A Type I Hybrid Effectiveness-Implementation Trial to Evaluate a Navigation-Based Multilevel Intervention to Decrease Delays Starting Adjuvant Therapy Among Patients with Head and Neck Cancer

项目摘要/摘要 本R01提案旨在测试以导航为基础的 多层次干预，以改善及时、公平、遵守指南的辅助治疗的提供 头颈癌患者(HNC)。HNC是一种存活率低、种族差异大的疾病 在死亡率方面。对于局部晚期HNC，指南建议开始术后放射治疗(PORT) 在手术后6周内，以优化生存。但是，延迟启动遵循准则的端口(即&gt；6 手术后几周)影响约50%的HNC患者和近70%的HNC黑人患者，因此 这是造成存活率低和死亡率种族差异的主要原因。到目前为止，改善交付情况的干预措施 HNC患者缺乏及时、公平的指南依从性端口。为了解决这一差距，我们 开发的耐久(针对差异和不及时的放射治疗的增强导航)作为导航- 基于多层次干预，改变癌症的结构、护理提供途径和行为 护理多团队系统，以解决患者、团队和组织级别的障碍，从而改进交付 HNC手术后及时、公平的端口。来自我们的单臂和飞行员随机试验的数据提供 Ndure在改进及时指南方面的可行性、可接受性和初步有效性的证据- 坚守港口和减少延误方面的种族差距。以这些有希望的数据为基础并描述 在不同环境下的实施，我们提出了一种混合类型1的有效性-实施 学习。我们将对n=4个癌症中心(N=484名患者)进行阶梯式楔形整群随机试验 随机按顺序给予照常治疗(TAU)，然后耐受到接受HNC治疗的患者 外科和港口。同时，我们将进行混合方法研究，并进行量化评估 辅以对患者、提供者和管理人员的半结构化采访，以确定 实施“忍耐”。具体目标1将评估在减少延误时忍耐的有效性 起始指南-与TAU相关的遵守端口。具体目标2将确定通过哪些机制 耐受性可减少治疗延误。具体目标3将描述执行耐受横跨 不同的临床环境。我们提案的结果有可能解决三个重要差距。第一，结果 可支持耐久作为第一个基于证据的策略，以减少开始辅助治疗的延迟 高血压性鼻炎患者。这样的结果可能有助于改变目前的护理标准，提高存活率，减少 这些患者的死亡率存在种族差异。第二，研究结果解决了一个未被充分研究但却很关键的方面 癌症护理服务的提供，并可能转化为其他类型的癌症(例如，乳腺癌、结肠癌、肺癌)，因此延迟 启动辅助治疗是很常见的。第三，机制数据可以提供可操作的知识，以改进 提供有效的跨专业团队癌症护理。

PROJECT SUMMARY/ABSTRACT This R01 proposal aims to test the effectiveness, mechanism, and implementation of a navigation-based multilevel intervention to improve the delivery of timely, equitable, guideline-adherent adjuvant therapy among patients with head and neck cancer (HNC). HNC is a disease with poor survival and profound racial disparities in mortality. For locally advanced HNC, guidelines recommend initiating postoperative radiation therapy (PORT) within 6-weeks of surgery to optimize survival. However, delays starting guideline-adherent PORT (i.e., > 6 weeks after surgery) affect ~50% of patients with HNC and nearly 70% of Black patients with HNC and are thus a key driver of poor survival and racial disparities in mortality. To date, interventions that improve the delivery of timely, equitable guideline-adherent PORT among patients with HNC are lacking. To address this gap, we developed ENDURE (Enhanced Navigation for Disparities and Untimely Radiation thErapy) as a navigation- based multilevel intervention that modifies the structure, care delivery pathways, and behaviors of the cancer care multiteam system to address patient-, team-, and organization-level barriers and thus improve the delivery of timely, equitable PORT following surgery for HNC. Data from our single-arm and pilot randomized trial provide evidence of NDURE’s feasibility, acceptability, and preliminary effectiveness at improving timely guideline- adherent PORT and decreasing racial disparities in delays. To build on these promising data and characterize ENDURE’s implementation across diverse settings, we propose a hybrid type 1 effectiveness-implementation study. We will conduct a stepped wedge cluster randomized trial with n = 4 cancer centers (N = 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with HNC undergoing surgery and PORT. Concurrently, we will conduct a mixed-methods study with quantitative assessments supplemented by semi-structured interviews of patients, providers, and administrators to characterize the implementation of ENDURE. Specific Aim 1 will evaluate the effectiveness of ENDURE at decreasing delays starting guideline-adherent PORT relative to TAU. Specific Aim 2 will identify the mechanisms through which ENDURE reduces treatment delays. Specific Aim 3 will characterize the implementation of ENDURE across diverse clinical settings. Findings from our proposal have potential to address three important gaps. First, results may support ENDURE as the first evidence-based strategy to decrease delays starting adjuvant therapy for patients with HNC. Such a result may help change the current standard of care, improve survival, and decrease racial disparities in mortality for these patients. Second, findings address an understudied but critical aspect of cancer care delivery and could be translated to other types of cancer (e.g., breast, colon, lung) for which delays initiating adjuvant therapy are common. Third, mechanism data may provide actionable knowledge to improve the delivery of effective interprofessional team-based cancer care.