Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health, 1501 Kings Highway, Shreveport, LA 71130, United States of America.
Grambling State University, 403 Main Street, GSU Box 4267, Grambling, LA 71245, United States of America.
Contemp Clin Trials. 2022 Feb;113:106654. doi: 10.1016/j.cct.2021.106654. Epub 2021 Dec 11.
Colorectal cancer (CRC) screening has been shown to decrease CRC mortality, yet significant disparities persist among those living in rural areas, from minority backgrounds, and those having low income. The purpose of this two-arm randomized controlled trial is to test the effectiveness and fidelity of a stepped care (increasing intensity as needed) approach to promoting 3-year adherence to CRC screening via fecal immunochemical testing (FIT) or colonoscopy in rural community clinics serving high rates of low-income and minority patients. We hypothesize that, compared to enhanced usual care (EUC), patients receiving the multifaceted CRC screening intervention will demonstrate higher rates of CRC screening completion over 3 years. Participants from six federally qualified health centers (FQHCs; N = 1200 patients) serving predominately low-income populations in rural Louisiana will be randomized to the intervention or EUC arm. All participants will receive health literacy-directed CRC counseling, simplified materials about both the FIT and colonoscopy procedures, and motivational interviewing to aid in the determination of test preference. Participants in the intervention arm will also receive motivational reminder messages from their primary care provider (via audio recording or tailored text) for either a scheduled colonoscopy or return of a completed FIT. Participants in the EUC arm will receive the standard follow-up provided by their clinic or colonoscopy facility. The primary outcome will be completion of either colonoscopy or annual FIT over 3 years. Results will provide evidence on the effectiveness of the intervention to decrease disparities in CRC screening completion related to health literacy, race, and gender. Trial registration:Clinicaltrials.gov Identifier NCT04313114.
结直肠癌（CRC）筛查已被证明可以降低 CRC 的死亡率，但在居住在农村地区、少数民族背景和低收入人群中，仍存在显著的差异。本两臂随机对照试验的目的是测试一种分级护理（根据需要增加护理强度）方法的有效性和保真度，该方法通过粪便免疫化学检测（FIT）或结肠镜检查，促进农村社区诊所中 3 年 CRC 筛查的依从性，这些诊所服务的低收入和少数民族患者比例较高。我们假设，与增强的常规护理（EUC）相比，接受多方面 CRC 筛查干预的患者在 3 年内完成 CRC 筛查的比例会更高。来自路易斯安那州农村地区的六个符合联邦资格的医疗中心（FQHCs；N=1200 名患者）的参与者将随机分配到干预组或 EUC 组。所有参与者将接受以健康素养为导向的 CRC 咨询，有关 FIT 和结肠镜检查程序的简化材料，以及动机访谈，以帮助确定测试偏好。干预组的参与者还将收到他们的初级保健提供者的动机提醒信息（通过音频记录或定制文本），以进行预定的结肠镜检查或返回已完成的 FIT。EUC 组的参与者将接受他们的诊所或结肠镜检查机构提供的标准随访。主要结果将是在 3 年内完成结肠镜检查或每年进行 FIT。研究结果将提供有关该干预措施减少与健康素养、种族和性别相关的 CRC 筛查完成率差异的有效性的证据。试验注册：Clinicaltrials.gov 标识符 NCT04313114。
