Pragmatic Trial

摘要--实用的临床试验 癌症危险行为，包括吸烟、缺乏运动和肥胖，分别与 减少治疗反应、副作用、增加复发风险、缩短寿命、降低质量 寿命延长，许多癌症的治疗费用增加。这些行为至少在 癌症患者和幸存者与健康成年人一样，但治疗他们的转诊途径并不常见 整合到癌症护理中。通过将癌症风险行为评估集成到电子健康记录中 在电子病历系统(EHR)和自动化治疗转诊方面，我们计划使健康风险的远程医疗成为可能 行为(一种称为健康促进的临床服务)，癌症提供者和患者在整个过程中都可以获得 该中心的临床实践网络以一种负担得起、提高护理质量和最低限度的方式 扰乱现有的临床工作流程。我们在实施患者报告结果评估方面的成功 以及EHR支持的戒烟、促进体力活动和肥胖行为干预 将这些服务整合到整个西北医学(NM)肿瘤护理中，这是我们的独特定位 与面对面计划相比，系统使用的资源相对较少。我们建议在现有的基础上 NCI资助的戒烟和症状监测项目，通过以下方式完全融入癌症：1) 增加对健康危险行为的简单筛查；2)扩大现有的吸烟自动转介系统，以 包括转介至专门针对癌症的健康促进服务，其中包括不活动和肥胖治疗；以及 3)完善症状监测仪表板，将吸烟、缺乏运动和肥胖纳入其中。《中心》 将部署一项双臂实用临床试验，比较为期12个月的远程健康干预对肥胖、体力活动的影响 不活动和烟草使用与加强的日常护理控制条件相比。参与者(n=3000)将是 18岁或18岁以上的癌症幸存者，至少有一种癌症风险因素。治疗随机化 将根据主要危险行为、研究地点(西北纪念医院与其他NM医院)、 危险行为的数量(1、2或3)，以及癌症治疗(当前治疗与不治疗)。远程保健参与者 根据患者偏好，将收到20个英语或西班牙语电话或视频，具体如下 时间表：每周2个月，每隔一周4个月，每月2个月，每隔一个月 在最后4个月里。控制部门的参与者将收到一本小册子，其中载有地方/国家资源，以 解决他们的癌症风险行为，这些行为将通过邮件、电子邮件或MyChart消息发送，具体取决于 病人的喜好。评估将由评估员进行，治疗组盲目进行，在基线、3、6、9、 还有12个月。我们将评估治疗范围及其对行为、护理机会和质量的影响， 医疗保健利用率、成本、患者-提供商沟通和健康结果，这一严谨的 务实研究将广泛适用于不同的临床环境和患者群体，并做出贡献 为癌症护理中的远程医疗提供了实质性的证据基础，具有改变癌症护理的潜力。

Abstract - Pragmatic Clinical Trial Cancer risk behaviors, including smoking, physical inactivity, and obesity, are individually associated with reduced treatment response, side effects, heightened recurrence risk, decreased longevity, diminished quality of life, and increased treatment cost for many cancers. These behaviors are at least as prevalent among cancer patients and survivors as they are in healthy adults, but referral pathways to treat them are not routinely integrated into cancer care. By integrating cancer risk behavior assessment into the electronic health record system (EHR) and automating treatment referral, we plan to make telehealth-enabled treatment of health risk behaviors (a clinical service called health promotion) accessible to cancer providers and patients throughout the Center’s clinical practice network in a manner that is affordable, improves care quality, and is minimally disruptive to existing clinical workflow. Our success in implementing patient-reported outcomes assessments and EHR-supported smoking cessation, physical activity promotion, and obesity behavioral interventions uniquely position us to integrate these services across the entire Northwestern Medicine (NM) oncology care system using relatively few resources compared to in-person programs. We propose to build upon existing NCI-funded tobacco cessation and symptom monitoring programs that are fully integrated into cancer by: 1) adding brief screening for health risk behaviors, 2) augmenting the existing smoking auto-referral system to include referral to a cancer-specific health promotion service that includes inactivity and obesity treatment; and 3) refining the symptom monitoring dashboard to include smoking, physical inactivity, and obesity. The Center will deploy a 2-arm pragmatic clinical trial comparing a 12-month telehealth intervention for obesity, physical inactivity, and tobacco use versus an enhanced usual care control condition. Participants (n=3000) will be cancer survivors aged 18 or older who have at least one of the cancer risk factors. Treatment randomization will be stratified by primary risk behavior, study site (Northwestern Memorial Hospital vs other NM hospital), number of risk behaviors (1, 2 or 3), and cancer treatment (current treatment vs. not). Telehealth participants will receive 20 calls or videos in English or Spanish, per patient preference, according to the following schedule: weekly for 2 months, every other week for 4 months, monthly for 2 months, and every other month for the final 4 months. Participants in the control arm will receive a pamphlet with local/national resources to address their cancer risk behavior, which will be sent by either mail, email, or MyChart message depending on patient preference. Assessments will be conducted by assessors, blinded to treatment arm, at baseline, 3, 6, 9, and 12 months. We will evaluate treatment reach and its effects on the behaviors, care access and quality, healthcare utilization, cost, patient-provider communication, and health outcomes, Findings from this rigorous pragmatic study will be broadly applicable to diverse clinical settings and patient populations and contribute substantially to the evidence-base for telehealth in cancer care, with potential to transform cancer care.