Abstract Objective Colorectal cancer (CRC) is the second leading cause of cancer death in the US. Screening has decreased CRC mortality. However, disadvantaged patients, particularly those with mental illness or substance use disorder (SUD), are less likely to be screened. The aim of this trial was to evaluate the impact of a patient navigation program on CRC screening in patients with mental illness and/or SUD. Methods A pilot randomized nonblinded controlled trial was conducted from January to June 2017 in an urban community health center serving a low-income population. We randomized 251 patients aged 50–74 years with mental illness and/or SUD diagnosis overdue for CRC screening to intervention (n = 126) or usual care (n = 125) stratified by mental illness, SUD, or dual diagnosis. Intervention group patients received a letter followed by a phone call from patient navigators. Navigators helped patients overcome their individual barriers to CRC screening including: education, scheduling, explanation of bowel preparation, lack of transportation or accompaniment to appointments. If patient refused colonoscopy, navigators offered fecal occult blood testing. The main measure was proportion of patients completing CRC screening in intervention and usual care groups. Results Navigators contacted 85 patients (67%) in the intervention group and 26 declined to participate. In intention-to treat analysis, more patients in the intervention group received CRC screening than in the usual care group, 19% versus 10.4% (p = .04). Among 56 intervention patients who received navigation, 19 completed screening (33.9% versus 10.4% in the control group, p = .001). In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group (p = .05). Conclusions A patient navigation program improved CRC screening rates in patients with mental illness and/or SUD. Larger studies in diverse care settings are needed to demonstrate generalizability and explore which modality of CRC screening is most acceptable and which navigator activities are most effective for this vulnerable population. Trials Registration Number 2016P001322

中文翻译：

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精神疾病和/或物质使用障碍患者的结直肠癌筛查患者导航：试点随机对照试验

摘要 目的结直肠癌 (CRC) 是美国癌症死亡的第二大原因。筛查降低了 CRC 死亡率。然而，弱势患者，尤其是那些患有精神疾病或物质使用障碍 (SUD) 的患者，不太可能接受筛查。该试验的目的是评估患者导航计划对精神疾病和/或 SUD 患者 CRC 筛查的影响。方法 2017 年 1 月至 6 月在为低收入人群服务的城市社区卫生中心进行了一项随机非盲对照试验。我们将 251 名年龄在 50-74 岁的患有精神疾病和/或 SUD 诊断逾期进行 CRC 筛查的患者随机分配到干预 (n = 126) 或常规护理 (n = 125)，并按精神疾病、SUD 或双重诊断分层。干预组患者收到一封信，然后是患者导航员的电话。Navigators 帮助患者克服了他们进行 CRC 筛查的个人障碍，包括：教育、日程安排、肠道准备的解释、缺乏交通工具或预约陪同。如果患者拒绝结肠镜检查，导航员会提供粪便潜血检测。主要衡量指标是在干预组和常规护理组中完成 CRC 筛查的患者比例。结果 Navigators 联系了干预组的 85 名患者 (67%)，26 名拒绝参与。在意向治疗分析中，干预组接受 CRC 筛查的患者多于常规治疗组，分别为 19% 和 10.4% (p = .04)。在接受导航的 56 名干预患者中，19 名完成了筛查（33.9% 对 10. 4% 的对照组，p = .001）。在 SUD 患者亚组中，干预组中 20% 的患者接受了筛查，而常规护理组中则没有进行筛查 (p = .05)。结论 患者导航计划提高了精神疾病和/或 SUD 患者的 CRC 筛查率。需要在不同的护理环境中进行更大规模的研究，以证明其普遍性，并探索哪种 CRC 筛查方式最容易被接受，以及哪种导航活动对这一弱势群体最有效。试验注册号 2016P001322 需要在不同的护理环境中进行更大规模的研究，以证明其普遍性，并探索哪种 CRC 筛查方式最容易被接受，以及哪种导航活动对这一弱势群体最有效。试验注册号 2016P001322 需要在不同的护理环境中进行更大规模的研究，以证明其普遍性，并探索哪种 CRC 筛查方式最容易被接受，以及哪种导航活动对这一弱势群体最有效。试验注册号 2016P001322