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

Recruiting

• Conditions: Cancer

• Registration Number: NCT03473379
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-02-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Azienda dei Colli; 🇮🇹 Napoli, Italy

Istituto Nazionale Tumori, IRCCS Fondazione Pascale; 🇮🇹 Napoli, Italy

Istituto Nazionale Tumori Regina Elena - IRCCS - IFO; 🇮🇹 Roma, Italy

Policlinico Universitario Campus Biomedico; 🇮🇹 Roma, Italy

AO Ordine Mauriziano; 🇮🇹 Torino, Italy