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

ASPIRES 研究：激活癌症幸存者及其初级保健提供者以加强结直肠癌筛查

基本信息

批准号：
10327669
负责人：
Tara Olive Henderson
金额：
$ 65.17万
依托单位：
UNIVERSITY OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-03-01 至 2026-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10327669
关键词：
Abdomen Adherence Adult Age Age-Years Cancer Center Cancer Survivor Cancer Survivorship Carcinoma Caring Childhood Cancer Survivor Study Childhood Cancer Treatment Chronic Disease Cohort Studies Colonoscopy Colorectal Cancer Consolidated Framework for Implementation Research DNA Detection Development Dissemination and Implementation Dose Early Diagnosis Education Effectiveness Effectiveness of Interventions Evaluation Exposure to Family history of Feces Future General Population Geography Goals Guidelines Health Services Accessibility Hybrids Infrastructure Institution Intervention Intervention Studies Lesion Life Long-Term Survivors Longterm Follow-up Malignant Childhood Neoplasm Malignant Neoplasms Mediator of activation protein Methods Morbidity - disease rate Patients Pediatric Oncology Group Pelvis Population Premature Mortality Primary Care Physician Provider Radiation Radiation therapy Randomized Randomized Controlled Trials Recommendation Recording of previous events Research Resources Risk Secondary to Survivors System Target Populations Testing Text Messaging Time Work adenoma arm care providers childhood cancer survivor cohort colorectal cancer risk colorectal cancer screening comparative effectiveness comparative efficacy cost estimate digital early onset colorectal cancer effectiveness evaluation effectiveness implementation study experience follow-up high risk implementation evaluation implementation process improved improved outcome incremental cost-effectiveness mHealth mortality premalignant primary outcome remote intervention screening screening guidelines survivorship therapy design uptake

项目摘要

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.

项目摘要用腹部或骨盆放射治疗（RT）治疗的儿童癌症幸存者几乎是四倍与普通人群相比 30岁，没有高原。由于早期发现癌前病变（即腺瘤）或CRC是与提高生存率，结肠镜检查或多坐鼠粪便DNA测试密切相关（MT- SDNA）建议在30岁开始进行阳性测试后结肠镜检查。不幸的是，庞大 CRC高风险的大多数幸存者都不遵守建议筛查。放大这个问题，大多数儿童癌症幸存者不再在癌症中心遵循，不知道自己的风险，并且是紧随其后的是未通知建议的后续护理的初级保健提供者（PCP）。为了提高对高危儿童癌症幸存者中CRC筛查指南的依从性，我们提出志向（激活癌症幸存者及其初级保健提供者以增加结直肠癌癌症筛查）研究，这是第一个试图提高CRC筛查率的已知干预措施人口使用远程数字MHealth干预措施。这是一项3臂随机对照试验，以评估随着有或没有添加的PCP激活，患者激活的效用以增加CRC筛查。我们建议将至少30岁的315个幸存者随机分配，具有腹部或骨盆辐射史儿童癌症，没有CRC史。主要结果是在12个月内用结肠镜检查或MT-SDNA获得CRC筛查研究期。我们将确定（1）MHealth患者激活干预的比较有效性（2）与对照相比，患者激活加PCP激活。次要目的包括（1）进行多方利益相关者混合方法合并实施研究（CFIR）的框架评估以了解与干预措施相关的患者，提供者和系统因素探索促进者和障碍，以吸收CRC筛查，并为将来提出建议适应性，可伸缩性和可持续性；（2）确定摄取CRC的潜在主持人和介体筛选；（2）估计干预的成本效益。拟议的愿望研究将一个具有必要专业知识和经验的研究团队汇集在一起在生存，CRC筛查，传播和实施以及MHealth干预研究中 31机构儿童癌症幸存者研究（CCSS）的独特资源。值得注意的是，CCSS代表目标人群中最大的幸存者队列和基础设施进行拟议学习。这种干预的结果将对CRC高风险患者具有重要意义，我们期望这项研究的发现将为我们的CRC实施和传播提供证据针对这些人群的筛查干预措施。