Pilot trial testing mobile health psychosocial intervention for Adolescentsand Young Adults with cancer

项目总结/摘要 除了应对他们的医疗疾病，青少年和年轻人（AYAs）与癌症斗争， 与年龄相关的独立性、教育、就业、人际关系等发展挑战， 身份患有癌症的AYA患者短期和长期结果不佳的风险很高，包括精神状况不佳。 健康、社会孤立、危险的健康行为、失业和生活质量差。随着人口的迅速增长， 数字技术、基于技能的心理社会干预越来越多地通过移动的健康部署 （mHealth）平台。这些干预措施显示出有希望的治疗效果，有助于克服传统治疗的障碍， 面对面的交付模式，对AYA非常有吸引力。然而，移动健康干预措施的重点是 改善生活质量和心理社会结果尚未得到成功评价或实施 AYA癌症患者中。这个应用程序建立在我以前的工作与“促进弹性的压力 管理”（PRISM）对患有癌症的AYA的干预。这种新颖、简短、基于证据的1：1干预 教授压力管理、目标设定、意义创造、认知行为和正念策略。我 和我的团队已经将这种面对面的干预调整为一种自我指导的移动健康干预，mPRISM。这 混合方法提案具有以下3个互补目标：（目标1）为了评估可行性， 在一项初步随机试验中，mPRISM治疗癌症AYA的可接受性和探索性疗效;（目的2） 分析后端数字使用模式，以识别和定位相关数字参与的各个方面， （目标3）评估采用社会心理学方法的障碍和促进因素， 通过与患者和诊所利益相关者的半结构化离职面谈，在临床环境中进行移动健康干预。 该提案在技术、方法和传播方面具有创新性，有可能扩大 采取干预措施，克服获得心理治疗的结构性障碍。K 08将提供 有机会获得以下方面的技能和知识：作为PI进行高级临床试验研究;移动健康研究 包括干预测试、数字分析以及优化参与和采用的策略; 先进的实施科学方法。研究和职业发展计划，由一个多- 学科专家团队（AYA肿瘤学、实施科学、移动健康和移动的分析、临床 试验研究，先进的统计学和定性方法）和丰富的学术环境，将支持 PI转变为独立的临床科学家，拥有使用切割的技能和专业知识， 边缘移动的健康方法，以促进对AYA肿瘤患者实施循证护理。 该提案将为PI的大规模多站点混合有效性实施试验的设计提供信息， mPRISM（R 01提案）。与NCI的优先事项相一致，这项研究计划将促进证据- 基于行为干预，提高生活质量，利用便携式低成本技术， 扩大获得护理的机会，并实施科学举措，以弥合研究与实践之间的差距。

PROJECT SUMMARY/ABSTRACT In addition to coping with their medical illness, Adolescents and Young Adults (AYAs) with cancer struggle with the age-related developmental challenges of independence, education, employment, relationships, and identity. AYAs with cancer are at high risk of poor short-term and long-term outcomes, including poor mental health, social isolation, risky health behaviors, unemployment, and poor quality of life. With the rapid rise in digital technologies, skills-based psychosocial interventions are increasingly deployed via mobile health (mHealth) platforms. Such interventions show promising treatment effects, help overcome barriers to traditional in-person delivery models, and are highly appealing to AYAs. However, mHealth interventions focused on improving quality of life and psychosocial outcomes have not yet been successfully evaluated or implemented among AYA cancer patients. This application builds on my prior work with the "Promoting Resilience in Stress Management" (PRISM) intervention for AYAs with cancer. This novel, brief, evidence-based 1:1 intervention teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. I and my team have adapted this in-person intervention to a self-guided mHealth intervention, mPRISM. This mixed-methods proposal has the following 3 complementary aims: (Aim 1) To evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM for AYAs with cancer in a pilot randomized trial; (Aim 2) To analyze backend digital usage patterns in order to identify and target aspects of digital engagement associated with improvement in psychosocial outcomes; and, (Aim 3) To assess barriers and facilitators to the adoption of mHealth interventions in clinical settings via semi-structured exit interviews with patient and clinic stakeholders. This proposal has technological, methodological, and dissemination innovations in potential for scale-up of interventions to overcome structural barriers to psychosocial treatment access. This K08 will provide opportunities to acquire skills and knowledge in: advanced clinical trials research as PI; mHealth research including intervention testing, digital analytics, and strategies to optimize engagement and adoption; and advanced implementation science methods. The research and career development plan, supported by a multi- disciplinary team of experts (in AYA oncology, implementation science, mHealth and mobile analytics, clinical trials research, advanced statistics, and qualitative methods) and in a rich academic environment, will support the PI’s transition to an independent clinical-scientist who possesses the skills and expertise to use cutting- edge mobile health methods to promote the implementation of evidence-based care for AYA oncology patients. This proposal will inform the design of the PI’s large-scale multi-site hybrid effectiveness-implementation trial of mPRISM (R01 proposal). Aligned with the NCI’s priorities, this program of research will promote evidence- based behavioral interventions that improve quality of life, the utilization of portable low-cost technologies to expand access to care, and implementation science initiatives to bridge the research-practice gap.