Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial.

BACKGROUND: Hispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish-language, extended self-help smoking cessation intervention among Hispanic smokers. METHODS: A 2-arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish-language self-help booklet from the National Cancer Institute. The primary outcome was self-reported 7-day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost-effectiveness was also evaluated. All statistical tests were 2-sided. RESULTS: Data from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P < .001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18-2.02; P = .002). Men exhibited a strong intervention effect at all assessments (P values < .001), whereas the intervention effect for women was observed only at 6 and 12 months (P values < .018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months. CONCLUSIONS: A culturally relevant, Spanish-language intervention was efficacious and cost-effective for smoking cessation. LAY SUMMARY: Research is needed to develop interventions for ethnic minority smokers. The aim of the current study was to test a Spanish-language adaptation of a validated and easily implemented self-help smoking cessation intervention in a nationwide randomized controlled trial. The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self-help booklet. Participants also were more satisfied with the intervention, and it was cost-effective. Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking.

Preventing smoking relapse in patients with cancer: A randomized controlled trial.

BACKGROUND: Abstaining from smoking after a cancer diagnosis is critical to mitigating the risk of multiple adverse health outcomes. Although many patients with cancer attempt to quit smoking, the majority relapse. The current randomized controlled trial evaluated the efficacy of adapting an evidence-based smoking relapse prevention (SRP) intervention for patients with cancer. METHODS: The trial enrolled 412 patients newly diagnosed with cancer who had recently quit smoking. Participants were randomized to usual care (UC) or SRP. Participants in the UC group received the institution's standard of care for treating tobacco use. Participants in the SRP group in addition received a targeted educational DVD plus a validated self-help intervention for preventing smoking relapse. The primary outcome was smoking abstinence at 2 months, 6 months, and 12 months. RESULTS: Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20). At 12 months, abstinence rates among survivors were 68% for those in the SRP group and 63% for those in the UC group (P = .38). Post hoc analyses revealed that across 2 months and 6 months, patients who were married/partnered were more likely to be abstinent after SRP than UC (P = .03). CONCLUSIONS: A smoking relapse prevention intervention did not reduce relapse rates overall, but did appear to have benefited those participants who had the social support of a partner. Future work is needed to extend this effect to the larger population of patients.

How Does Smoking and Nicotine Dependence Change After Onset of Vaping? A Retrospective Analysis of Dual Users.

INTRODUCTION: Although some smokers switch to exclusive use of electronic cigarettes (e-cigarettes), others become dual users of combustible cigarettes and e-cigarettes. Little is known about how the onset of vaping affects the use of and dependence on combustible cigarettes or total nicotine use and dependence, which may influence health-related and cessation outcomes. Using self-report data of current combustible and e-cigarette use and retrospective recall of pre-vaping smoking in a sample of dual users, the aims of this study were (1) to compare pre- and post-vaping number of cigarettes per day and combustible cigarette dependence; (2) to compare pre- and post-vaping total nicotine use frequency (number of vaping sessions and cigarettes smoked per day), and total nicotine dependence; and (3) to examine predictors of nicotine dependence. METHODS: We used baseline data from a smoking cessation trial with 2896 dual users. Nicotine use frequency and the Heaviness of Smoking Index were used as measures of nicotine use and dependence, respectively. RESULTS: Participants decreased cigarettes/day from pre- (M = 19.24, SD = 9.01) to post-vaping (M = 11.15, SD = 8.02, p < .0001) and combustible cigarette dependence declined from pre- (M = 3.55, SD = 1.51) to post-vaping (M = 2.11, SD = 1.60, p < .0001). Total daily nicotine use frequency increased after initiating vaping (M = 19.25, SD = 9.01 vs. M = 29.46, SD = 8.61; p < .0001), as did total nicotine dependence (M = 3.55, SD = 1.51 vs. M = 4.68, SD = 1.38; p < .0001). Hierarchical regression analyses indicated that variables associated with greater overall nicotine dependence included: younger age, lower education, more years smoking, higher pre-vaping nicotine dependence, using e-cigarettes more days per month, more puffs per vaping session, higher e-liquid nicotine concentration, and longer vaping history. CONCLUSIONS: Dual use leads to a reduction in the number of combustible cigarettes, but total nicotine use and dependence increases. IMPLICATIONS: In dual users, a reduction in smoking following onset of vaping may offer some harm reduction via reduction in cigarette intake. However, the increase in total nicotine use and dependence could affect the ability to quit either or both products.

Comparing Methods of Recruiting Spanish-Preferring Smokers in the United States: Findings from a Randomized Controlled Trial.

