Improving Clinical System Communication to Increase Trial Offers to Cancer Patien

描述（由申请人提供）：癌症临床试验提供了最新的癌症治疗方法，并被描述为提供了最好的癌症治疗方法。然而，只有大约3%的癌症患者参加了临床试验。在少数民族、社会经济地位较低的人和老年人中，这一比例甚至更低。入选的主要障碍来自：患者（例如，对试验的负面看法和/或态度，增加的治疗费用），医生（例如，对招募患者相关的时间/精力的担忧，提供试验的不适），以及机构亚单位（例如，关于临床试验资格的沟通不良，未能为招募患者参加试验提供支持）。然而，这些障碍本身都不能充分解释为什么会出现入学率不足的情况。我们从过去十年的研究中了解到，如果他们的肿瘤学家向他们提供并推荐试验，大多数患者都会接受试验。本研究的目的是开发一种基于系统的干预措施，以增加提供给患者的数量，从而增加参加试验方案的患者数量。该团队之前的研究调查了患者和医生之间发生的沟通和融合问题；这个项目的重点是直接检查由于医生和机构亚单位（特别是癌症中心的临床试验办公室）之间的低整合而导致的低入学率的融合问题。我们建议测试双组分干预的可行性和有效性，在系统层面上，1)提高临床试验办公室（CTO）工作人员和医生之间关于临床试验的可用性和这些试验的患者资格标准的整合水平；2)为医生提供更大的支持，以减轻他们在提出和招募患者参加试验时增加的临床负担。我们将使用信息学来改善临床试验办公室和医生之间关于试验可获得性和资格标准的沟通，并使用临床试验研究护士来改善患者、医生和临床试验办公室工作人员之间关于试验入组和随后患者对试验方案的接受的信息流和沟通。我们将评估干预阶段的个人和累积影响。公共卫生相关性：本试点研究考察了临床水平干预的各个方面，以增加城市癌症中心不同种族/民族患者人群参加癌症临床试验的机会。目标是测试增加现有临床试验信息的数量和分布以及提供者和医疗保健人员之间患者资格的策略的有效性，以提高向患者提供试验的比率。我们期望我们的工作能够对临床试验提供给患者的过程和质量、临床试验的接受率和入组率以及癌症预防和治疗研究的进展产生深远的影响。

DESCRIPTION (provided by applicant): Cancer clinical trials provide access to the latest cancer treatments available and have been described as providing the best cancer treatments available. However, only about 3% of all cancer patients go on clinical trials. The percentages are even lower among minorities, people of lower socioeconomic status, and the elderly. Major barriers to enrollment come from: patients (e.g., negative perceptions of and/or attitudes toward trials, added treatment costs), physicians (e.g., concerns about the time/effort associated with enrolling patients, discomfort with offering trials), and institutional subunits (e.g., poor communication about clinical trial eligibility, failure to provide support for enrolling patients on trials). However, none of these barriers, by themselves, provides a sufficient explanation for why under-enrollment occurs. We have learned from our previous decade of research that the majority of patients accept enrollment into trials if their oncologists offer and recommend trials to them. The goal of this study is to develop a systems-based intervention to increase the numbers of offers made to patients in order to increase the number of patients enrolling onto trial protocols. Previous research by this team has examined the communication and convergence problems occurring between patients and physicians; this project is focused on directly examining the convergence problems leading to poor enrollment that are due to low integration between physicians and institutional subunits, specifically, the Clinical Trials Offices, at cancer centers. We propose to test the feasibility and efficacy of a two- component intervention that will, at the systems level, 1) increase the integration level between the Clinical Trials Office (CTO) staff and physicians about the availability of clinical trials and patient eligibility criteria for these trials and 2) provide greater support for physicians to ease their added clinical burden in presenting and enrolling patients onto trials. We will use informatics to improve communication between the clinical trial office and physicians regarding trial availability and eligibility criteria, and clinical trials research nurses to improve information flow and communication between and among patients, physicians, and clinical trials office staff regarding enrollment in trials and subsequent patient acceptance of trial protocols. We will evaluate the individual and cumulative impact of the phases of the intervention. PUBLIC HEALTH RELEVANCE: This pilot research examines aspects of a clinical level intervention to increase offers of enrollment into cancer clinical trials to a racially/ethnically diverse patient population at an urban cancer center. The goal is to test the effectiveness of strategies that increase the amount and distribution of information about available clinical trials and patient eligibility among providers and healthcare staff in increasing rates of trial offers to patients. We anticipate our work to have a profound impact on the process and quality of clinical trial offers made to patients, the rates of clinical trial acceptance and enrollment and the advancement of cancer prevention and treatment research.