Evaluating financial distress in ovarian cancer treatment
Official title: Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer
Run by National Cancer Institute, Naples · NCT06032975 · Data updated 2026-11-12
This study is trying to see how different treatment plans for ovarian cancer affect the financial stress that patients experience over time.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | October 30, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | November 13, 2023 |
| Trial ID | NCT06032975 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with confirmed advanced-stage ovarian, fallopian tube, or peritoneal cancer who are about to begin medical treatment.
✕Probably not a fit
Patients with major cognitive dysfunction, psychiatric disorders, or those not receiving active treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the impact of a treatment algorithm on financial toxicity experienced by ovarian cancer patients over time. Utilizing the PROFFIT questionnaire, which measures financial distress and its determinants, the study will compare financial scores across different treatment lines. Additionally, it will explore the relationship between financial toxicity, quality of life, treatment-related symptoms, and overall survival. The study is conducted in a multicenter setting within the Italian healthcare context.
Why it matters
Potential benefit: If successful, this study could provide insights into managing financial distress in ovarian cancer patients, potentially improving their quality of life.
How similar studies have gone: While studies on financial toxicity in cancer care are emerging, this specific approach using the PROFFIT questionnaire in ovarian cancer is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department
Naples, Italy Recruiting
Study contacts
- Principal investigator: Sandro Pignata, MD, PhD — National Cancer Institute, Naples
- Study coordinator: Clorinda Schettino, MD
- Email: c.schettino@istitutotumori.na.it
- Phone: +39 081 - 17770276
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.