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

针对患有癌症的青少年和年轻人的移动健康心理社会干预试点试验

• 批准号: 10448700
• 负责人: Nancy Lau
• 金额: $ 20.42万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10448700
• 关键词: Address; Adherence; Adolescent and Young Adult; Adopted; Adoption; Age; Anxiety; Behavior Therapy; Behavioral; Cancer Burden; Cancer Patient; Caring; Cellular Phone; Childhood; Chronic Disease; Clinic; Clinical; Clinical Trials; Cognitive; Collaborations; Dependence; Development; Development Plans; Distress; Dose; Education; Elderly; Employment; Enrollment; Environment; Funding; Future; Gender; Goals; Health Personnel; Health Services Accessibility; Health Technology; Health behavior; Improve Access; Intervention; Interview; Knowledge; Linear Regressions; Long Term Survivorship; Malignant Neoplasms; Measures; Medical; Mental Depression; Mental Health; Mentors; Mentorship; Methodology; Methods; Modeling; Oncology; Outcome; Participant; Patients; Pattern; Persons; Population; Psychosocial Assessment and Care; Qualitative Methods; Qualitative Research; Quality of life; Race; Randomized; Recording of previous events; Research; Research Methodology; Research Personnel; Risk; Scientist; Secure; Service delivery model; Site; Social isolation; Stress and Coping; Structure; Technology; Testing; Time; Training; Unemployment; Waiting Lists; Well in self; Work; Youth; acceptability and feasibility; age related; base; career; career development; cohort; coping; cost; cost effectiveness; design; digital; disability; effectiveness implementation study; effectiveness implementation trial; evidence base; experience; follow-up; health related quality of life; high risk; implementation measures; implementation outcomes; implementation science; implementation strategy; improved; improved outcome; innovation; interest; mHealth; meetings; mindfulness; mindfulness intervention; multidisciplinary; novel; pilot trial; portability; post-traumatic stress; prevent; programs; psychosocial; randomized trial; research and development; resilience; response; retention rate; scale up; self help; skills; statistics; stress management; theories; treatment as usual; treatment effect; usual care arm; young adult

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.

项目摘要/摘要 除了应对医疗疾病外，青少年和年轻人（AYAS）与癌症斗争 独立，教育，就业，人际关系和年龄相关的发展挑战 身份。患有癌症的AYA的短期和长期结局的高风险，包括精神差 健康，社会隔离，危险的健康行为，失业和生活质量差。随着快速上升 数字技术，基于技能的社会心理干预措施越来越多地通过移动健康部署 （MHealth）平台。这种干预措施显示出令人鼓舞的治疗效果，有助于克服传统的障碍 面对面交付模型，对AYAS高度吸引力。但是，MHealth的干预措施的重点是 尚未成功评估或实施改善生活质量和社会心理成果 在AYA癌症患者中。该应用程序以我先前的工作为基础 管理”（PRISM）干预AYA与癌症的干预。这本小说，简短的，循证的1：1干预 教授压力管理，目标设定，含义制作，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调整为自我引入的MHealth干预MPRism。 混合方法提案具有以下3个完整目标：（目标1）评估可行性， 在试验随机试验中，MPRISM对AYA的可接受性和探索性效率； （目标2） 分析后端数字用法模式，以识别和针对数字参与的方面相关的方面 随着社会心理结局的改善； （目标3）评估采用障碍和促进者 通过与患者和诊所利益相关者进行半结构化退出访谈，在临床环境中进行了MHealth干预措施。 该建议具有技术，方法论和传播创新，以扩大规模 克服心理社会治疗的结构障碍的干预措施。这个K08将提供 获取技能和知识的机会：高级临床试验研究作为PI； MHealth研究 包括干预测试，数字分析以及优化参与和采用的策略；和 高级实施科学方法。研究和职业发展计划，由多个 纪律专家团队（在AYA肿瘤学，实施科学，MHealth和Mobile Analytics，临床上 试验研究，高级统计和定性方法）以及在丰富的学术环境中，将支持 PI向独立临床科学家的过渡，他们拥有使用裁缝的技能和专业知识 边缘移动健康方法促进针对AYA肿瘤学患者实施基于证据的护理。 该提案将为PI的大规模多站点混合有效性试验的设计提供信息 MPRISM（R01提案）。与NCI的优先事项保持一致，该研究计划将促进证据 - 基于改善生活质量的基于行为干预措施，利用便携式低成本技术 扩展获得护理和实施科学计划，以弥合研究实践差距。