Communicating about Clinical Trials:Bringing the CIS to the Underserved

描述(由申请人提供)：背景：公立医院的患者往往具有较低的社会经济地位和不同的种族/民族(“服务不足”)，在了解和管理他们的疾病方面几乎没有选择，他们在临床试验中的代表性也很低。国家癌症研究所的癌症信息服务(CIS)是为公众提供高质量癌症信息的来源，但在很大程度上没有被最有需要的人使用。具体目标：为了提供适当的临床试验信息，以支持公立医院的患者做出明智的治疗决定，本研究有三个具体目标：1.评估和记录非裔美国人、拉丁裔和白人公立医院癌症患者的临床试验信息需求；2.通过修改现有的针对低识字率和多元文化的CIS电话应答并开发主动电话协议来评估和调整CIS关于临床试验信息的服务标准，以改进呼叫者提问技能、提高信息有效性和鼓励参与临床试验；以及3.对新修订的方案进行可行性和有效性的试点测试。研究设计：本研究分为两个阶段。在第一阶段，将使用多种定性方法来了解临床试验信息需求，并开发和预测增强的CIS方案。我们将深入了解患者归因于临床试验和研究的含义，记录患者用于讨论临床试验和实验治疗的语言，并通过直接观察和民族志访谈观察围绕提供者/患者临床试验信息共享的有效沟通和错误沟通。我们将通过：i)审查独联体标准临床试验培训；ii)促使患者致电独联体，然后进行患者和电话专家的汇报面谈；以及iii)患者焦点小组，调整/制定适合文化的方案。在第二阶段，我们将通过电话会议前和电话会议后的访谈，试行测试调整后的协议的可行性和有效性。概念框架来自主观文化、知情决策和社会学习理论。与公共卫生的相关性：少数群体更多地参与临床试验研究已被确定为解决癌症差异的一种手段。最近的研究表明，如果获得适当的信息和机会，少数族裔与非西班牙裔白人一样愿意参与临床研究。这项研究建立在现有的、联邦资助的癌症信息资源(CIS)的基础上，旨在将适当的癌症临床试验信息带给服务不足的癌症患者及其家人，他们最需要这些信息。

DESCRIPTION (provided by applicant): Background: Public hospital patients, often of low socioeconomic status and diverse race/ethnicity (the "underserved"), have few options for understanding and managing their illness, and they are also underrepresented in clinical trials. The National Cancer Institute's Cancer Information Service (CIS), a source of high quality cancer information for the public has gone largely unused by those most in need. Specific Aims: To provide appropriate clinical trials information to support public hospital patients making informed decisions about their treatment, this study has three specific aims: 1. to assess and document clinical trial information needs of African American, Latino, and White public hospital cancer patients; 2. to assess and adapt the CIS standard of service regarding clinical trial information through modification of current CIS telephone response for low literacy and diverse cultures and development of a proactive telephone protocol to improve caller question asking skills, increase information efficacy, and encourage participation in clinical trials; and 3. To pilot test the new adapted protocol for feasibility and efficacy. Study Design: This study consists of two phases. In Phase 1 multiple qualitative methods will be used to understand clinical trial information needs and to develop and pretest enhanced CIS protocols. We will gain insight into meanings patients attribute to clinical trials and 'research', document language patients use to discuss clinical trials and experimental treatments, and observe effective communications and miscommunications around provider/patient clinical trial information sharing through direct observations and ethnographic interviews. We will adapt/develop culturally appropriate protocols through: i) review of standard CIS clinical trials training; ii) prompted calls by patients to the CIS followed by patient and phone specialist debriefing interviews; and iii) patient focus groups. In Phase II we will pilot test the adapted protocols for feasibility and efficacy using pre- and post-call interviews. The conceptual framework is drawn from Subjective Culture, Informed Decision-making, and Social Learning Theories. Relevance to Public Health: Increasing participation of minorities in clinical trials research has been identified as a means to address cancer disparities. Recent research suggests that minorities are as willing as non-Hispanic whites to participate in clinical research if given appropriate information and opportunity. Building upon a pre-existing, federally funded cancer information resource (CIS), this study aims to bring appropriate cancer clinical trials information to underserved cancer patients and their families who need it the most.