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，通常是低社会经济地位和不同种族/民族（“服务不足”），很少有选择来了解和管理他们的疾病，他们在临床试验中的代表性也不足。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，但在很大程度上却被那些最需要的人所利用。具体目的：为了提供适当的临床试验信息，以支持公立医院患者对其治疗做出明智的决定，本研究有三个具体目的：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. 评估和调整CIS关于临床试验信息的服务标准，方法是修改目前针对低文化水平和不同文化的CIS电话应答，并制定主动电话协议，以提高呼叫者的提问技巧，提高信息有效性，并鼓励参与临床试验；和3。对新的改编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，并开发和预测试增强的CIS协议。我们将深入了解患者赋予临床试验和“研究”的含义，记录患者用于讨论临床试验和实验性治疗的语言，并通过直接观察和人种学访谈观察提供者/患者临床试验信息共享方面的有效沟通和误解。我们将通过以下方式调整/制定符合文化的方案：i)审查标准的CIS临床试验培训；ii)促使病人致电本处，然后与病人及电话专家进行汇报；iii)患者焦点小组。在第二阶段，我们将通过电话前和电话后访谈对改编后的协议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：增加少数群体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，少数族裔和非西班牙裔白人一样愿意参与临床研究。本研究建立在一个预先存在的、由联邦政府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最需要的缺乏服务的癌症患者及其家人。

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.