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Brief Title: PRO for Fighting FT in Ovarian Cancer
Official Title: Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer
Study ID: NCT06032975
Brief Summary: 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.
Detailed 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department, Naples, , Italy
Name: Sandro Pignata, MD, PhD
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR