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.

项目总结 患有癌症的青少年和早期青壮年(12-25岁)是心理社会不良的高危人群 结果，因为他们独特的发展挑战增加了癌症的负担。这一点尤其正确 当AYAS从积极治疗过渡到癌症监测(“早期生存”)时，因为这次 要求提高自主权，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《在压力管理中促进韧性》(PRISM)：一个新颖、简短、以技能为基础的 促进阿亚认可的“复原力资源”的计划(压力管理、目标设定、积极重组、 和意义创造)。PRISM包括在AYA和认证机构之间进行4、30-60分钟的远程医疗会议 棱镜教练，外加一个获奖的智能手机应用程序。在一项2期随机试验中，92名AYA患者接受了 癌症治疗，PRISM改善了患者报告的弹性、生活质量、希望、受益发现和 与通常的护理相比，分娩后早期的心理痛苦。虽然这些发现是有希望的， PRISM的可扩展性受到三个关键威胁的影响：(1)PRISM的交付需要稀缺的人力 可能被数字媒体取代的资源；(2)研究结束后，PRISM的持久性有限； 而且，(3)我们缺乏工具来识别需要额外支持的Aya痛苦的实时变化。 因此，我们现在提出一种多中心、序贯、多任务、随机试验(SMART)来解决 在癌症幸存者中，这三个障碍。具体地说，我们的目标是：(1)评估视频- 和文本-棱镜指导与自我指导的mPRISM APP；(2)确定 维持PRISM反应；以及(3)探索患者报告的复原力与 痛苦、希望、生活质量、焦虑和抑郁，使用经过验证的工具和：(A)在应用程序中 恢复力和压力评级，以及(B)数字表型(被动智能手机数据，包括电话/短信 日志和加速度计数据)。凭借智能设计，N=325个来自3个不同国家的英语或西班牙语AYA 完成癌症导向治疗的美国地区(西北/阿拉斯加/夏威夷、中西部和南部) 过去两年将以1：2：2的随机比例首先接受基于应用程序、视频或文本的PRISM Lay-Coach培训。 视频和文本臂中的响应者将被随机分配为仅限应用(低)维护或文本-1秒 基础(高)维护。因为没有回复意味着需要更多的面对面交流，所以短信 非响应者将被非随机分配到视频，而视频非响应者将收到转介到 专科护理。探索性分析将评估应用内和数字表型数据在检测中的作用 实时的阿雅求救。这一建议意义重大，因为早期生存对AYA来说压力很大 我们提出了一个可扩展的、基于证据的计划来支持Aya的复原力。调查结果将有助于 一个可访问的、可持续的、基于证据的计划，旨在针对和满足数千人的需求 Ayas，进而减轻癌症生存的负担，提高他们的生活质量。