Financial Toxicity in Patients With Early-stage Breast Cancer (VOICE - GIM36)

National Cancer Institute, Naples

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT07354165

VOICE - GIM36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 864 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

864 participants in 8 patient groups

Cohort 1

Description:

patients that received surgery without any further anticancer treatment

Treatment:

Other: Questionnaires

Cohort 2

Description:

patients that received surgery followed by adjuvant chemotherapy only

Treatment:

Other: Questionnaires

Cohort 3

Description:

patients that received surgery followed by chemotherapy and endocrine therapy

Treatment:

Other: Questionnaires

Cohort 4

Description:

patients that received surgery followed by endocrine therapy

Treatment:

Other: Questionnaires

Cohort 5

Description:

patients that received neoadjuvant chemotherapy followed by surgery and no further treatment

Treatment:

Other: Questionnaires

Cohort 6

Description:

patients that received neoadjuvant chemotherapy followed by surgery and adjuvant chemotherapy

Treatment:

Other: Questionnaires

Cohort 7

Description:

patients that received neoadjuvant chemotherapy followed by surgery and adjuvant endocrine therapy

Treatment:

Other: Questionnaires

Cohort 8

Description:

patients that received neoadjuvant endocrine therapy followed by surgery and adjuvant endocrine therapy

Treatment:

Other: Questionnaires