Financial Toxicity in Patients With Early-stage Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Financial Toxicity at one year — baseline visit (before surgery or chemotherapy/endocrine therapy depending on the cohort), at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires
  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

Trial sites (1)

More National Cancer Institute, Naples trials in Italy

Other trials for the same condition