Dr. Chlo 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.

Public Health Relevance

The goal of this study is to gain a better understanding of participant refusal in a tobacco treatment trial among African-American smokers using a rigorous qualitative approach and to develop and evaluate a recruitment strategy designed to recruit African-American smokers in a tobacco treatment trial.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Willis, Gordon B
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Sloan-Kettering Institute for Cancer Research
New York
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Joseph, Anne M; Rothman, Alexander J; Almirall, Daniel et al. (2018) Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration. Am J Respir Crit Care Med 197:172-182