Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- eMedonline will be used to measure non-compliance in taking oral drug regimens.
研究概览
简要总结
This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.
详细描述
This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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 or older.
- •Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate
- •Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily
- •Known performance status 0,1 or 2 (ECOG)
- •Known adequate end organ function, defined as:
- •Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN ANC > 1.5 Platlets > 100,000
- •Patient is willing and able to use a cell phone
- •Written, voluntary informed consent
排除标准
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
研究组 & 干预措施
eMedonline access
patients will be followed for 3 months with access to eMedonline
干预措施: eMedonline access (Behavioral)
no access to eMedonline
patients will be followed for 3 months with no access to eMedonline
干预措施: no access to eMedonline (Behavioral)
结局指标
主要结局
eMedonline will be used to measure non-compliance in taking oral drug regimens.
时间窗: at 6 months, non-compliance will be measured in each arm of study
Patients are stratified to one of two groups: Group 1 is pateints on Gleevec or Tasigna who have been on drug less than 6 months; Group 2 is patients on Gleevec or Tasigna who have been on drug for equal to or more than 6 months. Group 1 is then divided into 2 groups: one using eMedonline for 3 months and the other not using eMedonline for 3 months. A crossover survey and pill counts will be done at the 3 month timepoint and then the groups will switch their access status to eMedonline.
次要结局
未报告次要终点