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

• 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
• 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

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 接受腹部或盆腔放疗（RT）的儿童癌症幸存者几乎是接受放疗的儿童的四倍。 与一般人群相比，可能发生结直肠癌（CRC）的风险升高， 30岁以上无高原期。由于癌前病变（即腺瘤）或CRC的早期检测， 与提高生存率、结肠镜筛查或多靶粪便DNA检测（mt- sDNA）与结肠镜检查后，阳性测试建议从30岁开始。不幸的是， 大多数CRC高危幸存者不遵守推荐的筛查。放大这个问题， 大多数儿童癌症幸存者不再在癌症中心接受随访，不知道他们的风险， 被初级保健提供者（PCP）跟踪，他们不知道推荐的后续护理。 为了提高高危儿童癌症幸存者对CRC筛查指南的依从性，我们 提出ASPIRES（激活癌症幸存者及其初级保健提供者，以增加结肠直肠 癌症筛查）研究，这是第一个已知的干预措施，试图提高CRC筛查率， 使用远程数字移动健康干预的人群。这是一项3组随机对照试验， 在有和没有添加PCP活化的情况下，患者活化对增加CRC筛查的效用。我们建议 随机选择315名至少30岁的幸存者，他们有腹部或盆腔放射史， 儿童癌症，无CRC病史。 主要结果是在12个月内通过结肠镜检查或mt-sDNA进行CRC筛查 学习期间。我们将确定（1）移动健康患者激活干预的比较有效性 和（2）与对照相比，患者激活加PCP激活。第二个目标包括：（1）开展 执行研究综合框架-知情 评估以了解与介入治疗相关的患者、提供者和系统因素， 探索推动因素和障碍，以吸收CRC筛查，并产生建议，为未来 适应性，可扩展性和可持续性;（2）确定潜在的调解人和调解人的吸收CRC 筛查;（2）评估干预措施的成本效益。 拟议的ASPIRES研究汇集了一个具有必要专业知识和经验的研究小组 在生存率，CRC筛查，传播和实施，以及移动健康干预研究方面， 儿童癌症幸存者研究（CCSS）的31个机构的独特资源。值得注意的是，CCSS代表了 目标人群中最大的一批幸存者，以及开展拟议的 study.这项干预的结果将对CRC高危患者产生重要影响， 我希望这项研究的结果将为我们的《儿童权利公约》的实施和传播提供证据 筛选针对这些人群的干预措施。