THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Medication adherence
研究概览
简要总结
This clinical trial evaluates the feasibility and acceptability of a mobile health device in improving oral chemotherapy adherence in women with triple negative breast cancer that has not spread to other places in the body (non-metastatic). A mobile health device, called SMRxT smart pill bottle may help doctors to remind patients to take medicine on time and monitor their symptoms.
详细描述
PRIMARY OBJECTIVES:
I. Feasibility. II. Acceptability. III. Capecitabine/Xeloda adherence.
EXPLORATORY OBJECTIVES:
I. Symptom burden. II. Patent physician communication. III. Quality of life. IV. Self-efficacy for managing symptoms.
OUTLINE: Patients are randomized to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18 years
- •Breast cancer
- •English speaking
- •New or existing prescription for capecitabine/Xeloda
- •Willingness and ability of the subject to comply with study procedures
- •Have a mobile phone with text message
- •Evidence of an online informed consent indicating that the subject is aware of the risk and benefits of study participation
排除标准
- •Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment
- •Eastern Cooperative Oncology Group (ECOG) performance status > 2
研究组 & 干预措施
Group I (SMRxT smart pill bottle)
Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles.
干预措施: Informational Intervention (Other)
Group I (SMRxT smart pill bottle)
Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles.
干预措施: Medical Device Usage and Evaluation (Other)
Group I (SMRxT smart pill bottle)
Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles.
干预措施: Quality-of-Life Assessment (Other)
Group I (SMRxT smart pill bottle)
Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles.
干预措施: Survey Administration (Other)
Group II (standard of care)
Patients receive a SMRxT smart pill bottle and standard of care.
干预措施: Best Practice (Other)
Group II (standard of care)
Patients receive a SMRxT smart pill bottle and standard of care.
干预措施: Quality-of-Life Assessment (Other)
Group II (standard of care)
Patients receive a SMRxT smart pill bottle and standard of care.
干预措施: Survey Administration (Other)
结局指标
主要结局
Medication adherence
时间窗: From baseline up to 90 days
Proportion of times each patient took her scheduled medication during the 3-month study. For each patient, will operationalize adherence as the number of times that the pill monitor recorded a dose taken for each day that the patient was in the study and supposed to take the pill. Days during which patients were off cycle, advised by their provider to temporarily stop the medication, or hospitalized will be deducted from the total days in the study.
次要结局
- Acceptability(From baseline up to 90 days)
- End-user engagement by patients and their oncology team(From baseline up to 90 days)
研究者
Ilana Graetz
Principal Investigator
Emory University