Understanding Tobacco Treatment Refusal Among African-Americans in the Context of Lung Cancer Screening

ChloéM.Martin博士试图通过以下方式更好地理解母体临床试验的影响范围 调查符合条件的非裔美国吸烟者中与参与拒绝相关的因素。马丁医生是 对这个项目感兴趣是因为在烟草行业招募非裔美国人是公认的 戒烟方案往往具有挑战性(伍兹等人，2002年)。非裔美国人患有高度肺癌 死亡率(Wood等人，2002；Holford，Levy，&Meza，2016；疾病控制和预防中心， 2018年)。吸烟对美国黑人和白人男性的预期寿命差距有很大影响。 (Ho&Elo，2013)，而且非常昂贵(Max Sung，Tucker，&Stark，2010)。另一方面，非洲裔美国人 吸烟者表示他们想戒烟(Kulak，Cornelius，Fong，&Giovino，2016；Weinberger，Esan， 亨特和霍夫，2016；)当提供循证烟草治疗时，非裔美国人 能够成功戒烟(Webb等人，2010；Burgess等人，2014)，导致肺减少 癌症死亡率(Tanner等人，2015；Holford，Levy，&Meza，2016；疾病控制和治疗中心 预防，2018年)。在烟草治疗试验中招募非裔美国人面临的挑战 已经被记录在案(伍兹等人，2002年)。了解为什么符合条件的非裔美国人吸烟者 拒绝参加烟草治疗试验的人决定不参加可以有助于减少 肺癌发病率和死亡率(Kilbourne，Switzer，Hyman，Crowley-Matoka，&Fine，2006)。 母公司的研究是检验与招募和参与非洲人相关的因素的理想选择- 美国吸烟者，因为这是一项多地点试验，已经解决了非洲人- 美国参与临床试验。例如，围绕招募少数族裔进行临床试验的挑战 被分为四大领域：与接入有关的问题、结构因素、提供商信念以及 社会文化因素(伍兹等人，2002年)。与准入有关的招聘挑战包括： 医疗保健水平低下，识字率低，目标人群对 研究和运输方面的挑战。父研究通过利用 接受包括医疗补助在内的各种保险方式的肺癌筛查网站。这个 作为招聘挑战的结构性因素包括：不适合支持的基础设施 研究、有限的参与者补偿、时间限制和有限的工作人员(伍兹等人，2002年)。这个 家长研究通过将研究的程序整合到当前的工作流程中来绕过结构性问题 放映地点。供应商信念带来的招聘挑战包括：缺乏 推荐参与，提供者不知道临床试验，以及提供者对学术不信任 医学(伍兹等人，2002年)。家长研究通过提供推荐来避免与提供者信念相关的问题 在作出肺癌筛查预约时参加试验。 母公司研究将受益于改进其招聘战略，以解决社会文化因素 这影响了临床试验中少数族裔的招募(Wood等人，2002年)。这些社会文化因素 包括：由于之前不道德地剥削非裔美国人的行为而对研究人员的不信任 研究和医疗行业(Roberson，1994；Corbie-Smith，Thomas，Williams，MoodyAyers，1994； Harris，Gorelick，Samuels，Bempong，1996)，沟通问题(Harris等人，1996)，朋友的意见 以及对自我效能感的态度和信念(Wood等人，2002年)。一些策略可以 以前的研究已经采用了绕过非裔美国人参与临床的社会文化障碍 试验包括使用由非裔美国人社区组成的社区咨询委员会 成员(Cox等人，2011)，向潜在参与者邮寄个性化邀请信(Spence& Oltmanns，2011)，确保知情同意文件的自主性，并分享 之前的参与者，并使用大众广告平台，涉及来自 非裔美国人社区(Okuyemi等人，2007年)。可持续、以经验为基础的招聘努力 消除非洲裔美国人参与戒烟试验的障碍是必要的。 具体目标 目标1：为了更好地了解非洲人拒绝参加烟草治疗试验的情况- 美国吸烟者使用严格的定性方法。 目标2：制定和评估旨在招募非洲裔美国人吸烟者的招募战略 烟草治疗试验。

Dr. Chloé M. Martin seeks to develop a better understanding of the reach of the parent clinical trial by examining factors associated with participation refusal among eligible African-American smokers. Dr. Martin is interested in pursuing this project because it is well established that recruiting African-Americans in tobacco cessation programs is often challenging (Woods et al., 2002). African-Americans have high lung cancer mortality (Woods et al., 2002; Holford, Levy, & Meza, 2016; Centers for Disease Control and Prevention, 2018). Smoking significantly contributes to the life expectancy gap between Black and White men in the U.S. (Ho & Elo, 2013) and is very costly (Max Sung, Tucker, & Stark, 2010). On the other hand, African-American smokers indicate that they want to quit smoking (Kulak, Cornelius, Fong, & Giovino, 2016; Weinberger, Esan, Hunt, & Hoff, 2016; ) and when provided with evidence-based tobacco treatment, African-Americans have been able to successfully quit smoking (Webb et al., 2010; Burgess et al., 2014) resulting in reduced lung cancer mortality (Tanner et al., 2015; Holford, Levy, & Meza, 2016; Centers for Disease Control and Prevention, 2018). The challenges associated with recruiting African-Americans in tobacco treatment trials have already been documented (Woods et al., 2002). Understanding why eligible African-American smokers who refuse participation in tobacco treatment trials decide not to participate can contribute to the reduction of lung cancer morbidity and mortality (Kilbourne, Switzer, Hyman, Crowley-Matoka, & Fine, 