BACKGROUND: There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials. OBJECTIVE: Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost. METHODS: Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307). RESULTS: Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001). In addition, a greater percentage of individuals were employed (P<.001) and foreign born (P=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (P<.001) and a greater percentage of individuals were of Central American (P=.02), South American (P=.01), and Cuban (P<.001) origin. CONCLUSIONS: Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers.

Electronic cigarette use among patients with cancer: Reasons for use, beliefs, and patient-provider communication.

OBJECTIVE: Smoking tobacco cigarettes after a cancer diagnosis increases risk for several serious adverse outcomes. Thus, patients can significantly benefit from quitting smoking. Electronic cigarettes are an increasingly popular cessation method. Providers routinely ask about combustible cigarette use, yet little is known about use and communication surrounding e-cigarettes among patients with cancer. This study aims to describe patterns, beliefs, and communication with oncology providers about e-cigarette use of patients with cancer. METHODS: Patients with cancer (N = 121) who currently used e-cigarettes were surveyed in a cross-sectional study about their patterns and reasons for use, beliefs, and perceptions of risk for e-cigarettes, combustible cigarettes, and nicotine replacement therapies. Patient perspectives on provider communication regarding e-cigarettes were also assessed. RESULTS: Most participants identified smoking cessation as the reason for initiating (81%) and continuing (60%) e-cigarette use. However, 51% of patients reported current dual use of combustible cigarettes and e-cigarettes, and most patients reported never having discussed their use of e-cigarettes with their oncology provider (72%). Patients characterized e-cigarettes as less addictive, less expensive, less stigmatizing, and less likely to impact cancer treatment than combustible cigarettes (Ps < .05), and more satisfying, more useful for quitting smoking, and more effective at reducing cancer-related stress than nicotine replacement therapies (Ps < .05). CONCLUSIONS: Patients with cancer who use e-cigarettes have positive attitudes toward these devices and use them to aid in smoking cessation. This study also highlights the need for improved patient-provider communication on the safety and efficacy of e-cigarettes for smoking cessation.

Facilitated Extinction Training to Improve Pharmacotherapy for Smoking Cessation: A Pilot Feasibility Trial.

Introduction: Varenicline reduces smoking satisfaction during the pre-cessation run-in period, which may contribute to extinction of cravings and smoking behavior. Research indicates that efficacy is enhanced when the run-in period is increased from 1 to 4 weeks, providing a longer extinction opportunity. We hypothesized that efficacy could be further enhanced by harnessing basic and applied research on extinction. We developed a pre-cessation extinction-facilitating intervention and tested its feasibility in a pilot trial. Methods: The facilitated extinction (FE) intervention comprised brief counseling and workbook-recommending strategies to maximize extinction processes during the run-in, including instructions to smoke at a normal rate across contexts and cues, and use of an extinction cue to enhance generalization. Participants were randomly assigned to one of three varenicline interventions: standard (1-week run-in), extended (4-week run-in), and extended + FE. Interventions were delivered prior to the target quit date (TQD). Assessments were conducted in weeks 1 and 4 pre-TQD and 1 and 3 months post-TQD, with focus on feasibility indices. Results: Recruitment and retention goals were met (N = 58). Treatment satisfaction was high across groups. The majority of FE participants adhered to instructions and maintained their usual smoking rate during the run-in period. Greater decreases in craving and smoking satisfaction were observed among participants in both extended groups versus the standard group (p < .005). Conclusions: Feasibility was demonstrated. Participants adhered to the FE intervention, thereby optimizing the number and variety of extinction trials. Findings support testing the novel FE smoking cessation intervention in a fully powered trial. Implications: This study expands the research on the clinical benefits of extending the pre-cessation run-in period of varenicline. It introduces the hypothesis that further benefit might be achieved by translating basic behavioral research, as well as cue-exposure research and therapy for other disorders, to improve the extinction and generalization processes thought to underlie much of varenicline's effect. A FE intervention was developed and found acceptable to smokers and feasible to implement in a research setting. The study sets the stage for a subsequent randomized controlled trial.

Systematic Transcreation of Self-Help Smoking Cessation Materials for Hispanic/Latino Smokers: Improving Cultural Relevance and Acceptability.

