Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- physical activity (daily steps)
研究概览
简要总结
A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.
详细描述
- Baseline measurement (n=200): screening and enrollment
- 3-month visit: collecting MEMS data
- 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.
- 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data
- 18-month visit: collecting MEMS data and interview
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 0-III breast cancer
- •Treated with Adjuvant hormonal therapy
排除标准
- •Stage IV breast cancer
- •Breast cancer recurrence or metastasis
- •Severe medical illness
研究组 & 干预措施
high adherence control group
-Patients on continuous MEMS monitoring with usual care.
low adherence control group
-Patients on continuous MEMS monitoring with usual care.
low adherence intervention group
- Patient with the WALKON mobile application.
- Patient with monthly feedback call
- Patients on continuous MEMS monitoring.
干预措施: low adherence intervention group (Behavioral)
结局指标
主要结局
physical activity (daily steps)
时间窗: 12 months
Comparison of daily steps using WALKON application
次要结局
- Medication adherence using MEMS device(18 months)
研究者
Yul Ha Min
Assistant professor
Gachon University