Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile
研究概览
简要总结
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:
- before to start the chemotherapy
- during chemotherapy
- after the end of chemotherapy
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile
时间窗: 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
时间窗: 1 week
Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios
次要结局
- Regret and disappointment assessment(1 week)
- Behavior assessment(1 week)
- Reaction to uncertain situations assessment(1 week)