* Caregivers of patients who meet the above criteria

Exclusion Criteria:

* Patients with major cognitive dysfunction or psychiatric disorders
* Patients who have never received anticancer medical or radiation treatment

Primary outcomes:
measure: Validation of Patient reported outcome financial toxicity of cancer Italian(PROFTC-I) questionnaire
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Azienda dei Colli
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori, IRCCS Fondazione Pascale
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena - IRCCS - IFO
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Torino
country: Italy
facility: AO Ordine Mauriziano
Study officials:
affiliation: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: Francesco Perrone
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: Jane Bryce
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary University, Twickenham, London, GB
name: Silvia Riva
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University, Feinberg School of Medicine, GIMEMA,EORTC Quality of Life Group - Rappresentante GIMEMA
name: Fabio Efficace
role: PRINCIPAL_INVESTIGATOR
affiliation: AIMAC and European Cancer Patient Coalition
name: Francesco De Lorenzo
role: PRINCIPAL_INVESTIGATOR
affiliation: Segretario Generale FAVO
name: Elisabetta Iannelli
role: PRINCIPAL_INVESTIGATOR
affiliation: FAVO
name: Laura Del Campo
role: PRINCIPAL_INVESTIGATOR
affiliation: AIMAC
name: Francesca Traclò
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Ordine Mauriziano
name: Massimo Di Maio
role: PRINCIPAL_INVESTIGATOR
affiliation: Federation of Italian Cooperative Oncology Groups
name: Luciano Frontini
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncologia, Azienda dei Colli, Napoli - CIPOMO
name: Vincenzo Montesarchio
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro per gli Studi Economici e Internazionali - Economic Evaluation & Health Technology Assessment (CEIS EEHTA), Università di Roma "Tor Vergata"
name: Lara Gitto
role: PRINCIPAL_INVESTIGATOR
affiliation: Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale; Osservatorio Farmaci, Cergas, SDA Bocconi
name: Claudio Jommi
role: PRINCIPAL_INVESTIGATOR
affiliation: Welfare e Salute CENSIS (Centro Studi Investimenti Sociali), Roma
name: Concetta Maria Vaccaro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riva S, Arenare L, Di Maio M, Efficace F, Montesarchio V, Frontini L, Giannarelli D, Bryce J, Del Campo L, De Lorenzo F, Iannelli E, Traclo F, Gitto L, Jommi C, Vaccaro CM, Barberio D, Cinieri S, Porta C, Del Mastro L, Zagonel V, Cogoni AA, Bordonaro R, Gimigliano A, Piccirillo MC, Guizzaro L, Gallo C, Perrone F. Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system. BMJ Open. 2021 Oct 20;11(10):e049128. doi: 10.1136/bmjopen-2021-049128.
citation: Riva S, Efficace F, Di Maio M, Bryce J, Del Campo L, De Lorenzo F, Frontini L, Giannarelli D, Gitto L, Iannelli E, Jommi C, Montesarchio V, Traclo F, Vaccaro CM, Arenare L, Canzanella G, Gimigliano A, Romano F, Savio A, Sparavigna L, Piccirillo MC, Guizzaro L, Gallo C, Perrone F. A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system. Support Care Cancer. 2021 Jun;29(6):3219-3233. doi: 10.1007/s00520-020-05840-z. Epub 2020 Oct 22.
citation: Riva S, Bryce J, De Lorenzo F, Del Campo L, Di Maio M, Efficace F, Frontini L, Giannarelli D, Gitto L, Iannelli E, Jommi C, Montesarchio V, Traclo F, Vaccaro CM, Gallo C, Perrone F. Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol. BMJ Open. 2019 Sep 9;9(9):e031485. doi: 10.1136/bmjopen-2019-031485.