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

旨在改善青少年和青年 (AYA) 癌症幸存者的医疗资源 [INSPIRE] 的交互式幸存者计划

• 批准号: 10603036
• 负责人: KEVIN S BAKER
• 金额: $ 53.09万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603036
• 关键词: INteractive; Survivorship; Program; Improve; Healthcare

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.

项目概要/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来减轻和管理不利的长期结果，U01 AYA 癌症幸存者。通过改善生存资源、健康素养和自我管理技能的获取 和支持，该干预措施旨在提高对 AYA 医疗保健指南的遵守率并减少癌症- 相关的困扰。该项目利用现有的生存信息学基础设施、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) 经验 AYA 和数字和远程医疗项目最初是为造血细胞移植幸存者开发的。这 该研究通过提供一种新颖的、个性化的、基于技术的自我护理方法，填补了 AYA 幸存者护理方面的一个关键空白。 分级护理远程医疗管理计划。为了可扩展，它使用基于风险的交付模型 向有明显需要的 AYA 幸存者提供。两臂 RCT 将测试 AYA 改编的 INSPIRE 数字程序， 包括交互式移动应用程序/网站和社交媒体，为患有以下疾病的人添加阶梯护理远程医疗 持续痛苦、缺乏生存医疗保健素养或在 1 个月内未使用数字程序的人。 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 其次是延迟访问 INSPIRE 程序。具体目标是： 1) AYA 幸存者中患有高 癌症相关的痛苦，确定自我管理计划 INSPIRE 的有效性，该计划由互动式提供 与主动控制臂相比，数字跨设备选项和分级护理远程医疗指导。 2) 其中 未能充分遵守医疗保健指南的 AYA 幸存者，确定 INSPIRE 数字的功效 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 与主动对照组相比，随后的恶性肿瘤监测。 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、癌症对 AYA 的特定影响以及医疗保健障碍；和 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 INSPIRE 计划如果以扩大的护理模式提供。探索性目标将评估传播情况 潜力并定义与痛苦、较差的健康状况或不遵守医疗保健相关的风险模型。目标 将通过对 N=980 名 AYA 白血病幸存者进行的双臂、多中心、风险分层随机对照试验来完成， 淋巴瘤、结直肠癌、黑色素瘤或肉瘤，年龄 18-39 岁，以及诊断后 1-5 年。初级 结果是 3 个月时痛苦减轻；次要结果是提高依从性并减少痛苦 12个月大时。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学的管理和主要数字干预计划，为 AYA 幸存者提供帮助。