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

一项 I 型混合有效性实施试验，用于评估基于导航的多级干预措施，以减少头颈癌患者开始辅助治疗的延迟

• 批准号: 10714537
• 负责人: Evan Michael Graboyes
• 金额: $ 75.17万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10714537
• 关键词: Address; Adjuvant Radiotherapy; Adjuvant Therapy; Administrator; Affect; Behavior; Breast; Cancer Center; Caring; Cessation of life; Clinical; Cluster randomized trial; Colon; Communication; Data; Disease; Disparity; Effectiveness; Equity; Guidelines; Head and Neck Cancer; Head and Neck Surgery; Health behavior; Hybrids; Immunotherapy; Intervention; Interview; Knowledge; Lung; Malignant Neoplasms; Methods; Multicenter Trials; National Comprehensive Cancer Network; Operative Surgical Procedures; Outcome; Pathway interactions; Patients; Performance; Population; Postoperative Period; Process; Provider; Publishing; Radiation; Radiation therapy; Randomized; Recommendation; Referral and Consultation; Site; Social support; Structure; Surgeon; System; Translating; Work; arm; black patient; cancer care; cancer therapy; cancer type; care coordination; care delivery; chemotherapy; clinical care; clinical practice; effective therapy; effectiveness evaluation; effectiveness testing; effectiveness/implementation study; effectiveness/implementation trial; evidence base; implementation outcomes; improved; mortality disparity; mortality risk; multidisciplinary; racial disparity; racial minority; randomized trial; standard of care; survival disparity; treatment as usual

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.

项目总结/摘要 R 01提案旨在测试基于导航的 多层次的干预，以改善提供及时，公平，遵循指南的辅助治疗， 头颈癌（HNC）患者。HNC是一种生存率低且存在严重种族差异的疾病 死亡率。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周内进行，以优化生存率。然而，延迟启动遵循指南的端口（即，> 6 手术后10周）影响约50%的HNC患者和近70%的HNC黑人患者，因此 这是造成生存率低和死亡率种族差异的关键因素。到目前为止，改善儿童保健服务提供的干预措施， 在HNC患者中缺乏及时、公平的遵循指南的PORT。为了弥补这一差距，我们 开发了ENDURE（增强型差异和不适时辐射治疗导航）作为导航- 基于多层次的干预，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，团队和组织层面的障碍，从而改善交付 HNC术后及时、公平的PORT。我们的单组和初步随机试验的数据提供了 NDURE的可行性、可接受性和初步有效性的证据，以及时改善指南- 遵守港口和减少种族差异的延误。以这些有希望的数据为基础， ENDURE的实施在不同的设置，我们提出了一个混合类型1的有效性，实施 study.我们将在n = 4个癌症中心（N = 484例患者）进行一项阶梯楔形分组随机试验 随机分配至接受常规治疗（TAU）和ENDURE的HNC患者 手术和端口。同时，我们将进行一项定量评估的混合方法研究 辅以对患者、提供者和管理者的半结构化访谈， 执行Endure。具体目标1将评估ENDURE在减少延误方面的有效性 启动与TAU相关的符合指南的PORT。具体目标2将确定机制， ENDURE减少治疗延迟。具体目标3将描述ENDURE的实施情况， 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。一、成果 可能支持ENDURE作为第一个循证策略，以减少延迟开始辅助治疗， HNC患者这样的结果可能有助于改变目前的护理标准，提高生存率，并减少 这些患者死亡率的种族差异。其次，研究结果解决了一个研究不足但关键的方面， 癌症护理递送并且可以转化为其它类型的癌症（例如，乳腺、结肠、肺）， 开始辅助治疗是常见的。第三，机制数据可以提供可操作的知识来改进 提供有效的跨专业团队癌症护理。