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

NCT03473379 | Unknown

• 1 other identifier: PROFTC-I
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer

Keywords

economic difficulty, financial toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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..

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (5)

Azienda dei Colli

Napoli, Italy

RECRUITING

Istituto Nazionale Tumori, IRCCS Fondazione Pascale

Napoli, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena - IRCCS - IFO

Roma, Italy

RECRUITING

Policlinico Universitario Campus Biomedico

Roma, Italy

NOT YET RECRUITING

AO Ordine Mauriziano

Torino, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 34670762 DERIVED

• 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.

  PMID: 33094357 DERIVED

• 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.

  PMID: 31501130 DERIVED

MeSH Terms

Conditions

Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Francesco Perrone

  Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  PRINCIPAL INVESTIGATOR

• Jane Bryce

  Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  PRINCIPAL INVESTIGATOR

• Ciro Gallo

  University of 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Perrone

CONTACT

0815903571; f.perrone@istitutotumori.na.it

Jane Bryce

CONTACT

0815903571; j.bryce@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: March 1, 2018
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (5)