Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Number of comments from participants indicating ease of use of the application.
研究概览
简要总结
The purpose of this study is to develop an on-line electronic symptom management application that can ultimately be used to improve clinical outcomes in patients with mRCC treated with cabozantinib.
详细描述
This is a single-site, prospective technology-based, clinical trial. Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria will be enrolled in this study. Subjects will be given an iPOD touch with the symptom monitoring application installed, physical activity and blood pressure monitors. Each patient will be kept on study for the first 12 weeks of therapy with cabozantinib. Subjects on treatment for less than 12 weeks will not be replaced.The symptoms and other data (physical activity, blood pressure) recorded electronically by the patient will be compared to symptoms recorded in the medical record at interval clinic visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age Patients planning to start treatment with cabozantinib therapy for renal cancer.
- •Technology requirement: The patient will need to have home wireless internet access for use of the software and technology in this study. The patient will need to already have or be willing to set up a Duke MyChart account.
排除标准
- •Non-English Speaking. Any patient who is not able to comprehend and operate the technology at the discretion of the enrolling provider.
结局指标
主要结局
Number of comments from participants indicating ease of use of the application.
时间窗: 12 weeks
Number of comments from participants indicating ease of use of the application.
次要结局
- Movement recorded daily by the activity tracking device compared with ECOG assessment outcomes measured during interval clinic visits within the first 12 weeks to determine similar estimates of activity.(12 weeks)
- Number and frequency of adverse symptoms reported in the symptom management application compared with clinical assessment of adverse events recorded at interval clinic visits within the first 12 weeks to determine similar report of adverse symptoms.(12 weeks)
- Blood pressure (BP) readings measured daily by the BP monitoring device compared with those BP readings measured at interval clinic visits within the first 12 weeks to determine similar detection of symptoms.(12 weeks)