Yi Jean C, Ballard Sheri, Walsh Casey, Friedman Danielle N, Ganz Patricia A, Jacobs Linda A, Partridge Ann H, Mitchell Sandra A, Leisenring Wendy M, Syrjala Karen L, Baker K Scott
Fred Hutchinson Cancer Center, USA.
Fred Hutchinson Cancer Center, USA.
Contemp Clin Trials. 2025 Jan;148:107745. doi: 10.1016/j.cct.2024.107745. Epub 2024 Nov 17.
Adolescents and young adults with cancer (AYAs, ages 15-39 at the time of diagnosis) experience significant adverse health and psychosocial outcomes. AYAs live with emotional distress and health care demands that exceed those of their healthy peers but can have difficulty accessing care. Digitally delivered interventions are an attractive option for AYA survivors, a population that routinely utilizes online resources when seeking health information and support.
By improving access to survivorship resources and support and strengthening health literacy and self-management skills, the INteractive Survivorship Program to Improve Health care REsources [INSPIRE] is designed to improve adherence to AYA health care guidelines and reduce cancer-related distress. We describe the protocol for a two-arm randomized controlled trial (RCT) testing the AYA-adapted INSPIRE program.
METHODS/DESIGN: The intervention includes an interactive mobile app, study website, and social media platforms, adding telehealth for those with continued distress, lower survivorship health care literacy, or poor engagement with the digital program at 6 weeks. Participants are randomized to INSPIRE or an active control. In the active control arm, survivors receive access to a study website with links to existing AYA survivor resources followed by delayed access to the INSPIRE program. Participants are not blinded; study staff not providing telehealth are blinded. The primary outcomes are cancer-related distress and health care adherence specific to second cancer and cardiometabolic screenings.
If effective, the program is positioned for accelerated implementation to improve care for AYA survivors by using a scalable informatics-based administration and largely digital intervention program.
患有癌症的青少年和青年（AYA，诊断时年龄在15 - 39岁）经历着显著的不良健康和心理社会后果。AYA面临着情绪困扰和医疗保健需求，这些需求超过了他们健康同龄人，但在获得护理方面可能存在困难。数字交付的干预措施对于AYA幸存者来说是一个有吸引力的选择，这一群体在寻求健康信息和支持时经常使用在线资源。
通过改善获得生存资源和支持的机会，以及加强健康素养和自我管理技能，旨在改善对AYA医疗保健指南的依从性并减少癌症相关困扰的交互式改善医疗保健资源生存计划（INSPIRE）。我们描述了一项双臂随机对照试验（RCT）的方案，该试验测试了适用于AYA的INSPIRE计划。
方法/设计：干预措施包括一个交互式移动应用程序、研究网站和社交媒体平台，对于在6周时仍有持续困扰、生存医疗保健素养较低或对数字计划参与度差的人增加远程医疗服务。参与者被随机分配到INSPIRE组或积极对照组。在积极对照组中，幸存者可以访问一个研究网站，该网站链接到现有的AYA幸存者资源，随后延迟访问INSPIRE计划。参与者不设盲；不提供远程医疗服务的研究人员设盲。主要结局是与癌症相关的困扰以及针对二次癌症和心脏代谢筛查的医疗保健依从性。
如果有效，该计划有望通过使用可扩展的基于信息学的管理和主要为数字的干预计划来加速实施，以改善对AYA幸存者的护理。
