Financial burden in early-stage breast cancer
Official title: Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer
Run by National Cancer Institute, Naples · NCT07354165 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 864 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | September 2030 |
| Study ends | September 2034 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07354165 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
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.