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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03473379
Other study ID # PROFTC-I
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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