Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Financial Toxicity "PROFFIT financial score"
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Financial Toxicity "PROFFIT financial score"
Time Frame: 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
PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485).
Secondary Outcomes
- Financial toxicity "Determinants"(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.)
- Changes of 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)
- Quality of Life (QoL)(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)