Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy
NCT ID: NCT03473379
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
440 participants
OBSERVATIONAL
2018-03-01
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Phase 1: concept elicitation and coding
The aim of this phase is to elicit concepts from patients, caregivers, and oncology clinicians through focus groups of patients and caregivers, qualitative interviews and surveys. Approximately 55 patients or caregivers will participate in this phase.
No interventions assigned to this group
Phase 2: Item generation and analysis
The aim of this phase is produce a draft version of the questionnaire. Approximately 90 patients or caregivers will be recruited in this phase for item ranking and analysis through questionnaire evaluation and cognitive interviews.
No interventions assigned to this group
Phase 3: Instrument refinement and internal validation
The aim of this phase is generate the final version of the instrument. Approximately 101 patients or caregivers will participate in this phase by completing the questionnaire
No interventions assigned to this group
Phase 4: External validation
In this phase the questionnaire will undergo further psychometric testing for validation and approximately 220 patients or caregivers will be asked to complete the PROFTC-I questionnaire along with quality of life instruments
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 who have never received anticancer medical or radiation treatment
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Francesco Perrone
Role: PRINCIPAL_INVESTIGATOR
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Jane Bryce
Role: PRINCIPAL_INVESTIGATOR
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Ciro Gallo
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Silvia Riva
Role: PRINCIPAL_INVESTIGATOR
St. Mary University, Twickenham, London, GB
Fabio Efficace
Role: PRINCIPAL_INVESTIGATOR
Northwestern University, Feinberg School of Medicine, GIMEMA,EORTC Quality of Life Group - Rappresentante GIMEMA
Francesco De Lorenzo
Role: PRINCIPAL_INVESTIGATOR
AIMAC and European Cancer Patient Coalition
Elisabetta Iannelli
Role: PRINCIPAL_INVESTIGATOR
Segretario Generale FAVO
Laura Del Campo
Role: PRINCIPAL_INVESTIGATOR
FAVO
Francesca Traclò
Role: PRINCIPAL_INVESTIGATOR
AIMAC
Massimo Di Maio
Role: PRINCIPAL_INVESTIGATOR
AO Ordine Mauriziano
Luciano Frontini
Role: PRINCIPAL_INVESTIGATOR
Federation of Italian Cooperative Oncology Groups
Vincenzo Montesarchio
Role: PRINCIPAL_INVESTIGATOR
Oncologia, Azienda dei Colli, Napoli - CIPOMO
Lara Gitto
Role: PRINCIPAL_INVESTIGATOR
Centro per gli Studi Economici e Internazionali - Economic Evaluation & Health Technology Assessment (CEIS EEHTA), Università di Roma "Tor Vergata"
Claudio Jommi
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale; Osservatorio Farmaci, Cergas, SDA Bocconi
Concetta Maria Vaccaro
Role: PRINCIPAL_INVESTIGATOR
Welfare e Salute CENSIS (Centro Studi Investimenti Sociali), Roma
Locations
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Azienda dei Colli
Napoli, , Italy
Istituto Nazionale Tumori, IRCCS Fondazione Pascale
Napoli, , Italy
Istituto Nazionale Tumori Regina Elena - IRCCS - IFO
Roma, , Italy
Policlinico Universitario Campus Biomedico
Roma, , Italy
AO Ordine Mauriziano
Torino, , Italy
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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PROFTC-I
Identifier Type: -
Identifier Source: org_study_id
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