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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details

Cancer

NCT03473379

National Cancer Institute, Naples

25 January 2024

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