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.

项目概要 患有癌症的青少年和早期年轻人（AYA，12-25 岁）面临社会心理不良的高风险 因为他们独特的发育挑战增加了癌症的负担。这一点尤其正确 当 AYA 从积极治疗过渡到癌症监测（“早期生存”）时，因为这一次 要求增加自主权，重新融入社会、教育/职业网络，以及重新评估 自我认同。我们创建了“促进压力管理的复原力”（PRISM）：一个新颖、简短、基于技能的工具 促进 AYA 认可的“弹性资源”的计划（压力管理、目标设定、积极重构、 和意义创造）。 PRISM 涉及 AYA 和经过认证的人员之间进行 4 次 30-60 分钟的远程医疗会议 PRISM 教练，以及屡获殊荣的智能手机应用程序。在一项对 92 名接受治疗的 AYA 进行的 2 期随机试验中 PRISM 改善了患者报告的癌症治疗、生活质量、希望、获益发现和 与常规护理相比，产后早期的心理困扰。虽然这些发现很有希望， 他们受到 PRISM 可扩展性的 3 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的耐用性受到限制； (3) 我们缺乏识别 AYA 痛苦实时变化的工具，而这需要额外的支持。 因此，我们现在提出一项多中心、序贯、多重分配、随机试验（SMART）来解决 AYA 癌症幸存者面临这 3 个障碍。具体来说，我们的目标是：（1）评估视频的有效性 文本 PRISM 辅导与自我引导 mPRISM 应用程序； (2) 确定最优方法 维护 PRISM 响应； (3) 探索患者报告的复原力之间的相关性， 使用经过验证的仪器来测量苦恼、希望、生活质量、焦虑和抑郁以及：(a) 应用内 弹性和压力评级，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）。采用 SMART 设计，N=325 名来自 3 个不同国家的讲英语或西班牙语的 AYA 美国地区（西北/阿拉斯加/夏威夷、中西部和南部）在 过去 2 年将按照 1:2:2 的比例随机分配，首先接受仅应用程序、视频或基于文本的 PRISM 外行辅导。 视频和文本臂中的响应者将以 1:1 秒的比例随机分配到仅应用程序（低）维护或文本臂 基础（高）维护。因为没有回复表明需要更多的面对面参与，所以文本 无响应者将被非随机分配到视频，视频无响应者将收到推荐 特殊护理。探索性分析将评估应用程序内和数字表型数据在检测中的作用 实时AYA遇险。该提案意义重大，因为早期生存对于患有以下疾病的 AYA 来说压力很大： 癌症，我们提出了一个可扩展的、基于证据的计划来支持 AYA 的恢复力。调查结果将有助于 一个易于使用、可持续、基于证据的计划，旨在瞄准和满足数千人的需求 AYA 反过来又减轻了癌症幸存者的负担并提高了他们的生活质量。