A Multilevel Intervention to Increase the Participation of African Americans in Prostate Cancer Clinical Trials

 描述（由申请人提供）：癌症临床试验对于将研究转化为患者的切实利益至关重要，但只有少数患者参加试验少数民族的招募不足是一个更大的问题，因为它限制了研究结果的普遍性并导致治疗差异。前列腺癌试验中的少数族裔入组不足尤其令人烦恼，因为与白色男性相比，非裔美国男性中这种癌症的发病率、发病率和死亡率更高。我们研究的总体目标是改善癌症护理，减少种族/民族癌症差异，方法是增加患有前列腺癌的非洲裔美国男性根据与医生的高质量沟通做出知情决定参加试验的比率。在这个应用程序中，我们提出了一个基于理论的多层次的干预，旨在影响非洲裔美国患者的态度，医生和试验;医生对患者和试验的态度;和患者提供者的临床互动中，可能会讨论试验。干预旨在改善这些结果：患者对试验的理解和参与决定;医生决定讨论和提供试验;患者与医生的沟通;最终，非裔美国人前列腺癌的参与率。我们的干预基于我们先前的研究，表明患者和医生的态度和信念往往导致临床访问期间没有讨论试验，或者当讨论试验时，沟通是无效的。这些因素在种族不一致的访视中甚至更大，可能导致非裔美国人的试验入组率较低。我们将在两个NCI指定的综合癌症中心进行拟议的研究，这些中心在城市地区提供护理。将纳入非裔美国人和白色男性，以便按患者种族比较干预的效果。干预有两个阶段。第1阶段是一项随机试验，其中干预组患者接受一种工具，以改善他们对试验的态度，并增加他们对可能讨论试验的临床访视的积极参与。第2阶段是一个中断的时间序列准实验，其中医生接受干预，以改善他们对试验的态度和他们在与患者讨论试验期间的沟通。数据将包括患者和医生的自我报告、患者-医生诊所访视的视频记录和医疗记录。我们提出了三个具体目标：1）确定干预措施的每个阶段对结果的独立和综合影响; 2）比较非裔美国人与白色男性干预措施对结果的影响; 3）检查患者-医生沟通在多大程度上介导了干预措施与结果之间的关系。这项研究是非常重要和创新的，因为它测试了一个新的概念模型，重点是病人，医生和临床互动，并使用社会心理学和沟通理论，以改善临床实践。研究结果应该为一种实用的、可输出的干预措施提供证据，以增加非裔美国男性前列腺癌患者的试验入组率。

 DESCRIPTION (provided by applicant): Cancer clinical trials are essential to translating research into tangible benefits for patients, but only a small number of patients enroll in a trial Under-enrollment of minorities is an even greater problem because it limits the generalizability of findings and contributes to treatment disparities. Minority under-enrollment in prostate cancer trials is especially troublesome because of the higher incidence, morbidity, and mortality of this cancer among African American men, as compared to White men. The overall goal of our research is to improve cancer care and reduce racial/ethnic cancer disparities by increasing rates at which African American men with prostate cancer make an informed decision to participate in a trial, based on high-quality communication with their physician. In this application, we propose a theory-based multilevel intervention designed to influence African-American patients' attitudes about physicians and about trials; physicians' attitudes about patients and about trials; and patient-provider clinical interactions in which trials may be discussed. The intervention is designed to improve these outcomes: patient understanding of trials and decisions to participate; physician decisions to discuss and offer trials; patient-physician communication; and ultimately, participation rates among African Americans with prostate cancer. We base the intervention on our prior research showing that patient and physician attitudes and beliefs often result in trials not being discussed during clinic visits, or when trials are discussed, communication is ineffective. These factors are even greater in racially discordant visits, and likely contribute to low trial enrollment among African Americans. We will conduct the proposed research at two NCI-designated comprehensive cancer centers that provide care in urban areas. African American and White men will be included to allow comparison of the effects of the intervention by patient race. The intervention has two phases. Phase 1 is a randomized trial in which intervention group patients receive a tool to improve their attitudes about trials and increase their active participation in clinic visits in which trials maybe discussed. Phase 2 is an interrupted time series quasi-experiment in which physicians receive an intervention to improve their attitudes about trials and their communication during discussions of trials with patients. Data will include patient and physician self-reports, video recordings of patient-physician clinic visits, and medical records. We propose three Specific Aims: 1) determine the independent and combined effects of each phase of the intervention on outcomes; 2) compare the effects of the intervention on outcomes for African American versus White men; and 3) examine the extent to which patient-physician communication mediates the relationship between the intervention and outcomes. This research is highly significant and innovative because it tests a new conceptual model focusing on patients, physicians, and clinical interactions, and uses social psychological and communication theory to improve clinical practice. Findings should provide evidence for a practical, exportable intervention to increase trial enrollment among African American men with prostate cancer.