An INteractive Survivorship Program to Improve Healthcare REsources [INSPIRE] for Adolescent and Young Adult (AYA) Cancer Survivors

项目总结/摘要 拟议的青少年和年轻人（AYA）混合方法项目将满足目标和科学范围 通过完善和测试可扩展的干预措施，以减轻和管理不利的长期结果， 癌症幸存者的研究通过改善获得生存资源、健康知识、自我管理技能 和支持，干预旨在提高遵守AYA医疗保健指南和减少癌症- 相关的苦恼。该项目利用现有的生存信息学基础设施， 多中心生存率研究网络，以及我们在一项随机对照试验（RCT）中的经验， AYAs和最初为造血细胞移植幸存者开发的数字和远程医疗计划。这 研究填补了护理AYA幸存者的关键空白，提供了一种新颖的，个性化的，基于技术的自我， 管理计划与阶梯护理远程保健。为了具有可扩展性，它使用基于风险的交付模型， 有需要的AYA幸存者。双臂随机对照试验将测试适应AYA的INSPIRE数字程序， 包括一个互动的移动的应用程序/网站和社交媒体，为那些有 持续的痛苦，缺乏生存保健知识，或在1个月内没有使用数字程序。 在主动控制组中，幸存者可以访问一个研究网站，该网站具有现有的AYA幸存者资源链接 随后是INSPIRE计划的延迟访问。具体目标是：1）在AYA幸存者中， 癌症相关的痛苦，确定自我管理计划，INSPIRE，由互动交付的疗效 与主动控制组相比，数字跨设备选项和阶梯式护理远程医疗指导。2） AYA幸存者没有充分遵守医疗保健指南，确定INSPIRE数字的有效性 和远程医疗自我管理计划，以改善整体医疗保健的依从性和心脏代谢或 与活性对照组相比，随后的恶性肿瘤监测。 干预效果，包括参与在线计划，使用远程保健联系人， 提高健康自我效能、健康素养、癌症对AYA的具体影响以及医疗保健障碍; 检查干预参与或反应的调节因素，包括癌症临床因素，健康状况， 社会人口和环境因素。4)定义维护和交付 INSPIRE计划，如果在一个规模扩大的护理模式提供。一个探索性的目标将评估传播 潜在的和定义与痛苦，健康状况较差或医疗保健不依从性相关的风险模型。旨在 将在N=980名AYA白血病幸存者中进行一项双臂、多中心、风险分层RCT， 淋巴瘤、结直肠癌、黑素瘤或肉瘤，年龄18-39岁，诊断后1-5年。主 结局是3个月时的痛苦减少;次要结局是依从性改善和痛苦减少 12个月大的时候如果有效，该计划将加速传播/实施，以改善护理 通过使用可扩展的基于信息的管理和主要的数字干预计划，为AYA幸存者提供服务。

PROJECT SUMMARY/ABSTRACT The proposed adolescent and young adult (AYA) mixed methods project will meet the goals and scientific scope of the U01 by refining and testing a scalable intervention to mitigate and manage adverse long-term outcomes in AYA cancer survivors. By improving access to survivorship resources, health literacy, self-management skills and support, the intervention is designed to improve adherence to AYA healthcare guidelines and reduce cancer- related distress. The project leverages an existing survivorship informatics infrastructure, an established multicenter survivorship research network, and our experiences with a randomized controlled trial (RCT) with AYAs and a digital and telehealth program initially developed for hematopoietic cell transplant survivors. This research fills a critical gap in care for AYA survivors by providing a novel, personalized, technology-based self- management program with stepped care telehealth. To be scalable, it uses a risk-based delivery model targeted to AYA survivors with demonstrated need. The two-arm RCT will test the AYA-adapted INSPIRE digital program, including an interactive mobile app/website and social media, adding stepped care telehealth for those with continued distress, lack of survivorship healthcare literacy, or who are not using the digital program at 1 month. In the active control arm, survivors receive access to a study website with existing AYA survivor resource links followed by delayed access to the INSPIRE program. Specific aims are: 1) Among AYA survivors with elevated cancer-related distress, determine the efficacy of a self-management program, INSPIRE, delivered by interactive digital cross-device options and stepped care telehealth coaching, compared to the active control arm. 2) Among AYA survivors with inadequate adherence to healthcare guidelines, determine the efficacy of the INSPIRE digital and telehealth self-management program in improving overall healthcare adherence and cardiometabolic or subsequent malignancy surveillance compared to the active control arm. 3) Examine mechanisms associated with intervention efficacy including engagement with the online program, use of telehealth contacts, and improved health self-efficacy, health literacy, AYA-specific impact of cancer, and barriers to healthcare; and examine moderators of intervention engagement or response including cancer clinical factors, health status, and sociodemographic and environmental factors. 4) Define costs of maintaining and delivering components of the INSPIRE program if delivered in a scaled-up model of care. An exploratory aim will assess dissemination potential and define risk models associated with distress, poorer health status or healthcare nonadherence. Aims will be accomplished with a two-arm, multicenter, risk-stratified RCT of N=980 AYA survivors of leukemia, lymphoma, colorectal cancer, melanoma, or sarcoma, age 18-39, and 1-5 years post-diagnosis. The primary outcome is reduced distress at 3 months; secondary outcomes are improved adherence and reduced distress at 12 months. If effective, the program is positioned for accelerated dissemination/implementation to improve care for AYA survivors by using a scalable informatics-based administration and largely digital intervention program.