Confirmatory validation analysis of the PROFFIT questionnaire to assess financial toxicity in cancer patients.

PROFFIT financial toxicity health economics patient reported outcomes quality of life

Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
04 Dec 2023
Historique:
received: 16 10 2023
revised: 03 11 2023
accepted: 07 11 2023
medline: 6 12 2023
pubmed: 6 12 2023
entrez: 5 12 2023
Statut: aheadofprint

Résumé

The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire was developed to measure financial toxicity (FT) and identify its determinants. The aim of the present study was to confirm its validity in a prospective cohort of patients receiving anticancer treatment. From March 2021 to July 2022, 221 patients were enrolled at 10 Italian centres. Selected items of the EORTC-QLQ-C30 questionnaire represented the anchors, specifically, question 28 (Q-28) on financial difficulties, and questions 29-30 measuring global health status/quality of life (HR-QOL). The study had 80% power to detect a 0.20 correlation coefficient (r) between anchors and PROFFIT-score (items 1-7, range 0-100, 100 indicating maximum FT) with bilateral alpha 0.05 and 80% power. Confirmatory factor analysis was conducted. FT determinants (items 8-16) were described. Median age of patients was 65 years, 116 (52.5%) were females, 96 (43.4%) had low education level. Confirmatory factor analysis confirmed goodness of fit of the PROFFIT-score. Significant partial correlation of PROFFIT-score was found with Q-28 (r = 0.51) and HR-QOL (r = -0.23). Mean (SD) PROFFIT-score at baseline was 36.5 (24.9); it was statistically significantly higher for patients living in South Italy, those with lower education level, those who were freelancer/unemployed at diagnosis and those who reported significant economic impact from the COVID-19 pandemic. Mean (SD) scores of determinants ranged from 17.6 (27.1) for item 14 (support from medical staff) to 49.0 (36.3) for item 10 (expenses for medicines or supplements). PROFFIT-score significantly increased with worsening response to determinants. External validation of PROFFIT-score in an independent sample of patients was successful. The instrument is now being used in clinical studies.

Sections du résumé

BACKGROUND BACKGROUND
The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire was developed to measure financial toxicity (FT) and identify its determinants. The aim of the present study was to confirm its validity in a prospective cohort of patients receiving anticancer treatment.
PATIENTS AND METHODS METHODS
From March 2021 to July 2022, 221 patients were enrolled at 10 Italian centres. Selected items of the EORTC-QLQ-C30 questionnaire represented the anchors, specifically, question 28 (Q-28) on financial difficulties, and questions 29-30 measuring global health status/quality of life (HR-QOL). The study had 80% power to detect a 0.20 correlation coefficient (r) between anchors and PROFFIT-score (items 1-7, range 0-100, 100 indicating maximum FT) with bilateral alpha 0.05 and 80% power. Confirmatory factor analysis was conducted. FT determinants (items 8-16) were described.
RESULTS RESULTS
Median age of patients was 65 years, 116 (52.5%) were females, 96 (43.4%) had low education level. Confirmatory factor analysis confirmed goodness of fit of the PROFFIT-score. Significant partial correlation of PROFFIT-score was found with Q-28 (r = 0.51) and HR-QOL (r = -0.23). Mean (SD) PROFFIT-score at baseline was 36.5 (24.9); it was statistically significantly higher for patients living in South Italy, those with lower education level, those who were freelancer/unemployed at diagnosis and those who reported significant economic impact from the COVID-19 pandemic. Mean (SD) scores of determinants ranged from 17.6 (27.1) for item 14 (support from medical staff) to 49.0 (36.3) for item 10 (expenses for medicines or supplements). PROFFIT-score significantly increased with worsening response to determinants.
CONCLUSIONS CONCLUSIONS
External validation of PROFFIT-score in an independent sample of patients was successful. The instrument is now being used in clinical studies.

Identifiants

pubmed: 38052104
pii: S2059-7029(23)01433-3
doi: 10.1016/j.esmoop.2023.102192
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

102192

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

L Arenare (L)

Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.

C Porta (C)

Interdisciplinary Department of Medicine, Università degli Studi 'A. Moro', Bari, Italy; Polyclinic Consortium University Hospital, Bari, Italy.

D Barberio (D)

Departmental Structure of Clinical Psycho-oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.

S Terzolo (S)

Department of Oncology, Università di Torino, AO Ordine Mauriziano, Torino, Italy.

V Zagonel (V)

Oncology Unit 1, Istituto Oncologico Veneto, IOV, IRCCS, Padova, Italy.

S Pisconti (S)

Oncology Unit, Ospedale S. G. Moscati, Statte TA, Italy.

L Del Mastro (L)

Medical Oncology, IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Internal Medicine and Medical Specialties (DIMI), Università di Genova, Genova, Italy.

C Pinto (C)

Medical Oncology, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

D Bilancia (D)

Medical Oncology, Azienda Ospedaliera San Carlo, Potenza, Italy.

S Cinieri (S)

Medical Oncologiy, Ospedale Perrino, Brindisi, Italy.

M Rizzo (M)

Polyclinic Consortium University Hospital, Bari, Italy.

G Migliaccio (G)

Departmental Structure of Clinical Psycho-oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.

V Montesarchio (V)

Medical Oncology, Azienda Ospedaliera Specialistica dei Colli, Napoli, Italy.

L Del Campo (L)

Federazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Rome, Italy.

F De Lorenzo (F)

Federazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Rome, Italy; European Cancer Patient Coalition (ECPC), Brussels, Italy.

E Iannelli (E)

Federazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Rome, Italy; Associazione Italiana Malati di Cancro (AIMAC), Roma, Italy.

F Traclò (F)

Associazione Italiana Malati di Cancro (AIMAC), Roma, Italy.

L Gitto (L)

Department of Economy, Università degli Studi di Messina, Messina, Italy.

M C Vaccaro (MC)

Welfare and Health Department, Centro Studi Investimenti Sociali (CENSIS), Roma, Italy.

L Frontini (L)

Federation of Italian Cooperative Oncology Groups (FICOG), Milano, Italy.

D Giannarelli (D)

Epidemiology and Biostatistics, GSTeP, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.

J Bryce (J)

Ascension St. John Clinical Research Institute, Tulsa, USA.

M C Piccirillo (MC)

Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.

C Jommi (C)

Department of Pharmaceutical Sciences, Università del Piemonte Orientale, Novara, Italy.

F Efficace (F)

Gruppo Italiano per le Malattie Ematologiche dell'Adulto (GIMEMA) Health Outcomes Research Unit, Roma, Italy.

S Riva (S)

St Mary's University, Twickenham, London, UK.

M Di Maio (M)

Department of Oncology, Università di Torino, AO Ordine Mauriziano, Torino, Italy.

C Gallo (C)

Professor Emeritus Medical Statistics, Università degli Studi della Campania 'Luigi Vanvitelli', Napoli, Italy.

F Perrone (F)

Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy. Electronic address: f.perrone@istitutotumori.na.it.

Classifications MeSH