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: 10879334
• 负责人: Abby R Rosenberg
• 金额: $ 91.64万
• 依托单位: DANA-FARBER CANCER INST
• 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 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10879334
• 关键词: Accelerometer; Address; Adolescent; Adolescent and Young Adult; Adolescent and young adult cancer patients; Alaska; Anxiety; Award; Cancer Burden; Cancer Survivor; Cancer Survivorship; Caring; Cellular Phone; Certification; Clinical; Complement; Creativeness; Data; Data Correlations; Deterioration; Development; Distress; Education; 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; Vocation; active method; anxiety symptoms; arm; 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; promote resilience; 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 患有癌症的青少年和早期年轻人（AYAs，12-25岁）处于心理社会不良的高风险中。 这是因为他们独特的发育挑战增加了癌症的负担。尤其如此 当AYAs从积极治疗过渡到癌症监测（“早期生存”）时， 要求增加自主权，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“促进压力管理中的弹性”（PRISM）：一个新颖，简短，基于技能的 促进AYA认可的“复原力资源”（压力管理，目标设定，积极重构， 意义（meaning-making）PRISM涉及AYAs和认证的AYAs之间的4个30-60分钟的远程医疗会话 PRISM教练，加上一个屡获殊荣的智能手机应用程序。 癌症治疗，PRISM改善了患者报告的恢复力，生活质量，希望，获益发现， 心理困扰早在其交付后，相比，通常的照顾。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的交付需要很少的人力， （2）PRISM的持久性在研究结束后是有限的; 以及，（3）我们缺乏工具来识别AYA困境中需要额外支持的实时变化。 因此，我们现在提出一项多中心、序贯、多重分配、随机试验（SMART），以解决 AYA癌症幸存者的这3个障碍。具体而言，我们的目标是：（1）评估视频的功效- 和文本PRISM教练与自我指导mPRISM应用程序;（2）确定最佳方法， PRISM反应的维持;和（3）探索患者报告的弹性之间的相关性， 痛苦，希望，生活质量，焦虑和抑郁与验证的工具和：（a）应用程序内 弹性和压力等级，以及（B）数字表型（包括电话/文本的被动智能电话数据 日志和加速计数据）。采用SMART设计，N=325名讲英语或西班牙语的AYA，来自3个不同的 美国地区（西北部/阿拉斯加/夏威夷、中西部和南部）， 过去2年将以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实习指导。 视频组和文本组的应答者将以1：1的比例随机分配至仅应用程序（低）维持或文本组。 高度（High）维护。因为不回应意味着需要更多的面对面接触，所以短信 无应答者将被非随机分配到视频，视频无应答者将被转介到 专科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 实时AYA遇险。这一建议意义重大，因为早期生存对AYA来说压力很大， 癌症，我们提出了一个可扩展的，以证据为基础的计划，以支持AYA的弹性。调查结果将有助于 一个可访问的，可持续的，以证据为基础的计划，旨在针对和满足成千上万的需求， AYA，反过来减轻癌症生存的负担，提高他们的生活质量。