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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1: concept elicitation and coding<br>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<br>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<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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economic difficulty, financial toxicity