PrefeRences And ChemoTherapy In Breast Cancer patiEnts

Female Breast Cancer Clinical Trial

— PRACTICE  

Official title:

Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332976
• Other study ID #: IEO 1521
• Status: Recruiting
• Start date: June 4, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Emilia Montagna, MD
• Phone: +390257489970
• Email: emilia.montagna[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer

Intervention

Other:
• Completion of questionnaires
Completion of questionnaires at the time of study entry

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile	Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios	1 week
Primary	Prolonged survival time gain needed to consider CT worthwhile	Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios	1 week
Secondary	Behavior assessment	Collection of CONOR questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement)	1 week
Secondary	Reaction to uncertain situations assessment	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)	1 week
Secondary	Regret and disappointment assessment	Collection of Regret and Disappointment Scale (RDS) questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a greater agreement with the statement)	1 week