PrefeRences And ChemoTherapy In Breast Cancer patiEnts (PRACTICE)

European Institute of Oncology

Status: Enrolling

Conditions: Female Breast Cancer

Treatments: Other: Completion of questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06332976

IEO 1521

Details and patient eligibility

About

The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.

The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:

1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy

Full description

The chemotherapy is generally proposed a large number of early breast cancer patients to reduce the risk of recurrence and death. However chemotherapy is associated with side effects that impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients. The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with early or locally advanced breast cancer
• Patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy
• Sufficient literacy in Italian to complete the questionnaires
• Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent

Exclusion criteria

• None

Trial design

450 participants in 3 patient groups

Before chemotherapy start

Description:

Women candidate to adjuvant or neoadjuvant chemotherapy for breast cancer at the time of informed consent (interview before the start of CT)

Treatment:

Other: Completion of questionnaires

During chemotherapy

Description:

Women who are receiving chemotherapy at the time of informed consent (interview within 1 year from beginning of CT)

Treatment:

Other: Completion of questionnaires

After chemotherapy end

Description:

Women who already received chemotherapy at the time of informed consent (interview after more than 4 years of CT end)

Treatment:

Other: Completion of questionnaires