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.

项目概要/摘要 除了应对疾病之外，患有癌症的青少年和年轻人 (AYA) 还需与其他疾病作斗争 与年龄相关的独立、教育、就业、人际关系和发展方面的挑战 患有癌症的 AYA 面临短期和长期不良结果（包括精神不良）的高风险。 健康、社会孤立、危险健康行为、失业和生活质量下降。 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医疗进行部署 （移动医疗）平台显示出良好的治疗效果，有助于克服传统障碍。 面对面的交付模式，并且对 AYA 非常有吸引力。然而，移动医疗干预措施的重点是。 改善生活质量和心理社会结果尚未成功评估或实施 该应用程序建立在我之前的“促进压力恢复力”工作的基础上。 “（PRISM）对患有癌症的 AYA 进行干预。这种新颖、简短、循证的 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。 我的团队已将这种面对面的干预措施改编为自我引导的移动医疗干预措施 mPRISM。 混合方法提案有以下 3 个互补目标：（目标 1）评估可行性， 在一项试点随机试验中，mPRISM 对患有癌症的 AYA 的可接受性和探索性疗效（目标 2） 分析后端数字使用模式，以便识别和定位相关数字参与的各个方面 改善社会心理结果；以及（目标 3）评估采用收养的障碍和促进因素 通过与患者和诊所利益相关者进行半结构化退出访谈，在临床环境中进行移动医疗干预。 该提案具有技术、方法和传播创新，具有扩大规模的潜力 K08 将提供克服心理社会治疗的结构性障碍的干预措施。 获得以下方面技能和知识的机会： 作为 PI 的高级临床试验研究； 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，得到多方支持。 学科专家团队（AYA 肿瘤学、实施科学、移动医疗和移动分析、临床 试验研究、高级统计和定性方法）并在丰富的学术环境中，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 边缘移动健康方法促进对 AYA 肿瘤患者实施循证护理。 该提案将为 PI 的大规模多地点混合有效性实施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，并实施科学举措，以缩小研究与实践之间的差距。