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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before chemotherapy start | Women candidate to adjuvant or neoadjuvant chemotherapy for breast cancer at the time of informed consent (interview before the start of CT) |
| |
| During chemotherapy | Women who are receiving chemotherapy at the time of informed consent (interview within 1 year from beginning of CT) |
| |
| After chemotherapy end | Women who already received chemotherapy at the time of informed consent (interview after more than 4 years of CT end) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Completion of questionnaires | Other | Completion of questionnaires at the time of study entry |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior assessment | Collection of CONOR questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement) | 1 week |
| Reaction to uncertain situations assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients candidate to or who are receiving/have already redceived adjuvant or neoadjuvant chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilia Montagna, MD | Contact | +390257489970 | emilia.montagna@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Emilia Montagna, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |