NCT04228432已完成不适用
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Rate of patients who do not fail the E-Monitoring protocol
研究概览
简要总结
This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .
45 patients will be included.
Patients will be followed during 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
- •Patient equipped with a computer or tablet computer and an internet connection at home
- •Age > 18 years old
- •Patient affiliated to the french social security system
- •Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
- •Women of childbearing age should have effective contraception under hormonotherapy
排除标准
- •Patient with breast cancer who does not require adjuvant hormonotherapy
- •Patient with metastatic breast cancer
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- •Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
- •Patient protected by law.
结局指标
主要结局
Rate of patients who do not fail the E-Monitoring protocol
时间窗: 6 months per patient
次要结局
- Number of medical consultations required over 6 months(6 months per patient)
- Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire(6 months per patient)
研究者
研究点 (1)
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