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很多，包括与个人的社会经济和语言特征有关的获得保健和健康教育的机会不同，在这一文化群体中相互作用的独特环境和社会力量，以及与健康和疾病有关的态度、责任和做法的文化差异。NCI用西班牙语为HAS开发了定制的临床试验教育系列(CTES)，以帮助解决招募HA参与者参加临床试验的困难。然而，这个系列还没有被系统地评估它的效果，焦点小组发现它对于外行受众应用来说太复杂了。作为回应，发展了fotonovelas，但缺乏促进知识、态度和行为转变所需的内容。该项目将把CTES最好的方案组成部分改编成一个单一的 英语和西班牙语的语言和文化相一致的临床试验教育计划。这一调整后的计划将作为一项随机对照试验的中心，以评估该计划帮助提高HAS的科学素养并积极改变他们对参与干预组临床试验的态度的能力，然后评估该组中科学素养的提高和态度的改善是否调节了对参与研究邀请的后续反应。他们的反应将与控制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，还将比较干预和控制参与者对参与PI的临床试验大使计划(ACTP)邀请的反应(ACTP通过让大使帮助研究招募他们社区的其他成员来促进研究的参与)。基线数据收集还将包括经过验证的人口、健康、文化和心理社会工具，以允许研究人员确定参与者的个人特征是否对临床试验教育计划的反应适度。主要的研究目标是确定NCI的教育计划是否可以调整和应用，以开始在HA社区内创建与临床试验参与相关的知识、态度和行为的转变过程。如果这一教育计划是有效的，将会立即和长期地对公共卫生产生好处。该计划将有 在医管局社区内对参与研究性研究的知识和态度产生积极转变的直接效果。这将创造一批医管局社区成员，他们可以直接被邀请参与研究，并帮助打开社区通往研究社区的大门，从而使该地区的研究社区受益。最终，这将促进医管局社区的健康和福祉，因为更多地参与健康研究增加了研究结果对该社区的普适性。

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.