Improving the Timeliness and Equity of Adjuvant Therapy Following Surgery for Head and Neck Cancer

提高头颈癌术后辅助治疗的及时性和公平性

• 批准号: 10016219
• 负责人: Evan Michael Graboyes
• 金额: $ 26.65万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-11 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10016219
• 关键词: Address; Adjuvant Therapy; Advanced Malignant Neoplasm; Affect; African American; Caring; Cessation of life; Clinical; Clinical Trials Design; Continuity of Patient Care; Data; Development; Disease; Division of Cancer Control and Population Sciences; Enrollment; Excess Mortality; Goals; Head and Neck Cancer; Head and Neck Surgery; Health system; Interpersonal Relations; Intervention; Intervention Studies; Interview; Knowledge; Lead; Logistics; Mentors; Modeling; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Patterns of Care; Pilot Projects; Population; Positioning Attribute; Postoperative Period; Process; Provider; Qualitative Research; Radiation; Radiation therapy; Randomized; Randomized Controlled Trials; Research; Scientist; Self Efficacy; Site; Surgeon; Testing; Time; Toxic effect; Training; Work; arm; base; cancer care; cancer health disparity; cancer surgery; cancer type; care coordination; care delivery; caucasian American; chemotherapy; clinical care; effective intervention; head and neck cancer patient; health disparity; implementation research; improved; informant; mortality; mortality disparity; multimodality; novel; patient population; prevent; primary outcome; programs; racial difference; racial disparity; satisfaction; screening; social health determinants; systems research; theories; therapeutic target; treatment as usual

PROJECT SUMMARY/ABSTRACT The goal of this K08 proposal is to provide the candidate with a framework to develop a comprehensive research program as a surgeon scientist investigating multi-level, theory-based interventions to improve the timeliness, equity, and quality of head and neck cancer (HNC) care delivery. HNC is a disease with poor survival despite intense therapy with surgery, radiation, and chemotherapy. HNC is also a disease with significant racial disparities in mortality; African Americans (AAs) have a 51% relative decrease in survival compared to whites. Delays starting postoperative radiation therapy (PORT) after HNC surgery are a key driver of high mortality and racial disparities in survival and thus an appealing therapeutic target to address both issues. Delayed, non- guideline-adherent PORT initiation affects 56% of HNC patients, is 31% more common in AAs, associated with an 11% absolute decrease in 5-year survival, and a key contributor to racial differences in mortality. Although delivering timely PORT is of critical importance to prevent excess mortality and racial disparities in survival, effective interventions to improve the rate of timely, equitable PORT are lacking, in part due to the gap in our understanding of the relevant barriers in this population. In this proposal, the candidate will develop, pilot-test, and evaluate the preliminary clinical impact of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based PN intervention to improve timely, equitable PORT in HNC patients. The research objective is to evaluate the preliminary clinical impact of NDURE on delays and racial disparities starting PORT among HNC patients. The central hypothesis is that NDURE will decrease PORT delays and racial disparities in delay by improving care coordination, self-efficacy, interpersonal support, and knowledge. Specific Aim 1 will identify the multi-level barriers that contribute to delays starting PORT after HNC surgery through key informant interviews with HNC patients and providers. Specific Aim 2 will assess the feasibility and acceptability of NDURE in a single-arm pilot study. Specific Aim 3 will test NDURE in a pilot randomized controlled trial (RCT) to evaluate its preliminary clinical impact on delays starting PORT among white and AA HNC patients. Ultimately, this research will have a large scientific impact by enhancing our conceptual understanding of timely, equitable multimodal HNC care delivery. It will have a significant clinical impact through the development of a scalable and practical intervention to decrease delays and racial disparities starting PORT, thereby improving survival for HNC patients and decreasing racial disparities in mortality. The training objective is to address the candidate’s scientific gaps in cancer health disparities, qualitative research, health systems and interventions research, and clinical trial design and analysis through mentored scientific training integrated and aligned with his research. Completion of the research and scientific training will position the candidate well to lead research investigating multi-level, theory-based interventions to improve the timeliness, equity, and quality of HNC care delivery.

项目总结/摘要 本K 08提案的目标是为候选人提供一个框架，以开展全面的研究 程序作为外科医生科学家调查多层次，基于理论的干预措施，以提高及时性， 公平性和头颈癌（HNC）护理服务的质量。HNC是一种生存率低的疾病， 用手术、放疗和化疗进行强化治疗。HNC也是一种具有显著种族差异的疾病， 死亡率的差异;与白人相比，非洲裔美国人（AAs）的生存率相对下降了51%。 HNC手术后延迟开始术后放射治疗（PORT）是高死亡率的关键驱动因素， 生存的种族差异，因此是解决这两个问题的有吸引力的治疗目标。延迟，非- 符合指南的PORT启动影响56%的HNC患者，在AA中更常见31%，与 5年生存率绝对下降11%，这是造成死亡率种族差异的关键因素。虽然 及时提供PORT对于防止过高的死亡率和生存中的种族差异至关重要， 缺乏有效的干预措施来提高及时、公平的PORT率，部分原因是我们在这方面存在差距。 了解这一人群的相关障碍。在本提案中，候选人将开发，试点测试， 并评估NDURE（差异和不适时辐射导航）的初步临床影响 thErapy），一种新的基于理论的PN干预，以改善HNC患者的及时，公平的PORT。的 研究目的是评估NDURE对延迟和种族差异的初步临床影响， HNC患者中的PORT。中心假设是NDURE将减少端口延迟和种族 通过改善护理协调、自我效能、人际支持和知识来减少延迟的差异。具体 目标1将通过以下关键因素识别导致HNC手术后延迟开始PORT的多层次障碍： 与HNC患者和提供者的线人访谈。具体目标2将评估可行性和可接受性 在一项单组初步研究中，具体目标3将在一项初步随机对照试验（RCT）中测试NDURE 评价其对白色和AA HNC患者延迟开始PORT的初步临床影响。最后， 这项研究将通过加强我们对及时、公平、公正的概念性理解， 多模式HNC护理提供。它将通过开发一种可扩展的， 采取实际干预措施，减少PORT启动的延误和种族差异，从而提高HNC的生存率 减少死亡率的种族差异。培训目标是解决候选人的 癌症健康差异、定性研究、卫生系统和干预措施研究方面的科学差距，以及 临床试验设计和分析，通过指导科学培训整合并与他的研究保持一致。 完成研究和科学培训将使候选人能够很好地领导研究调查 多层次、基于理论的干预措施，以提高HNC护理提供的及时性、公平性和质量。