Evaluating financial distress in ovarian cancer treatment
Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer
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 |
|---|---|
| Enrollment | 240 (estimated) |
| Sex | Female |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06032975 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with major cognitive dysfunction, psychiatric disorders, or those not receiving active treatment may not benefit from this study.
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 performed: While studies on financial toxicity in cancer care are emerging, this specific approach using the PROFFIT questionnaire in ovarian cancer is relatively novel.
Eligibility criteria
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 this trial is running
Naples
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.