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

项目摘要/摘要 除了与疾病作斗争外，患有癌症的青少年和青壮年(AYA)还在与 与年龄相关的发展挑战，如独立、教育、就业、关系和 身份。患有癌症的阿亚人有很高的短期和长期预后不良的风险，包括精神疾病。 健康、社会孤立、危险的健康行为、失业和糟糕的生活质量。随着中国经济的快速增长 数字技术、基于技能的心理社会干预措施越来越多地通过移动医疗进行部署 (MHealth)平台。这些干预措施显示出有希望的治疗效果，有助于克服传统的 面对面交付模式，对AYA非常有吸引力。然而，移动健康干预的重点是 改善生活质量和心理社会结果尚未得到成功评估或实施 在阿亚癌症患者中。这个应用程序建立在我之前的工作的基础上，我的工作是“促进压力下的弹性” 管理“(PRISM)干预对患有癌症的AYA。这一新颖、简短、基于证据的1：1干预 教授压力管理、目标设定、意义形成、认知行为和正念策略。我 我的团队已经将这种面对面的干预改造成了一种自我指导的mHealth干预，即mPRISM。这 混合方法提案有以下三个相辅相成的目标：(目标1)评估可行性， 先导性随机试验中mPRISM治疗癌症AYA的可接受性和探索性疗效；(目标2)至 分析后端数字使用模式，以便识别和确定相关数字参与的各个方面 改善心理社会结果；以及(目标3)评估阻碍采用 通过与患者和临床利益相关者的半结构化离职访谈，在临床环境中进行移动健康干预。 这项提议在技术、方法和传播方面都有创新，有可能扩大 克服获得心理社会治疗的结构性障碍的干预措施。这款K08将提供 有机会获得以下领域的技能和知识：高级临床试验研究；移动健康研究 包括干预测试、数字分析和优化参与和采用的战略；以及 先进的实施科学方法。研究和职业发展计划，由多个 学科专家团队(Aya肿瘤学、实施科学、移动健康和移动分析、临床 试验研究、高级统计和定性方法)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- 边缘移动健康方式，推动对阿雅肿瘤患者实施循证护理。 这项建议将为PI的大规模多站点混合有效性设计提供参考-实施试验 MPRISM(R01提案)。与NCI的优先事项保持一致，这项研究计划将促进证据- 基于提高生活质量的行为干预，利用便携式低成本技术 扩大获得护理的机会，并实施科学倡议，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.