NCT07354165

Financial Toxicity in Patients With Early-stage Breast Cancer

Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 864 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for early-stage breast cancer 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.

Detailed description

PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. Primary aim of this study is to describe the rate of patients with early breast cancer experiencing financial toxicity (defined as a change of ≥18 points in the PROFFIT-score \[items 1-7\]) one year after the beginning of the first oncological treatment. In addition, among secondary aims of this study, we aim to verify whether FT is associated with quality of life response , and with disease free survival and overall survival.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	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, EORTC QLQ-BR42 and HADS questionnaires are currently used in clinical practice

Timeline

• Start date: 2025-09-30
• Primary completion: 2030-09-01
• Completion: 2034-09-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: Italy