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: 10703839
• 负责人: Alexandra Psihogios
• 金额: $ 12.31万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-10-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10703839
• 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; mHealth methodology; modifiable behavior; multidisciplinary; negative mood; novel; personalized intervention; physical symptom; pilot test; 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.

项目摘要/摘要 青少年和年轻人（AYA）的停滞生存率和癌症的复发率部分归因于 可修改的健康行为 - 临界癌症治疗的依从性。但是，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，这是该K08的长期目标 应用是为了帮助解决AYA中癌症治疗结果的差异，通过靶向不遵守 挽救生命的癌症治疗。该提案的目的是采用新颖的实时移动健康 检查和干预时间变化的，上下文因素的方法，影响AYA的依从性 进行称为6-羟托嘌呤的口服化学疗法，必须每天在维护阶段服用 防止继电器。在AIM 1中，PI和她的Mentalship团队将确定 随时间变化的上下文因素（例如疲劳，动机）和每日6-尾托依性。这个目标 将利用6个月的密集纵向设计，员工爆发了基于移动的生态瞬间 对AYA患者及其护理人员进行评估（n = 30对）。在AIM 2中，调查团队将开始 开发一种恰当的自适应移动干预措施，旨在在此促进6-尾托嘌呤的依从性 人口，通过制定上下文规范的移动消息和有关条件下的条件的决策规则 传递消息。及时的移动干预措施非常适合解决 以前的干预措施只有在需要的时候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发展方法 迭代编码自我管理理论，经验证据，专家投入和利益相关者的反馈。 AIM 1的焦点小组将进行用户测试并完善消息。在AIM 3中 即时自适应移动干预称为AYA Adapts（依从性评估和个性化 及时支持）将在一项微型试验中对30名新招募的患者进行试验测试。 Aya适应 将整合在AIM 2中制定和完善的量身定制的移动消息和决策规则。 团队将确定此干预措施为PI大规模做准备的可行性和可接受性 优化试验（R01提案）。该建议具有方法论，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的支持 丰富的学术环境将支持PI向拥有的独立临床科学家的过渡 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 - 小儿癌患者的促进干预措施。该K08将为获得技能和 知识在：（1）生态瞬时评估和多层统计，（2）行为改变干预措施 开发适用于移动健康，以及（3）进行临床试验和干预传播的行为 执行。