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

项目摘要/摘要 拟议的青少年和青年混合方法项目将达到目标和科学范围。 通过细化和测试可扩展的干预措施来缓解和管理不利的长期结果，从而降低U01的风险 在阿亚癌症幸存者身上。通过改善获得生存资源、健康素养、自我管理技能 和支持，干预旨在提高对Aya医疗保健指南的遵守，并减少癌症- 相关的苦恼。该项目利用了现有的生存信息基础设施，一个已建立的 多中心生存研究网络，以及我们的随机对照试验(RCT)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 研究通过提供一种新颖的、个性化的、基于技术的自我护理来填补Aya幸存者护理方面的关键空白 管理计划与阶梯式远程保健。为了具有可扩展性，它使用了基于风险的交付模式 给有明显需求的阿亚幸存者。双臂RCT将测试Aya适配的INSPIRE数字程序， 包括交互式移动应用程序/网站和社交媒体，为符合以下条件的人增加了阶梯式远程医疗 持续的痛苦，缺乏生存保健知识，或者在1个月时没有使用数字计划。 在主动控制臂中，幸存者可以访问具有现有Aya幸存者资源链接的研究网站 随后是对INSPIRE计划的延迟访问。具体目标是：1)在Aya幸存者中 与癌症相关的痛苦，决定自我管理计划的有效性，激励，通过互动传递 与主动控制臂相比，数字跨设备选项和步进式远程保健教练。2)在 Aya幸存者没有充分遵守医疗保健指南，决定了INSPIRE数字的疗效 和远程医疗自我管理计划，以提高整体医疗保健依从性和心脏代谢或 随后的恶性肿瘤监测与主动控制组进行比较。3)检查相关机制 干预效果，包括参与在线计划，使用远程医疗联系人，以及 提高健康自我效能、健康素养、癌症的特定影响和医疗保健障碍；以及 检查干预参与或反应的调节因素，包括癌症临床因素、健康状况和 社会人口和环境因素。4)定义维护和交付组件的成本 如果以扩展的护理模式提供激励计划。一个探索性目标将评估传播 潜在并定义与痛苦、较差的健康状况或不遵守医疗保健有关的风险模型。目标 将通过N=980名白血病幸存者的双臂、多中心、风险分层随机对照试验来实现， 淋巴瘤、结直肠癌、黑色素瘤或肉瘤，年龄18-39岁，确诊后1-5年。初级阶段 结果是在3个月时减少了痛苦；次要结果是提高了依从性和减少了痛苦 在12个月的时候。如果有效，该方案将加速传播/实施，以改善护理 通过使用可扩展的基于信息学的管理和主要是数字干预计划，为Aya幸存者提供支持。

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.