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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06332976
Other study ID # IEO 1521
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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