A Targeted Decision Aid to Improve Minority Participation in Clinical Trials

描述（由申请人提供）：随机临床试验是评估医疗干预措施的金标准。然而，招募患者，特别是少数族裔患者参加试验往往很困难。缓慢和无代表性的试验累积延迟了新疗法的评估和引进，增加了成本，并降低了试验的普遍性。尽管越来越多的项目和网站提供临床试验的信息（两个例子是美国国立卫生研究院临床试验教育系列网站和美国国家医学协会的I.M.P.A.C.T.项目（增加少数群体参与和临床试验意识）），但在提高少数群体参与方面进展甚微。因此，我们认为需要一种新颖的方法，针对少数群体的具体问题和知识需求，并授权他们亲自考虑，然后与他们的医生参与试验进行讨论。在拟议的研究中，我们通过开发针对少数民族个体的临床试验参与决策援助（DA），直接解决临床试验中少数民族参与率低的问题。决策辅助（DAs）已广泛和成功地应用于治疗和筛查情况。一项对DA试验的系统回顾表明，与未接受DA的患者相比，接受DA的患者对选择和结果有更高的了解，更现实的期望，更少的决策困难，更积极地参与决策。然而，尽管参与临床试验的决定对个人来说是最困难和最复杂的医疗保健决定之一，但以前几乎没有关于参与临床试验的决策辅助的工作。我们认为，通过提供设计良好、对文化敏感的决策援助，将增加对临床试验的参与，特别是对少数民族的参与。因此，我们本研究的目标是开发和测试用于临床试验的少数靶向DA的有效性。具体而言，我们的目标是：目标1：通过整合非裔美国癌症幸存者和/或家庭成员的定性访谈信息、系统文献综述和最近完成的癌症临床试验参与研究，建立一个关于参与试验的态度、障碍和促进因素的综合数据库。目标2：开发有针对性的基于网络的英语和西班牙语决策辅助工具，其目标是：a)以可理解的方式提供有关临床试验的信息，b)提高患者与医疗保健提供者讨论试验的自我效能感，以及c)帮助患者澄清他们对参与试验的益处和风险的信念/价值观。目的3：探讨该决定对西班牙裔和非裔美国癌症幸存者及其家庭成员的疗效、有用性和影响。拟议的研究将开发一种有针对性的决策辅助，旨在提高参与，特别是提高少数民族参与广泛的临床试验。更有效和更具代表性的招募意味着临床试验可以更及时地积累参与者，从而可以更有效地获得有关新疗法和治疗方法有效性的结果。因此，拟议的研究将对临床试验研究界产生广泛的影响，从而使整个患者群体受益于新开发的治疗和疗法。

DESCRIPTION (provided by applicant): Randomized clinical trials are the gold standard for evaluation of medical interventions. However, recruitment of patients, particularly minorities, into trials is often difficult. Slow and non-representative trial accrual delays the assessment and introduction of new treatments, increases the cost, and reduces the generalizability of trials. Despite a growing number of programs and websites are providing information on clinical trials (two examples are the National Institutes of Health Clinical Trials Education Series website, and the National Medical Association's Project I.M.P.A.C.T. (Increase Minority Participation and Awareness of Clinical Trials)), there has been little progress in improving minority participation. Thus, we believe that a novel approach, which targets the specific concerns and knowledge needs of minorities, and which empowers them to personally consider and then discuss with their physician participation in trials, is needed. In the proposed research, we directly address the problem of low minority participation rates in clinical trials through a development of a decision aid (DA) for participation in clinical trials that is targeted to minority individuals. Decision aids (DAs) have been widely and successfully used in treatment and screening situations. A systematic review of DA trials has shown that patients receiving DAs have a higher knowledge of options and outcomes, more realistic expectations, less difficulty in reaching a decision, and more active participation in decision making than individuals who do not receive the DA. However, despite the fact that decision to participate in clinical trials is one of the most difficult and complex health care decisions for individuals, almost no previous work as been done on decision aid for clinical trials participation. We believe that participation in clinical trials, particularly for minorities, will be increased by the availability of a well-design, culturally sensitive decision aid. Thus, our goal for this research is to develop and test for effectiveness a minority targeted DA for participation in clinical trials. Specifically our aims are: Aim 1: Assemble a comprehensive database on attitudes, barriers and facilitators of participation in trials through integration of information from qualitative interviews with African American cancer survivors and/or family members, a systematic literature review, and a recently completed study of cancer clinical trials participation. Aim 2: Develop a targeted web-based decision aid in English and Spanish that has as its goals: a) providing information about clinical trials in a comprehensible way, b) improving patient self-efficacy for discussing trials with health care providers, and c) helping patients clarify their beliefs/values regarding the benefits and risks of participating in a trial. Aim 3: Explore the efficacy, usefulness, and effects of the decision aid a population of Hispanic and African American cancer survivors and family members. The proposed research will develop a targeted decision aid that aims to improve participation and particularly improve minority participation in a wide range of clinical trials. More efficient and representative recruitment means that clinical trials can accrue participants in a more timely fashion, and thus results about the effectiveness of new treatments and therapies can be obtained more efficiently. Thus, the proposed research will have a wide reaching effect on the clinical trials research community, and consequently on entire populations of patients who will benefit from the newly developed treatments and therapies.