PrefeRences And ChemoTherapy In Breast Cancer patiEnts

Recruiting

• Conditions: Female Breast Cancer
• Interventions: Other: Completion of questionnaires

• Registration Number: NCT06332976
• Lead Sponsor: European Institute of Oncology

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-06-04
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
During chemotherapy	Completion of questionnaires	Women who are receiving chemotherapy at the time of informed consent (interview within 1 year from beginning of CT)
Before chemotherapy start	Completion of questionnaires	Women candidate to adjuvant or neoadjuvant chemotherapy for breast cancer at the time of informed consent (interview before the start of CT)
After chemotherapy end	Completion of questionnaires	Women who already received chemotherapy at the time of informed consent (interview after more than 4 years of CT end)

Primary Outcome Measures

Name	Time	Method
Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile	1 week	Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios
Prolonged survival time gain needed to consider CT worthwhile	1 week	Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios

Secondary Outcome Measures

Name	Time	Method
Regret and disappointment assessment	1 week	Collection of Regret and Disappointment Scale (RDS) questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a greater agreement with the statement)
Behavior assessment	1 week	Collection of CONOR questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement)
Reaction to uncertain situations assessment	1 week	Collection of Intolerance of Uncertainty Scale Short-Form (IUS-12) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy