Implementation Strategies for Monitoring Adherence in Real Time
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The objective of this project is to identify effective strategies to help patients with lung cancer manage side effects and achieve optimal adherence to oral targeted therapies. To achieve this objective, we will evaluate the effect of a novel, bidirectional conversational agent, compared to usual care, on adherence to oral targeted therapies using a two-arm randomized controlled trial, and explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from clinicians and patients.
详细描述
Drawing from insights in behavioral economics and implementation science, the goal of our project is to identify effective strategies for improving lung cancer outcomes by helping patients to better manage symptoms and adhere to oral therapies. Given the rapid increase in FDA-approved targeted therapies, the need for such strategies will continue to grow. Our central hypothesis is that conversational agent will improve adherence to oral therapies by targeting patient-level determinants of behavior change. The specific aims are to: 1) Test the effects of a patient-directed intervention (conversational agent) to improve adherence to oral targeted therapies in patients with non-small cell lung cancer.; and 2) Use mixed-methods approaches with clinicians and patients to explore multilevel factors shaping the acceptability, effectiveness, and future implementation of intervention into routine cancer care. Primary trial outcomes (adherence and persistence) will be measured using microelectronic monitoring system (MEMS) caps. Secondary outcomes will be assessed using longitudinal surveys and medical record data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and their care providers (including investigators) will not be blinded. The primary analyst and outcomes assessor will be blinded. Blinding may be broken in an emergency.
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
- •Adult patient (age > 18 years) with NSCLC at UPHS who is receiving one of the following nine oral therapies: afatinib, erlotinib, dacomitinib, gefitinib, osimertinib, alectinib, brigatinib, crizotinib, or lorlatinib.
- •Patient possession of a mobile device that can send/receive SMS texts
- •Ability to respond to questions and engage with "Penny" in English
- •Ability to provide informed consent to participate in the study
- •Approval from the patient's medical oncologist to be approached
排除标准
- •Inability to respond to questions and engage with "Penny" in English
- •Inability or unwillingness to provide informed consent to participate in the study
- •Inability to engage with SMS text-messaging platform
- •Concurrent enrollment in a therapeutic clinical trial
- •Taking more than one oral targeted therapy or concurrent chemotherapy during the study window
- •Lack of approval from the patient's oncologist
研究组 & 干预措施
Intervention Arm
Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.
干预措施: Conversational Agent/Chatbot (Device)
Control Arm
Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.
干预措施: Usual Care (Other)
结局指标
主要结局
Adherence
时间窗: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Defined as number of patients who have 95% or greater adherent days across the study period based on their prescribed dose. Adherence data will be assessed via MEMS caps, which capture a date and time stamp each time the pill bottle is opened.
次要结局
- Persistence(12 weeks after study initiation or at therapy discontinuation, whichever is shorter)
研究者
Katharine Rendle
Assistant Professor
University of Pennsylvania