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

Conditions

Cancer

Keywords

economic difficulty, financial toxicity

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.

Silvia Riva, Laura Arenare, Massimo Di Maïo, Fabio Efficace, Vincenzo Montesarchio et al. (27 authors)

BMJ Open2021-10-0137 citations

10.1136/bmjopen-2021-049128

A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system.

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, Traclò F, Vaccaro CM, Arenare L, Canzanella G, Gimigliano A, Romano F, Savio A, Sparavigna L, Piccirillo MC, Guizzaro L, Gallo C, Perrone F.

2020-10-2214 citations

10.1007/s00520-020-05840-z

Measuring financial toxicity of cancer in the Italian health care system: Initial results of the patient reported outcome for fighting financial toxicity of cancer project (proFFiT).

Jane Bryce, Silvia Riva, Massimo Di Maïo, Fabio Efficace, Luciano Frontini et al. (18 authors)

Journal of Clinical Oncology2019-09-204 citations

10.1200/jco.2019.37.27_suppl.91

Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol

Silvia Riva, Jane Bryce, Francesco De Lorenzo, Laura Del Campo, Massimo Di Maïo et al. (16 authors)

BMJ Open2019-09-0123 citations

10.1136/bmjopen-2019-031485

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Validation of Patient reported outcome financial toxicity of cancer Italian(PROFTC-I) questionnaire	48 months	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.

Countries

Italy

Contacts

Primary ContactFrancesco Perrone

f.perrone@istitutotumori.na.it0815903571

Backup ContactJane Bryce

j.bryce@istitutotumori.na.it0815903571

Outcome results