Financial burden in early-stage breast cancer
Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer
This project will see if people with early-stage breast cancer experience meaningful financial hardship during the first year of treatment using the PROFFIT questionnaire.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 864 (estimated) |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT07354165 on ClinicalTrials.gov |
What this trial studies
Researchers will prospectively follow adults with stage I–III invasive breast cancer who have not yet started systemic therapy to measure financial toxicity over time. The Italian PROFFIT questionnaire (16 items, 7-item financial score) will be used at baseline and one year after the start of first oncological treatment. The primary outcome is the proportion of patients with a clinically significant worsening (≥18-point change) in the PROFFIT financial score at one year, and secondary aims include links with quality of life, disease-free survival, overall survival, and changes in determinant weights over time. Enrollment is centered at the National Cancer Institute of Naples and excludes patients with stage IV disease, prior systemic therapy for the current cancer, or major cognitive/psychiatric disorders.
Who should consider this trial
Good fit: Adults over 18 with newly diagnosed, histologically confirmed stage I–III invasive breast cancer who have not started any systemic treatment and can provide informed consent.
Not a fit: Patients with metastatic (stage IV) disease, those who have already received systemic therapy for the current cancer, or those with major cognitive or psychiatric impairments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could clarify how common and severe financial toxicity is for Italian early breast cancer patients and inform interventions or policies to reduce financial hardship.
How similar studies have performed: International studies have shown that cancer-related financial toxicity is common and linked to lower quality of life, while applying the PROFFIT instrument specifically in Italian early breast cancer patients is a relatively new, localized approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent form * Age \> 18 years at the time of study entry * Histologically confirmed stage I-III invasive breast carcinoma before starting any systemic treatment. Exclusion Criteria: * Stage IV invasive breast carcinoma * Major cognitive dysfunction or psychiatric disorders * Any previous systemic treatment for the current breast cancer
Where this trial is running
Naples
- National Cancer Institute of Napoli — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Carmela Piccirillo, MD — National Cancer Institute, Naples
- Study coordinator: Maria Lucia Iacovino, MD
- Email: marialucia.iacovino@istitutotumori.na.it
- Phone: +3908117770692
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.