Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity.

Objective: The exclusion criteria of tobacco cessation randomized clinical trials (RCTs) may have unintended consequences on inclusion and cessation disparities. We examined racial/ethnic differences in: a) exclusion from a group-based cessation RCT; and b) reasons for exclusion. Design: Quasi-experimental. Inclusion criteria were self-identification as African American/Black, non-Hispanic White, or Hispanic (any race), adults, minimum five cigarettes/day or carbon monoxide reading of ≥ 8 parts per million (ppm), interest in quitting, and spoke/read English. Data were obtained from a parent trial, which is ongoing and will be completed in 2019. Analyses for our present study on participant screening and enrollment were conducted in 2018. Main Outcome Measures: Study ineligibility, and reasons for exclusion (contraindications for nicotine patch use, serious mental illness [SMI, eg, bipolar disorder or schizophrenia], alcohol dependence or illicit drug use, current tobacco treatment, attendance barriers [eg, transportation], and other concerns [eg, aggressive, intoxicated, disruptive, visibly ill]). Results: Of 1,206 individuals screened, 36% were ineligible. The most frequent reasons were SMI (28%), alcohol dependence or drug use (10%), and attendance barriers (7%). Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P<.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P<.05). Conclusions: A notable proportion of smokers were ineligible for this RCT, with SMI as the greatest single cause. Racial/ethnic minorities were more likely to be excluded, with African Americans deemed ineligible for multiple reasons. Findings have implications for RCT generalizability, addressing tobacco disparities and health equity.

Recruiting racially and ethnically diverse smokers seeking treatment: Lessons learned from a smoking cessation randomized clinical trial.

INTRODUCTION: Recruiting racial/ethnic minorities in smoking cessation trials is a priority. This study described lessons learned from recruiting a diverse sample of African American, White, and Hispanic/Latinx smokers in a smoking cessation trial. METHODS: We implemented a 42-month recruitment campaign utilizing reactive (e.g., word-of-mouth, newspaper, radio, online ads, flyers, community partnerships) and proactive (e.g., direct invitations) strategies. We included 821 participants in the analysis. We described our recruitment strategies' implementation, their enrollment yield and rate (number enrolled/number screened) by race/ethnicity, and direct cost-per-participant (CPP: total cost/number of enrolled) for paid strategies. RESULTS: Enrollment yields were higher using reactive strategies than proactive strategies (94.3% vs. 5.7%). The top source of enrollment was word-of-mouth among African Americans (36%) and Whites (44%), and flyers among Hispanics/Latinxs (34%). Proactive recruitment, word-of-mouth, and flyers were more successful among African Americans than other groups. Newspaper and online ads were more successful among Hispanics/Latinxs than other groups (P < .05). Word-of-mouth was cost-free and yielded 23.1% of enrollment. The most economic method among paid strategies was flyer distribution (CPP = $47.6; yield 17.5%), followed by newspaper ($194.7; 23.7%) and online advertisements ($264.6; 24.0%). Radio and television ads were the most expensive and produced the least participant yield ($4,755.6; 0.8%). CONCLUSION: Recruiting racially/ethnically diverse samples into smoking cessation clinical trials requires implementing multiple strategies and adjusting these strategies based on their enrollment yield and cost. Word-of-mouth, flyers, and newspaper and online ads were more successful among racial/ethnic minorities. Flyers and newspaper ads were the most economic methods for recruitment.

Reach versus effectiveness: The design and protocol of randomized clinical trial testing a smartphone application versus in-person mindfulness-based smoking cessation intervention among young cancer survivors.

Approximately 45% of young cancer survivors (18-40 years) are cigarette smokers. Continued smoking after cancer diagnosis leads to lower survival rates. A major logistical problem with smoking cessation efforts in this group is their geographic dispersion which makes them hard to reach. In addition, depression is a major predictor of smoking relapse and its rates are roughly twice as high in cancer survivors as the general population. Smartphone applications (apps) show promise in terms of efficacy, dissemination, and improving access to treatment. Mindfulness training (defined as maintaining attention on one's immediate experience and cultivating an attitude of acceptance toward this experience) is effective in improving smoking cessation outcomes by reducing psychological stress and controlling craving. Given that smartphone apps can address the issues of mobility and remote access, and mindfulness can address the high depression rate among cancer survivors, validating the feasibility and efficacy of a mindfulness-based smoking cessation intervention app in young cancer survivors is a high priority. Thus, the aims of the current study are: (1) test the feasibility, acceptability, and potential efficacy of the mindfulness-based smoking cessation app versus in-person mindfulness or usual care in a 3-arm pilot randomized clinical trial among young cancer survivors (n = 60; 18-40 years); and 2) conduct semi-structured exit interviews with participants in the two mindfulness groups to fine-tune the two active interventions based on feedback from participants. Findings will have implications for the development and dissemination of innovative and highly scalable tobacco cessation interventions designed for young cancer survivors.