Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults with Leukemia

项目摘要/摘要 患有癌症的青少年和年轻人(AYA)的生存停滞和复发率是部分原因 一种可改变的健康行为--次优癌症治疗依从性。然而，有效的干预措施是 缺乏。与NCI和其他联邦机构的优先事项保持一致，K08的长期目标 应用程序是通过针对不遵守以下原则来帮助解决阿雅癌症治疗结果的差异 挽救生命的癌症治疗。该提案的目标是采用新的实时移动医疗 检查和干预影响Aya遵守的时变、背景因素的方法论 一种名为6-巯基嘌呤的口服化疗，必须在维持阶段每天服用，以 防止复发。在目标1中，PI和她的指导团队将确定时间上的关联 时变的环境因素(如疲劳、动力)和每日6-巯基嘌呤的依从性。这一目标 将采用为期6个月的密集纵向设计，采用基于移动的瞬间生态突发 与AYA患者及其照顾者(n=30对)进行评估。在目标2中，调查小组将开始 开发一种即时自适应移动干预，旨在促进6-巯基嘌呤在 通过开发针对上下文量身定做的移动消息和关于以下条件的决策规则 用来传递信息的。即时移动干预非常适合解决以下限制 以前的干预措施，只在需要的时候，在正确的时间提供个性化的遵守支持。 消息和决策规则的创建将遵循严格的移动卫生发展方法，方法是 反复结合自我管理理论、经验证据、专家意见和利益相关者反馈。 来自Aim 1的15个Aya的焦点小组将进行用户测试和提炼信息。在目标3中， 称为Aya Adapts(遵守评估和个性化)的即时自适应移动干预 将在一个微型随机试验中对30名新招募的患者进行试点测试。阿雅适应 将整合在目标2中开发和改进的定制移动消息和决策规则。 团队将确定这种干预的可行性和可接受性，为PI的更大规模做准备 优化试验(R01方案)。这一建议有方法论、理论、临床和技术 创新。研究和职业发展计划，由一个多学科的专家团队在一个 丰富的学术环境，将支持PI向独立的临床医生-科学家过渡，拥有 使用尖端移动健康方法设计最有效的依从性的技能和专业知识- 针对儿童癌症患者的宣传干预。这个K08将提供获得技能和 了解：(1)生态瞬时评估和多层次统计；(2)行为改变干预 适用于移动卫生的开发，以及(3)进行临床试验和干预传播以及 实施。

PROJECT SUMMARY/ABSTRACT Stagnant survival and relapse rates for adolescents and young adults (AYA) with cancer are partially attributed to a modifiable health behavior—suboptimal cancer treatment adherence. Yet, effective interventions are lacking. Aligned with priorities of the NCI and other federal agencies, the long-term objective of this K08 application is to help resolve disparities in cancer treatment outcomes in AYA by targeting nonadherence to life-saving cancer treatments. The goal of this proposal is to employ novel real time mobile health methodologies to examine and intervene on the time-varying, contextual factors that influence AYA adherence to an oral chemotherapy called 6-mercaptopurine, which must be taken daily in the maintenance phase to prevent relapse. In Aim 1, the PI and her mentorship team will determine the temporal associations between time-varying contextual factors (such as fatigue, motivation) and daily 6-mercaptopurine adherence. This Aim will utilize a 6-month intensive longitudinal design that employs bursts of mobile-based ecological momentary assessment with AYA patients and their caregivers (n=30 pairs). In Aim 2, the investigative team will begin to develop a just-in-time adaptive mobile intervention, designed to promote 6-mercaptopurine adherence in this population, by developing contextually-tailored mobile messages and decision rules about the conditions under which to deliver the messages. Just-in-time mobile interventions are well-suited to address limitations of previous interventions by providing personalized adherence support, at the right time, only when it is needed. The creation of messages and decision rules will follow a rigorous mobile health development approach by iteratively incorporating self-management theory, empirical evidence, expert input, and stakeholder feedback. Focus groups with 15 AYA from Aim 1 will be conducted to user-test and refine the messages. In Aim 3, the just-in-time adaptive mobile intervention called AYA ADAPTS (Adherence Assessments and Personalized Timely Support) will be pilot tested in a micro-randomized trial with 30 newly recruited patients. AYA ADAPTS will integrate the tailored mobile messages and decision rules developed and refined in Aim 2. The research team will determine the feasibility and acceptability of this intervention in preparation for the PI's larger-scale optimization trial (R01 proposal). This proposal has methodological, theoretical, clinical, and technological innovations. The research and career development plan, supported by a multi-disciplinary team of experts in a rich academic environment, will support the PI's transition to an independent clinician-scientist who possesses the skills and expertise to use cutting-edge mobile health methods to design the most potent adherence- promotion interventions for pediatric cancer patients. This K08 will provide opportunities to acquire skills and knowledge in: (1) ecological momentary assessment and multi-level statistics, (2) behavior change intervention development applied to mobile health, and (3) the conduct of clinical trials and intervention dissemination and implementation.