The ASPIRES Study: Activating Cancer Survivors and their Primary Care Providers to Increase Colorectal Cancer Screening

项目摘要 接受腹部或盆腔放射治疗(RT)的儿童癌症幸存者几乎是接受治疗的四倍 与普通人群相比，有可能患上结直肠癌(CRC)，他们的风险明显增加 30岁，没有平台期。由于早期发现癌前病变(即腺瘤)或结直肠癌 与提高存活率、结肠镜筛查或多靶点粪便DNA检测(mt- 建议从30岁开始，在阳性检测后进行结肠镜检查。不幸的是，广大的 大多数处于结直肠癌高危状态的幸存者没有遵守推荐的筛查。放大了这个问题， 大多数儿童癌症幸存者不再在癌症中心接受跟踪，他们不知道自己的风险，而且 被初级保健提供者(PCP)跟踪，他们没有被告知建议的后续护理。 为了提高高危儿童癌症幸存者对结直肠癌筛查指南的依从性，我们 提出愿望(激活癌症幸存者和他们的初级保健提供者以增加结直肠癌 癌症筛查)研究，这是已知的第一个试图在这一领域提高CRC筛查率的干预措施 使用远程数字移动健康干预的人群。这是一项三组随机对照试验，以评估 在增加PCP激活和不增加PCP激活的情况下，患者激活对增加CRC筛查的效用。我们建议 将315名年龄至少30岁、有腹部或盆腔放射史的幸存者 儿童患癌症，无结直肠癌病史。 主要结果是在12个月内通过结肠镜或mt-sdna进行结直肠癌筛查。 学习期间。我们将确定(1)移动健康患者激活干预的相对有效性 (2)与对照组相比，患者激活+PCP激活。次要目标包括(1)开展 多利益攸关方混合方法实施研究综合框架(CFIR)--知情 评估以了解与接受干预相关的患者、提供者和系统因素，以 探索结直肠癌筛查的推动者和障碍，并为未来提供建议 适应、可伸缩性和可持续性；(2)确定采用CRC的潜在调节因素和中介因素 筛查；以及(2)估计干预措施的成本效益。 拟议的Asires研究汇集了一支拥有必要专业知识和经验的研究团队 在生存、CRC筛查、传播和实施以及mHealth干预研究中 由31个机构组成的儿童癌症幸存者研究(CCSS)的独特资源。值得注意的是，CCSS代表 目标人群和基础设施中单一最大的幸存者队列，以开展拟议的 学习。这项干预的结果将对结直肠癌的高危患者和我们 预期这项研究的结果将为实施和传播我们的《儿童权利公约》提供证据。 筛选针对这些人群的干预措施。

Project Summary Childhood cancer survivors treated with abdominal or pelvic radiotherapy (RT) are almost four times more likely to develop colorectal cancer (CRC) compared to the general population with their elevated risk evident by the age of 30 years with no plateau. Since earlier detection of precancerous lesions (i.e. adenomas) or CRC is strongly associated with improved survival, screening with colonoscopy or multitarget stool DNA testing (mt- sDNA) with a colonoscopy after a positive test is recommended starting at age 30. Unfortunately, the vast majority of survivors at high-risk for CRC are not adherent to recommended screening. Magnifying this problem, most childhood cancer survivors are no longer followed at a cancer center, are unaware of their risks and are being followed by primary care providers (PCPs) who are not informed about the recommended follow-up care. In order to improve adherence to CRC screening guidelines in high-risk childhood cancer survivors, we propose the ASPIRES (Activating cancer Survivors and their Primary care providers to Increase coloREctal cancer Screening) Study, which is the first known intervention to attempt to increase CRC screening rates in this population using a remote digital mHealth intervention. This is a 3-arm randomized controlled trial to evaluate the utility of patient activation with and without added PCP activation to increase CRC screening. We propose to randomize 315 survivors, who are at least 30 years of age, with a history of abdominal or pelvic radiation for a childhood cancer and without a history of CRC. The primary outcome is obtaining CRC screening with colonoscopy or mt-sDNA during the 12-month study period. We will determine the comparative effectiveness of (1) a mHealth patient activation intervention and (2) patient activation plus PCP activation, compared to control. Secondary aims include (1) conducting a multi-stakeholder mixed-methods Consolidated Framework for Implementation Research (CFIR)-informed evaluation to understand patient, provider and system factors associated with uptake of the intervention, to explore enablers and barriers to uptake of CRC screening, and to generate recommendations for future adaptation, scalability and sustainability; (2) identify potential moderators and mediators of uptake of CRC screening; and (2) estimate the cost-effectiveness of the intervention. The proposed ASPIRES Study brings together a research team with necessary expertise and experience in survivorship, CRC screening, dissemination and implementation, and mHealth intervention research with the unique resource of the 31-institution Childhood Cancer Survivor Study (CCSS). Notably, the CCSS represents the single largest cohort of survivors in the target population and the infrastructure to conduct the proposed study. Results from this intervention will have important implications for patients at high-risk for CRC and we expect that findings from this study will provide the evidence for implementation and dissemination of our CRC screening interventions targeting these populations.