Pragmatic Trial

务实试用

• 批准号: 10454619
• 负责人: Bonnie Spring
• 金额: $ 29.37万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10454619
• 关键词: Address; Adult; Attenuated; Behavior; Behavior Therapy; Behavior assessment; Blinded; Body mass index; COVID-19 pandemic; Cancer Hospital; Cancer Patient; Cancer Survivor; Characteristics; Clinic; Clinic Visits; Clinical; Clinical Services; Disease; Electronic Health Record; Electronic Mail; Ensure; Ethnic Origin; Funding; Goals; Guidelines; Health; Health Promotion; Health Services; Health Services Accessibility; Healthcare; Healthcare Systems; Hospitals; Individual; Intervention; Longevity; Malignant Neoplasms; Medical; Medicine; Monitor; Obesity; Oncologist; Oncology; Outcome; Outcome Assessment; Pamphlets; Participant; Pathway interactions; Patient Care; Patient Outcomes Assessments; Patient Preferences; Patients; Persons; Physical activity; Positioning Attribute; Pragmatic clinical trial; Process; Provider; Quality of Care; Quality of life; Race; Randomized; Readiness; Recording of previous events; Recurrence; Reporting; Research; Resources; Risk; Risk Behaviors; Risk Factors; Risk Reduction; Schedule; Second Primary Cancers; Services; Site; Smoking; Socioeconomic Status; Support System; Survivors; Symptoms; System; Time; Tobacco Use Cessation; Tobacco use; Transportation; Treatment Cost; United States Agency for Healthcare Research and Quality; adverse outcome; aged; arm; behavioral study; brief screening; cancer care; cancer clinical trial; cancer recurrence; cancer risk; cancer therapy; care systems; clinical center; clinical practice; comorbidity; cost; dashboard; efficacious intervention; evidence base; health care service utilization; healthy lifestyle; improved; mortality; novel; obese person; obesity treatment; patient population; patient-clinician communication; physical inactivity; pragmatic trial; programs; psychosocial; screening program; side effect; smoking cessation; success; telehealth; treatment arm; treatment as usual; treatment program; treatment response; trial comparing

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.

摘要 - 务实的临床试验 癌症风险行为，包括吸烟，身体不活跃和肥胖，与 减少治疗反应，副作用，复发风险的增长，寿命降低，质量降低 生活的生活，以及许多癌症的治疗成本。这些行为至少在 与健康成年人一样 整合到癌症护理中。通过将癌症风险行为评估整合到电子健康记录中 系统（EHR）和自动化治疗转介，我们计划对远程医疗的健康风险进行治疗 癌症提供者和患者可以使用行为（一种称为健康促进的临床服务） 该中心的临床实践网络以负担得起的方式提高了护理质量，并且最少 对现有临床工作流程的破坏。我们在实施患者报告的结果评估方面的成功 以及EHR支持的吸烟，促进体育锻炼和肥胖行为干预措施 独特地将我们定位在整个西北医学（NM）肿瘤护理中的整合 与面对面程序相比，系统使用相对较少的资源。我们建议以现有 NCI资助的戒烟和症状监测计划，这些程序已完全融入癌症：1） 对健康风险行为进行简短筛查，2）将现有的吸烟自发推荐系统增加到 包括转介到包括不活动和肥胖治疗的癌症特异性健康促进服务；和 3）完善症状监测仪表板以包括吸烟，身体不活跃和肥胖。中心 将部署一项2臂务实的临床试验，比较肥胖症的12个月远程医疗干预措施 不活动，烟草使用与增强的常规护理控制条件。参与者（n = 3000）将 至少有一个癌症危险因素之一的18岁或以上的癌症幸存者。治疗随机化 将通过主要风险行为，研究地点（西北纪念医院与其他NM医院）进行分层 风险行为的数量（1、2或3）和癌症治疗（当前治疗与非治疗方法）。远程医疗参与者 根据以下内容 时间表：每周2个月，每隔一周持续4个月，每月2个月，每隔一个月 最后四个月。控制部门的参与者将获得一名带有本地/国家资源的小册子 解决他们的癌症风险行为，该行为将通过邮件，电子邮件或Mychart消息发送 患者偏爱。评估者将由对治疗部门视而不见的评估者进行3、6、9，9， 和12个月。我们将评估治疗范围及其对行为，护理访问和质量的影响， 医疗保健利用，成本，患者提供的沟通和健康成果 务实的研究将广泛适用于潜水员的临床环境和患者人群，并贡献 基本上是癌症护理中远程医疗的证据基础，具有改变癌症护理的潜力。