PRO for Fighting FT in Ovarian Cancer (MITO45-ProFFiT)

National Cancer Institute, Naples

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06032975

MITO 45-ProFFiT

Details and patient eligibility

About

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for OC patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.

Full description

PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT.The primary aim of the study is to compare PROFFIT financial score (items 1-7 measuring the financial distress) across different lines of treatment for OC patients undergoing anticancer medical treatment. Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline, before starting each line of treatment.

In addition, among secondary aims of this study, we aim to verify whether FT is associated with quality of life response (items 29-30 of the EORTC QLQ-C30 questionnaire and items 55-56 of the EORTC QLQ-OV28 questionnaire), with patient-self reporting toxicity of treatments (selected symptoms of the PRO-CTCAE library response), and with overall survival.

Enrollment: 240 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent provided;
• Women ≥18 years;
• Histologically or citologically confirmed diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer stage IC-IV according to FIGO staging system;
• Patients who are close to begin any type of medical treatment against ovarian cancer.

Exclusion criteria

• Major cognitive dysfunction or psychiatric disorders;
• Patients with epithelial ovarian, fallopian tube or peritoneal cancer candidate exclusively to follow-up;
• Patients who have received more than 4 previous lines of medical treatment (maintenance treatments do not represent a line).

Trial design

240 participants in 4 patient groups

Cohort 1:

Description:

Patients undergoing their first medical treatment for OC (including adjuvant and neo-adjuvant chemotherapy and first-line treatment for advanced in patients not previously treated with adjuvant chemotherapy)

Treatment:

Other: Questionnaires

Cohort 2

Description:

Patients undergoing their second medical treatment for OC (including the second-line treatment for advanced disease and the first-line treatment for advanced disease in patients previously treated with adjuvant CT)

Treatment:

Other: Questionnaires

Cohort 3

Description:

Patients undergoing their third medical treatment for OC (including the third-line treatment for advanced disease and the second-line treatment for advanced disease in patients previously treated with adjuvant CT)

Treatment:

Other: Questionnaires

Cohort 4

Description:

Patients undergoing their fourth medical treatment for OC (including the fourth- treatment for advanced disease and the third-line treatment for advanced disease in patients previously treated with adjuvant CT)

Treatment:

Other: Questionnaires