NCT00769080已完成不适用
A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- compare the 1-year adherence
研究概览
简要总结
The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated written Informed Consent
- •Have been taking upfront AI adjuvant therapy in line with current SmPC
- •Be capable of completing drug intake by herself
- •Be capable of understanding Chinese
排除标准
- •Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
- •Upfront adjuvant AI medication which has exceeded over eight weeks
- •Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
- •Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
结局指标
主要结局
compare the 1-year adherence
时间窗: 1 year
次要结局
- scores of Beliefs about Medicines Questionnaire (BMQ)(1 year)
- Scores in Patient Centred Care Questionnaire (PCCQ)(1 year)
- Morisky scale(1 year)
研究者
研究点 (1)
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