Female Breast Cancer
Conditions
Keywords
Early breast cancer, Locally advanced breast cancer
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.
Interventions
Completion of questionnaires at the time of study entry
Sponsors
European Institute of Oncology
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Italy
Contacts
Primary ContactEmilia Montagna, MD
Outcome results
None listed