Pragmatic Trial

摘要-实用的临床试验 癌症风险行为，包括吸烟，缺乏身体活动和肥胖，与以下因素单独相关： 治疗反应降低、副作用、复发风险增加、寿命缩短、质量下降 增加了许多癌症的治疗成本。这些行为至少在 癌症患者和幸存者，因为他们是在健康的成年人，但转诊途径，以治疗他们不是常规的 整合到癌症护理中。通过将癌症风险行为评估纳入电子健康记录 系统（EHR）和自动化治疗转诊，我们计划使远程医疗能够治疗健康风险 行为（一种称为健康促进的临床服务），癌症提供者和患者可以在整个 该中心的临床实践网络的方式是负担得起的，提高护理质量，并最低限度地 破坏现有临床工作流程。我们在实施患者报告结局评估方面的成功 和EHR支持的戒烟、体力活动促进和肥胖行为干预 使我们能够在整个西北医学（NM）肿瘤治疗中整合这些服务， 系统使用相对较少的资源相比，在人的节目。我们建议在现有基础上， NCI资助的戒烟和症状监测计划，通过以下方式完全融入癌症：1） 增加对健康风险行为的简要筛查，2）扩大现有的吸烟自动转诊系统， 包括转介到癌症特定的健康促进服务，包括不活动和肥胖治疗;以及 3)完善症状监测仪表板，包括吸烟，身体活动不足和肥胖。中心 将部署一项2臂实用临床试验，比较12个月的远程健康干预对肥胖，身体 不活动和烟草使用与增强的日常护理控制条件。参与者（n=3000）将 18岁或以上的癌症幸存者，至少有一种癌症风险因素。治疗随机化 将按主要风险行为、研究中心（西北纪念医院vs其他NM医院）进行分层， 风险行为的数量（1、2或3）和癌症治疗（当前治疗与未治疗）。远程保健参与者 根据以下内容，根据患者偏好，将收到20个英语或西班牙语电话或视频 时间表：每周一次，持续2个月，每隔一周一次，持续4个月，每月一次，持续2个月，每隔一个月一次 最后四个月。对照组的参与者将收到一份载有地方/国家资源的小册子， 解决他们的癌症风险行为，这将通过邮件，电子邮件或MyChart消息发送，具体取决于 患者偏好评估将由对治疗组设盲的评估者在基线、3、6、9、10、11、12、13、14、15、16、17、18、19 还有12个月我们将评估治疗范围及其对行为、护理可及性和质量的影响， 医疗保健利用率，成本，患者-提供者沟通和健康结果，这项严格的调查结果 务实的研究将广泛适用于不同的临床环境和患者人群，并有助于 这将在很大程度上为癌症护理中的远程保健提供证据基础，并有可能改变癌症护理。

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.