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

Cancer Clinical Trial

— PROFTC-I  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03473379
• Other study ID #: PROFTC-I
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: Francesco Perrone
• Phone: 0815903571
• Email: f.perrone[@]istitutotumori.na.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: July 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cancer
• Financial Stress

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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