txt4AML: An Innovative Mobile Intervention to Improve Oral Anti-Cancer Medications Among Acute Myeloid Leukemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Real-time oral anticancer medication (OAM) medication adherence
研究概览
简要总结
This clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication reminders works to improve adherence to oral anti-cancer medications among patients with acute myeloid leukemia (AML). Medication adherence is how well patients take medications as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a barrier to effective treatment. Collecting feedback on patient experiences using the mobile intervention may help doctors design new methods and material for providing educational information to AML patients who are taking oral anti-cancer medications.
详细描述
PRIMARY OBJECTIVE:
I. To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.
SECONDARY OBJECTIVE:
I. To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with acute myeloid leukemia (AML)
- •Patients will be or is taking venetoclax (or any other oral anticancer medication) as part of their first line therapy
- •Has a phone with text capabilities
- •Among patients aged 18 and older we will enroll participants regardless of race or ethnicity
排除标准
- •Individuals who are terminally ill (defined as having less than 2 months to live)
- •Individuals for whom there is documentation of inability to provide consent in the medical record
- •Do not speak/read English
- •This study will exclude pediatric patients (defined as individuals under age 18 years)
结局指标
主要结局
Real-time oral anticancer medication (OAM) medication adherence
时间窗: At 2 months
Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals.
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
时间窗: At 2 months
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
次要结局
- Incomplete blood count recovery (Cri)(At baseline, 1, and 2 months)
- Partial remissions (PR)(At baseline, 1, and 2 months)
- Complete remission (CR)(At baseline, 1, and 2 months)
- Morphologic leukemia-free state (MLFS)(At baseline, 1, and 2 months)