PRO for Fighting FT in Ovarian Cancer

NCT06032975 · National Cancer Institute, Naples

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title

Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer

About this study

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.

Eligibility criteria

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).

Study design

Enrollment target: 240 participants

Age groups: child, adult, older_adult

Timeline

Starts: 2023-10-30

Estimated completion: 2027-09-01

Last updated: 2023-11-13

Interventions

Other: Questionnaires

Primary outcomes

• Financial Toxicity "PROFFIT financial score" (baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months)

Sponsor

National Cancer Institute, Naples · other

Contacts & investigators

ContactClorinda Schettino, MD · contact · c.schettino@istitutotumori.na.it · +39 081 - 17770276

ContactPiera Gargiulo, MD · contact · piera.gargiulo@istitutotumori.na.it · +39 081 - 17770276

InvestigatorSandro Pignata, MD, PhD · principal_investigator, National Cancer Institute, Naples

All locations (1)

Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology DepartmentRecruiting

Naples, Italy

View on ClinicalTrials.gov ↗Find similar trials