Promoting Resilience in Early Survivorship among Adolescents and Young Adults with Cancer.

提高患有癌症的青少年和年轻人的早期生存能力。

• 批准号: 10420520
• 负责人: Abby R Rosenberg
• 金额: $ 93.03万
• 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: 2022-03-10 至 2023-01-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10420520
• 关键词: Accelerometer; Address; Adolescent; Adolescent and Young Adult; Alaska; Anxiety; Award; Cancer Burden; Cancer Survivor; Cancer Survivorship; Caring; Cellular Phone; Clinical; Complement; Data; Development; Distress; Equilibrium; Evidence based program; Feeling; Goals; Gold; Guidelines; Hawaii; Health Technology; Human Resources; Intervention; Maintenance; Malignant Neoplasms; Mental Depression; Methods; Midwestern United States; Outcome; Patient Outcomes Assessments; Patients; Persons; Phase; Phenotype; Population; Psychosocial Assessment and Care; Quality of life; Randomized; Reporting; Reproducibility; Resources; Role; Self-Examination; Sequential Multiple Assignment Randomized Trial; Signal Transduction; Stress; Telephone; Text; Text Messaging; Time; Time Perception; Training; active method; anxiety symptoms; arm; base; cancer therapy; cost; design; digital; digital media; efficacy evaluation; evidence base; high risk; improved; improved outcome; innovation; instrument; intervention delivery; mHealth; medical specialties; mobile application; novel; phenotypic data; pilot test; programs; psychological distress; psychosocial; randomized trial; resilience; response; screening; secondary analysis; skills; smartphone Application; social; stress management; survivorship; telehealth; therapy design; tool; treatment as usual; trial design; video coaching; young adult

PROJECT SUMMARY Adolescents and early Young Adults (AYAs, 12-25 years-old) with cancer are at high risk of poor psychosocial outcomes because their distinct developmental challenges add to the burden of cancer. This is particularly true when AYAs transition from active treatment to cancer-surveillance (“early survivorship”) because this time demands increasing autonomy, re-integration into social, educational/vocational networks, and re-evaluation of self-identity. We created “Promoting Resilience in Stress Management” (PRISM): a novel, brief, skills-based program promoting AYA-endorsed “resilience resources” (stress-management, goal-setting, positive-reframing, and meaning-making). PRISM involves 4, 30-60 minute telehealth sessions between AYAs and certified PRISM coaches, plus an award-winning smartphone app. In a phase 2 randomized trial of 92 AYAs receiving cancer-treatment, PRISM improved patient-reported resilience, quality of life, hope, benefit-finding, and psychological distress early after its delivery, compared to usual care. While these findings were promising, they were tempered by 3 key threats to PRISM’s scalability: (1) PRISM’s delivery demands scarce human resources that might be replaced by digital media; (2) PRISM’s durability was limited after the study ended; and, (3) we lacked tools to recognize real-time changes in AYA distress that warranted additional support. Thus, we now propose a multi-center, Sequential, Multiple Assignment, Randomized Trial (SMART) to address these 3 barriers among AYA survivors of cancer. Specifically, we aim to: (1) Evaluate the efficacy of video- and text-PRISM coaching vs. the self-guided mPRISM app; (2) Determine the optimal method for maintenance of PRISM-response; and (3) Explore correlations between patient-reported resilience, distress, hope, quality of life, anxiety, and depression with validated instruments and: (a) in-app resilience and stress ratings, and (b) digital phenotype (passive smart-phone data including phone/text logs and accelerometer data). With SMART design, N=325 English or Spanish speaking AYAs from 3 diverse U.S. regions (Northwest/Alaska/Hawaii, Midwest, and South) who completed cancer-directed therapy within the past 2 years will be randomized 1:2:2 first to receive app-only, video, or text-based PRISM lay-coaching. Responders in the video- and text- arms will be randomized 1:1 second to app-only (low) maintenance or text- based (high) maintenance. Because non-response suggests a demand for more in-person engagement, text non-responders will be non-randomly assigned to video, and video non-responders will receive referrals to specialty care. Exploratory analyses will evaluate the role of in-app and digital phenotypic data in detecting real-time AYA distress. This proposal is significant because early survivorship is highly stressful for AYAs with cancer, and we propose a scalable, evidence-based program to support AYA resilience. Findings will facilitate an accessible, sustainable, evidence-based program designed to target and meet the needs of thousands of AYAs, in turn alleviating the burdens of cancer survivorship and improving their quality of life.

项目摘要 青少年和早期的年轻人（AYA，12-25岁）患有癌症的高风险很高 结果是因为它们的独特发展挑战增加了癌症的伯宁。这尤其正确 当AYA从主动治疗转变为癌症疗法（“早期生存”）时，因为这次 要求增加自治，重新融入社会，教育/职业网络，并重新评估 自我认同。我们创建了“促进压力管理中的韧性”（Prism）：一种新颖的，简短的，基于技能的技巧 促进AYA认可的“弹性资源”的计划（压力管理，目标设定，正面反应， 和意义制造）。棱镜涉及AYA和经认证之间的4，30-60分钟的远程医疗课程 Prism教练，以及屡获殊荣的智能手机应用程序。在92 AYA接收的2阶段随机试验中 癌症治疗，棱镜改善了患者报告的韧性，生活质量，希望，福利，并 与通常的护理相比，心理困扰早期分娩后。虽然承诺这些发现，但 他们受到对棱镜可伸缩性的3个关键威胁的调整：（1）棱镜的交付要求人类稀缺 可能被数字媒体取代的资源； （2）研究结束后，棱镜的耐用性受到限制； （3）我们缺少工具来识别AYA遇险中的实时变化，这需要提供额外的支持。 这是，我们现在提出了一个多中心，顺序，多个分配，随机试验（SMART）来解决 AYA癌症存活中的这3个障碍。具体而言，我们的目标是：（1）评估视频的效率 - 和文本 - 普里斯•教练与自我指导的MPRISM应用程序； （2）确定最佳方法 维持棱镜反应； （3）探索患者报告的弹性之间的相关性， 遇险，希望，生活质量，动画和抑郁症具有经过验证的工具，并且：（a）应用程序 弹性和压力等级，以及（b）数字表型（被动智能手机数据，包括电话/文本 日志和加速度计数据）。具有智能设计，n = 325英语或西班牙语，来自3位潜水员 美国地区（西北/阿拉斯加/夏威夷，中西部和南部），在内部完成了癌症指导的治疗 过去2年将首先随机分配1：2：2，以接收仅应用程序，视频或基于文本的Prism laycouching。 视频和文本武器中的响应者将被随机分配1：1秒，仅适用于应用程序（低）维护或文本 - 基于（高）维护。因为无响应表明对更多面对面参与的需求，所以 非响应者将非随机分配给视频，视频非响应者将收到转介给 专业护理。探索性分析将评估应用内和数字表型数据检测的作用 实时aya遇险。该提议很重要，因为早期生存对AYA的压力很大 癌症，我们提出了一项可扩展的基于证据的计划，以支持AYA的弹性。调查结果将有助于 旨在针对和满足数千个需求的可访问，可持续，基于证据的计划 AYAS，反过来减轻了癌症生存的伯恩斯，并改善了其生活质量。