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，通常社会经济地位低，种族/民族多样（“服务不足”），了解和管理他们的疾病的选择很少，他们在临床试验中的代表性也不足。美国国家癌症研究所的癌症信息服务（CIS）是一个为公众提供高质量癌症信息的来源，但大多数最需要的人都没有使用。具体目标：为了提供适当的临床试验资料，以支持公立医院的病人作出明智的决定，他们的治疗，这项研究有三个具体目标：1。评估和记录非裔美国人、拉丁美洲人和白色公立医院癌症患者的临床试验信息需求; 2.评估和调整CIS关于临床试验信息的服务标准，方法是修改当前CIS针对低识字率和不同文化的电话应答，并制定积极主动的电话协议，以提高来电者提问技能，提高信息效率，并鼓励参与临床试验;以及3.对新的适应性方案的可行性和有效性进行试点测试。研究设计：本研究分为两个阶段。在第1阶段，将使用多种定性方法来了解临床试验信息需求，并制定和预测试增强的CIS方案。我们将深入了解患者对临床试验和“研究”的意义，记录患者用于讨论临床试验和实验性治疗的语言，并通过直接观察和人种学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。我们将通过以下方式调整/制定文化上适当的方案：i）审查标准CIS临床试验培训; ii）促使患者致电CIS，然后进行患者和电话专家汇报访谈; iii）患者焦点小组。在第二阶段，我们将使用电话前和电话后访谈对适应性方案的可行性和有效性进行试点测试。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：少数群体越来越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，如果给予适当的信息和机会，少数民族和非西班牙裔白人一样愿意参与临床研究。基于一个预先存在的，联邦政府资助的癌症信息资源（CIS），这项研究的目的是把适当的癌症临床试验信息提供给最需要它的缺医少药的癌症患者及其家属。

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.