Embodied Conversational Agent (ECA) as an Oncology Trial Advisor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- treatment protocol adherence
研究概览
简要总结
The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates. The Study Buddy will use the web-based ECA infrastructure developed for use on another project. We will use web browsers on tablets provided to study participants to access the Study Buddy, providing anywhere, anytime access to its functions. Usability metrics will include session time, satisfaction, and error rates.
详细描述
Subjects will be identified from among patients on chemotherapy regimens at BMC. With the provider's approval, we will recruit patients for this study.
All subjects will be enrolled for 2 months. After consent, we will collect baseline data. Baseline data is collected after enrollment and before randomization. Baseline data includes:
sociodemographic data PROMIS Mental and Social health the PHQ-9 clinical factors such as medical diagnosis (cancer type and stage) the Short Assessment of Health Literacy-English the Short Portable Mental Status Questionnaire (SPMSQ) for cognitive impairment the Need For Cognition scale contact numbers of two friends or family members who will assist us in establishing contact, if necessary.
The exit interview will be conducted 2 months after the baseline interview, with windows of 2 weeks plus or minus that date. Study staff will attempt to coincide this interview with a clinical visit, to minimize inconvenience for the subject.
Data collected at the exit interview will include:
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
- 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
- •speaks English fluently
- •is able to independently consent into this study and parent cancer study
- •has adequate corrected vision to use the ECA system (based on a 1-minute functional screener)
- •has adequate hearing to use the ECA system
排除标准
- •suicidal or homicidal
- •currently in police custody
- •do not live in the Boston area
- •plan on leaving the Boston area for more than 4 weeks in the next 6 months
- •score 6 or less on the SPMSQ screening test
研究组 & 干预措施
Control
Standard of care for chemotherapy treatment.
Chemo Buddy
Subject receives instructions on how to use the personalized touch screen tablet and takes it home for 2 months.
干预措施: Chemo Buddy (Behavioral)
结局指标
主要结局
treatment protocol adherence
时间窗: up to 8 weeks
How well does the subject adhere to treatment protocol. This will be defined by the number of treatment visits attended/ number of treatment visits scheduled \[excluding any treatment visits that have been cancelled by the clinicians\].
次要结局
- Number of adverse events(assessed at 2 months)
- Subject Satisfaction(assessed at 2 months)
- adverse event false alarm rate(assessed at 2 months)
- time to detect and resolve adverse events(assessed at 2 months)
研究者
Michael Paasche-Orlow
Associate Professor
Boston Medical Center