Clincal Trials Education for Hispanics

描述（由申请人提供）：西班牙裔美国人（HA）血统的男性和女性很难招募到临床试验中。造成这种情况的因素有多种，包括与个人的社会经济和语言特点有关的获得保健和健康教育的机会不同，在这一文化群体内相互作用的独特环境和社会力量，以及在与健康和疾病有关的态度、责任和做法方面的文化差异。NCI开发了一个定制的西班牙语HA临床试验教育系列（CTES），以帮助解决招募HA参与者参加临床试验的困难。然而，该系列尚未对其有效性进行系统评估，焦点小组发现它对于外行受众应用来说过于复杂。作为回应，fotonovelas被开发出来，但缺乏促进知识，态度和行为转变所需的内容。该项目将适应CTES的最佳方案组成部分到一个单一的 语言和文化一致的英语和西班牙语临床试验教育计划。这一适应性方案将作为随机对照试验的核心，以评估该方案的能力，以帮助提高HA的科学素养和积极改变他们对临床试验参与干预组的态度，然后评估是否增加科学素养和改善态度，在该组调解随后的响应邀请参加研究。他们的回答将与对照组成员在识字和态度方面的变化以及对相同研究邀请的反应进行比较。此外，还将比较干预组与对照组受试者对邀请参加PI的临床试验大使计划（ACTP）的反应（ACTP通过让大使帮助研究招募其社区的其他成员来促进参与研究）。基线数据收集还将包括经验证的人口统计学、健康、文化和心理社会工具，以使研究人员能够确定参与者的个人特征是否对临床试验教育计划有中度反应。总体研究目标是确定NCI的教育计划是否可以调整并应用于开始在HA社区内与临床试验参与相关的知识、态度和行为转变的过程。如果这项教育计划是有效的，将有一个直接和长期的公共卫生效益。该计划将有 在医管局社区内对参与研究的知识和态度产生积极转变的即时效果。这将使该地区的研究界受益，因为它建立了一个医管局社区成员库，这些成员可以直接被邀请参加研究，并可以帮助打开社区对研究界的大门。最终，这将促进医管局社区的健康和福祉，因为更多参与健康研究会增加研究结果对这一社区的普遍性。

DESCRIPTION (provided by applicant): Men and women of Hispanic American (HA) heritage are difficult to recruit to clinical trials. Multiple factors contribute to this circumstance, including differential access to health care and health education associated with individuals' socioeconomic and linguistic characteristics, unique environmental and social forces that interplay within this cultural group, and cultural differences in attitudes, responsibilities, and practices related to health and disease. The NCI developed a customized Clinical Trials Education Series for HAs (CTES) in Spanish to help address the difficulty of recruiting HA participants to clinical trials. However, this series has not been systematically evaluated for its efficacy, and focus groups found it to be too complex for lay audience applications. In response, fotonovelas were developed but lack content needed to promote shifts in knowledge, attitudes, and behaviors. This project will adapt the best program components of the CTES into a single linguistically- and culturally-aligned clinical trials education program in English and Spanish. This adapted program will serve as the centerpiece of a randomized controlled trial to assess the program's capacity to help raise HAs' scientific literacy and positively change their attitudes about clinical trials participation in the intervention group, and then to assess whether the increased scientific literacy and improved attitudes in that group mediate subsequent response to invitations to participate in research studies. Their responses will be compared to control group members' changes in literacy and attitudes, and responses to the same research study invitations. In addition, intervention versus control participants' responsiveness to an invitation to participate in the PI's Ambassadors for Clinical Trials Program (ACTP) will be compared (ACTP promotes participation in research studies by having Ambassadors help studies recruit other members of their community). Baseline data collection will also include validated demographic, health, cultural, and psychosocial instruments to allow the researchers to determine whether personal characteristics of the participants moderate response to the clinical trials education program. The overarching study goal is to determine whether the NCI's education program can be adapted and applied to begin the process of creating a shift in knowledge, attitudes, and behaviors within the HA community related to clinical trials participation. If this educational program is effective, there will be an immediate and long term public health benefit. The program will have the immediate effect of creating a positive shift in knowledge and attitudes toward research study participation within the HA community. This will subsequently benefit the region's research community by creating a pool of HA community members who can be directly invited to participate in research studies and who can help open the community's doors to the research community. Ultimately this will advance the health and well being of the HA community as greater participation in health research increases the generalizability of research findings to this community.