Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy (PROFTC-I)

Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 440

Contacts and Locations

• Study Contact: Name: Francesco Perrone; Phone Number: 0815903571; Email: f.perrone@istitutotumori.na.it
• Study Contact Backup: Name: Jane Bryce; Phone Number: 0815903571; Email: j.bryce@istitutotumori.na.it

Study Locations

• Italy
  • Napoli, Italy
    • Recruiting
    • Azienda dei Colli
  • Napoli, Italy
    • Recruiting
    • Istituto Nazionale Tumori, IRCCS Fondazione Pascale
  • Roma, Italy
    • Recruiting
    • Istituto Nazionale Tumori Regina Elena - IRCCS - IFO
  • Roma, Italy
    • Not yet recruiting
    • Policlinico Universitario Campus Biomedico
  • Torino, Italy
    • Recruiting
    • AO Ordine Mauriziano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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..

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.
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.
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of Patient reported outcome financial toxicity of cancer Italian(PROFTC-I) questionnaire	During the development of the questionnaire, individual items (questions), response options, and type of scoring will be determined according to Phases 1-3. Subsequently a principal components analysis (explorative factor analysis) will be done with eigen value set at 1; internal reliability will be assessed by inter-item correlations and Cronbach's alpha ( minimum acceptable 0.70); intraclass correlation coefficient (minimum acceptable 0.80). Correlation of final instrument with the EORTC quality of life questionnaire (criterion validity) will be assessed with using Pearson correlation coefficient.	48 months

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Francesco Perrone, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale; Principal Investigator: Jane Bryce, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale; Principal Investigator: Ciro Gallo, Università degli studi della Campania Luigi Vanvitelli; Principal Investigator: Silvia Riva, St. Mary University, Twickenham, London, GB; Principal Investigator: Fabio Efficace, Northwestern University, Feinberg School of Medicine, GIMEMA,EORTC Quality of Life Group - Rappresentante GIMEMA; Principal Investigator: Francesco De Lorenzo, AIMAC and European Cancer Patient Coalition; Principal Investigator: Elisabetta Iannelli, Segretario Generale FAVO; Principal Investigator: Laura Del Campo, FAVO; Principal Investigator: Francesca Traclò, AIMAC; Principal Investigator: Massimo Di Maio, AO Ordine Mauriziano; Principal Investigator: Luciano Frontini, Federation of Italian Cooperative Oncology Groups; Principal Investigator: Vincenzo Montesarchio, Oncologia, Azienda dei Colli, Napoli - CIPOMO; Principal Investigator: Lara Gitto, Centro per gli Studi Economici e Internazionali - Economic Evaluation & Health Technology Assessment (CEIS EEHTA), Università di Roma "Tor Vergata"; Principal Investigator: Claudio Jommi, Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale; Osservatorio Farmaci, Cergas, SDA Bocconi; Principal Investigator: Concetta Maria Vaccaro, Welfare e Salute CENSIS (Centro Studi Investimenti Sociali), Roma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: economic difficulty, financial toxicity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: PROFTC-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No