Questionnaires: The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16); EORTC QLQ-C30 questionnaire (items 29-30) and OV28 (items 55-58); PRO-CTCAE: short list of 43 symptoms relevant for ovarian cancer
Study 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.
Eligibility
Sex
FEMALE
Min age
—
Max age
—
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).
Primary outcome measure(s)
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 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).
Trial sites (1)
Facility
City
Region
Status
Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department
Naples
Italy
Recruiting
More National Cancer Institute, Naples trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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