PROACTYVE Pilot:Pilot Study of Patient's Adherence to TYKERB™/TYVERB™+Capecitabine in Metastatic Breast Cancer-Observation of Patient Adherence and Evaluation of Predictive Factors for Patient Adherence After Providing Educational Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Patient knowledge, attitude and beliefs about the regimen
研究概览
简要总结
This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients
详细描述
Approximately 60 subjects with HER2+ metastatic or advanced breast cancer who meet the inclusion/exclusion criteria will be enrolled into the study. All subjects will receive education intervention for 6 weeks including education on Day 0, follow-up phone calls on Day 1 and Day 7, reminder phone calls before Week 3 and 6 visit and telephone hot line number.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Signed written informed consent;
- •Female outpatient aged 18 years or older;
- •Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information
- •Subjects must be literate, be able to read, understand and write local language.
排除标准
- •Women who is participating in any other interventional clinical trials concurrently;
- •Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
- •Primary lesions that are not of breast origin.
结局指标
主要结局
Patient knowledge, attitude and beliefs about the regimen
时间窗: Day 0, Week 3 and Week 6
Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes
Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6
时间窗: week 3 & 6
Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes
Subject recruitment and retention in the study
时间窗: upto week 6
Assess the feasibility of recruitment and retention of subjects into the education program
Acceptability of study procedures and educational materials at Week 6
时间窗: week 6
Evaluate the implementation and acceptability of the education materials and study procedures
次要结局
- Serious adverse events and adverse events up to 6 weeks(upto week 6)