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.
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
440
Azienda dei Colli
Napoli, Italy
RECRUITINGIstituto Nazionale Tumori, IRCCS Fondazione Pascale
Napoli, Italy
RECRUITINGIstituto Nazionale Tumori Regina Elena - IRCCS - IFO
Roma, Italy
RECRUITINGValidation 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.
Time frame: 48 months
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Policlinico Universitario Campus Biomedico
Roma, Italy
NOT_YET_RECRUITINGAO Ordine Mauriziano
Torino, Italy
RECRUITING