2006). The parent study is ideal for examining factors associated with recruitment and engagement of African- American smokers because it is a multi-site trial that already addresses some of the barriers to African- American participation in clinical trials. For example, challenges around minority recruitment for clinical trials have been categorized into four broad areas: issues related to access, structural factors, provider beliefs, and sociocultural factors (Woods et al., 2002). Recruitment challenges that have been related to access include: subpar healthcare, low literacy, the target population having a limited understanding of the purpose of research, and transportation challenges. The parent study addresses issues related to access by utilizing a diverse set of lung cancer screening sites who accept a variety of insurance modalities including Medicaid. The structural factors that have served as recruitment challenges include: unsuitable infrastructures to support research, limited participant reimbursements, time constraints, and limited staff (Woods et al., 2002). The parent study circumvents structural issues by integrating the study's procedures into the current workflow of the screening sites. The recruitment challenges that are born of provider beliefs have included: lack of referrals for participation, providers being unaware of clinical trials, and providers' distrust of academic medicine (Woods et al., 2002). The parent study avoids issues related to provider beliefs by providing referrals for participation in the trial at the time that the lung cancer screening appointment is made. The parent study would benefit from improving its recruitment strategy to address sociocultural factors that have impacted recruitment of minorities in clinical trials (Woods et al., 2002). These sociocultural factors have included: mistrust of researchers due to previous acts of unethical exploitation of African-Americans by the research and medical industries (Roberson, 1994; Corbie-Smith, Thomas, Williams, MoodyAyers, 1994; Harris, Gorelick, Samuels, Bempong, 1996), communication issues (Harris et al., 1996), opinions of friends and family members, and attitudes and beliefs around self-efficacy (Woods et al., 2002). Some strategies that previous studies have employed to circumvent sociocultural barriers to African-American participation in clinical trials have included the use of community advisory boards composed of African-American community members (Cox et al., 2011), mailing personalized invitation letters to prospective participants (Spence & Oltmanns, 2011), ensuring autonomy in the informed consent documents, and sharing success stories from previous participants, and using mass advertisement platforms that involve key influential leaders from the African-American community (Okuyemi et al., 2007). Sustainable, empirically-based recruitment efforts that address barriers to participation of African-Americans in tobacco cessation trials are needed. Specific Aims Aim 1: To gain a better understanding of participant refusal in a tobacco treatment trial among African- American smokers using a rigorous qualitative approach. Aim 2: To develop and evaluate a recruitment strategy designed to recruit African-American smokers in a tobacco treatment trial.