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.

项目概要/摘要 该R01提案旨在测试基于导航的有效性、机制和实施 多层次干预，以改善及时、公平、符合指南的辅助治疗 头颈癌（HNC）患者是一种生存率低且种族差异巨大的疾病。 对于局部晚期 HNC，指南建议开始术后放射治疗 (PORT)。 手术后 6 周内以优化生存，但延迟开始遵循指南的 PORT（即 > 6）。 手术后几周）影响约 50% 的 HNC 患者和近 70% 的黑人 HNC 患者，因此 迄今为止，改善提供服务的干预措施是导致生存率低下和种族死亡率差异的一个关键因素。 HNC 患者缺乏及时、公平且符合指南的 PORT 为了解决这一差距。 开发了 ENDURE（差异和不及时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 护理多团队系统可解决患者、团队和组织层面的障碍，从而改善交付 我们的单臂和试点随机试验提供了 HNC 手术后及时、公平的 PORT 的结果。 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 坚持 PORT 并减少延误方面的种族差异。以这些有希望的数据和特征为基础。 ENDURE 在不同环境中的实施，我们提出了一种混合类型 1 有效性实施 我们将在 n = 4 个癌症中心（N = 484 名患者）中进行阶梯式楔形集群随机试验。 随机顺序照常进行治疗 (TAU)，然后对接受治疗的 HNC 患者进行 ENDURE 同时，我们将进行一项定量评估的混合方法研究。 辅之以对患者、提供者和管理人员的半结构化访谈，以描述 具体目标 1 的实施将评估 ENDURE 在减少延误方面的有效性。 启动与 TAU 相关的遵循指南的 PORT 将确定其机制。 ENDURE 减少治疗延误 具体目标 3 将描述 ENDURE 的实施情况。 我们提案的不同临床环境有可能解决三个重要的差距。 可能支持 ENDURE 作为第一个基于证据的策略，以减少开始辅助治疗的延迟 这样的结果可能有助于改变当前的护理标准、提高生存率并降低死亡率。 其次，研究结果解决了一个尚未得到充分研究但至关重要的方面。 癌症护理服务，并可转化为其他类型的癌症（例如乳腺癌、结肠癌、肺癌），导致延迟 第三，机制数据可以提供可操作的知识来改善。 提供有效的跨专业团队癌症护理。