Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Percentage of risk reduction needed to consider endocrine therapy worthwhile
研究概览
简要总结
Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.
They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.
Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.
Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.
详细描述
The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.
In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may 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 and the prolongation of the treatment.
Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Women candidate to adjuvant hormonal therapy for breast cancer before the start of therapy
- •Women who are receiving hormonal therapy (within 1 year from beginning)
- •Women who are receiving hormonal therapy (who had receive at least 4 or 5 or 6 years of hormonal therapy)
- •Patients who underwent to radical surgery for breast cancer
- •Patients who have received neoadjuvant or adjuvant chemotherapy are also eligible
- •Hormonal receptors positive breast cancer (ER and or PgR >1%)
- •Sufficient literacy in Italian to complete the questionnaires.
排除标准
- •Patients who had received at least 1 year and no more than 3 years of hormonal therapy
- •Patients who are receiving hormonal therapy (who had receive 7 years or more of hormonal therapy)
结局指标
主要结局
Percentage of risk reduction needed to consider endocrine therapy worthwhile
时间窗: 1 week
Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios
Number of years gain needed to consider ET 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
未报告次要终点