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

使用实时移动健康方法来了解和促进患有白血病的青少年和年轻人的口服化疗依从性

• 批准号: 10221647
• 负责人: Alexandra Psihogios
• 金额: $ 12.98万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10221647
• 关键词: 6-Mercaptopurine; Acute Lymphocytic Leukemia; Address; Adherence; Adolescent and Young Adult; Affect; Age; Behavior Therapy; Cancer Control; Cancer Patient; Caregivers; Chronic; Clinical; Clinical Trials; Conduct Clinical Trials; Cross-Sectional Studies; Data; Data Collection; Development; Development Plans; Disease; Dissemination and Implementation; Ecological momentary assessment; Environment; Family; Fatigue; Feedback; Focus Groups; Goals; Health; Health behavior; Home; Individual; Intervention; Intervention Trial; Knowledge; Life; Maintenance; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical; Mentorship; Methodology; Methods; Monitor; Moods; Motivation; Oral; Outcome; Patient Recruitments; Patients; Pharmaceutical Preparations; Phase; Population; Preparation; Process; Publishing; Randomized; Relapse; Research; Research Personnel; Research Priority; Risk; Role; Sampling; Savings; Science; Scientist; Self Management; Specific qualifier value; Survival Rate; Targeted Research; Techniques; Testing; Time; Training; Treatment outcome; Work; acceptability and feasibility; adaptive intervention; adherence rate; age group; base; behavior change; cancer health disparity; cancer therapy; career; career development; chemotherapy; cohort; contextual factors; design; disorder later incidence prevention; effective intervention; handheld mobile device; health assessment; improved; individual variation; leukemia; longitudinal design; mHealth; modifiable behavior; multidisciplinary; negative mood; novel; personalized intervention; physical symptom; prevent; randomized trial; research and development; skills; statistics; success; technological innovation; theories; therapy design; therapy development; treatment adherence

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.

项目概要/摘要 患有癌症的青少年和年轻人 (AYA) 的生存率和复发率停滞不前是部分原因 然而，有效的干预措施是可改变的健康行为——次优的癌症治疗依从性。 与 NCI 和其他联邦机构的优先事项保持一致，是 K08 的长期目标。 该应用程序旨在通过针对不依从性的问题来帮助解决 AYA 中癌症治疗结果的差异 该提案的目标是采用新颖的实时移动医疗。 检查和干预影响 AYA 依从性的时变背景因素的方法 一种名为 6-巯基嘌呤的口服化疗药物，必须在维持阶段每天服用 在目标 1 中，PI 和她的指导团队将确定之间的时间关联。 随时间变化的环境因素（例如疲劳、动机）和每日 6-巯基嘌呤的依从性。 将采用为期6个月的密集纵向设计，采用基于移动的生态瞬间爆发 与 AYA 患者及其护理人员（n=30 对）进行评估 在目标 2 中，调查小组将开始进行评估。 开发一种及时的自适应移动干预措施，旨在促进 6-巯基嘌呤在此方面的依从性 人口，通过根据具体情况定制的移动消息和有关条件的决策规则来发展 及时的移动干预非常适合解决以下问题： 以前的干预措施，仅在需要时才在正确的时间提供个性化的依从性支持。 消息和决策规则的创建将遵循严格的移动健康开发方法 迭代地结合自我管理理论、经验证据、专家意见和利益相关者反馈。 来自目标 1 的 15 个 AYA 的焦点小组将进行用户测试并完善目标 3 中的信息。 称为 AYA ADAPTS（依从性评估和个性化 及时支持）将在一项微型随机试验中对 30 名新招募的 AYA ADAPTS 患者进行试点测试。 将整合目标 2 中开发和完善的定制移动消息和决策规则。该研究 团队将确定此干预措施的可行性和可接受性，为 PI 更大规模的干预做准备 优化试验（R01提案）该提案具有方法论、理论、临床和技术。 创新的研究和职业发展计划，由多学科专家团队支持。 丰富的学术环境，将支持 PI 转变为拥有以下能力的独立临床医生科学家 使用尖端移动健康方法来设计最有效的依从性的技能和专业知识- K08 将为儿童癌症患者提供获得技能和干预措施的机会。 知识：（1）生态瞬时评估和多层次统计，（2）行为改变干预 应用于移动医疗的开发，以及（3）进行临床试验和干预措施传播和 执行。