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

National Cancer Institute, Naples

Status: Enrolling

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03473379

PROFTC-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

440 participants in 4 patient groups

Phase 1: concept elicitation and coding

Description:

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

Description:

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

Description:

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

Description:

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