RecruitingNCT07354165

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


Sponsor

National Cancer Institute, Naples

Enrollment

864 participants

Start Date

Sep 30, 2025

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • 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 Criteria3

  • Stage IV invasive breast carcinoma
  • Major cognitive dysfunction or psychiatric disorders
  • Any previous systemic treatment for the current breast cancer

Interventions

OTHERQuestionnaires

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


Locations(1)

National Cancer Institute of Napoli

Napoli, Italy

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NCT07354165


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