Smoking-related illnesses are the leading causes of death among Hispanics/Latinos. Yet, there are few smoking cessation interventions targeted for this population. The goal of this study was to "transcreate" an existing, previously validated, English language self-help smoking cessation intervention, titled Forever Free®: Stop Smoking for Good, for Spanish-speaking smokers. Rather than simply translating the materials, our transcreation process involved culturally adapting the intervention to enhance acceptability and receptivity of the information. We utilized a multiphase qualitative approach (focus groups and learner verification interviews) to develop a linguistically and culturally relevant intervention for the diverse sub-ethnic groups of Hispanic/Latino smokers. Focus group findings indicated a need to underscore several additional cultural characteristics and themes such as the need to address familism and unique stressors faced by immigrants and to provide information regarding nicotine replacement therapy. Learner verification findings indicated a need to further emphasize financial and social benefits of quitting smoking and to discuss how family and friends can support the quit attempt. These steps led to the development of a Spanish-language smoking cessation intervention titled, Libre del cigarillo, por mi familia y por mí: Guía para dejar de fumar, that is currently being tested in a national randomized controlled trial.

Development of a Targeted Smoking Relapse-Prevention Intervention for Cancer Patients.

We describe the series of iterative steps used to develop a smoking relapse-prevention intervention customized to the needs of cancer patients. Informed by relevant literature and a series of preliminary studies, an educational tool (DVD) was developed to target the unique smoking relapse risk factors among cancer patients. Learner verification interviews were conducted with 10 cancer patients who recently quit smoking to elicit feedback and inform the development of the DVD. The DVD was then refined using iterative processes and feedback from the learner verification interviews. Major changes focused on visual appeal, and the inclusion of additional testimonials and graphics to increase comprehension of key points and further emphasize the message that the patient is in control of their ability to maintain their smoking abstinence. Together, these steps resulted in the creation of a DVD titled Surviving Smokefree®, which represents the first smoking relapse-prevention intervention for cancer patients. If found effective, the Surviving Smokefree® DVD is an easily disseminable and low-cost portable intervention which can assist cancer patients in maintaining smoking abstinence.

Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline: A Randomized Controlled Effectiveness Trial.

INTRODUCTION: Relapse prevention (RP) remains a major challenge to smoking cessation. Previous research found that a set of self-help RP booklets significantly reduced smoking relapse. This study tested the effectiveness of RP booklets when added to the existing services of a telephone quitline. METHODS: Quitline callers (N = 3458) were enrolled after their 2-week quitline follow-up call and randomized to one of three interventions: (1) Usual Care: standard intervention provided by the quitline, including brief counseling and nicotine replacement therapy; (2) Repeated Mailings (RM): eight Forever Free RP booklets sent to participants over 12 months; and (3) Massed Mailings: all eight Forever Free RP booklets sent upon enrollment. Follow-ups were conducted at 6-month intervals, through 24 months. The primary outcome measure was 7-day-point-prevalence-abstinence. RESULTS: Overall abstinence rates were 61.0% at baseline, and 41.9%, 42.7%, 44.0%, and 45.9% at the 6-, 12-, 18- and 24-month follow-ups, respectively. Although RM produced higher abstinence rates, the differences did not reach significance for the full sample. Post-hoc analyses of at-risk subgroups revealed that among participants with high nicotine dependence (n = 1593), the addition of RM materials increased the abstinence rate at 12 months (42.2% vs. 35.2%; OR = 1.38; 95% CI = 1.03% to 1.85%; P = .031) and 24 months (45% vs. 38.8%; OR = 1.31; 95% CI = 1.01% to 1.73%; P = .046). CONCLUSIONS: Sending self-help RP materials to all quitline callers appears to provide little benefit to deterring relapse. However, selectively sending RP booklets to callers explicitly seeking assistance for RP and those identified as highly dependent on nicotine might still prove to be worthwhile.

E-cigarette use in adults: a qualitative study of users' perceptions and future use intentions.

BACKGROUND: There has been an exponential increase in the prevalence of e-cigarette use, particularly among youth. However, adult use is also rising, and there have been relatively few qualitative studies with adult users to understand their reasons for use and future use intentions. Such information is needed to inform both prevention and cessation approaches. METHOD: Thirty-one e-cigarette users participated in one of several focus groups assessing the appeal of e-cigarettes as well as comparisons to combustible cigarettes and approved smoking cessation aids. We also obtained perspectives on future use intentions and interest in e-cigarette cessation interventions. Verbatim transcripts were analyzed using the constant comparative method. RESULTS: Participants reported several aspects of e-cigarette appeal as compared to approved cessation treatment options. These included similarities to combustible cigarettes, fewer side effects, and control of e-cigarettes to suit personal preferences. Participants were split on whether they preferred flavors that mimicked or contrasted with their combustible cigarettes (i.e., tobacco vs. alternative flavors, such as candy). Some participants who were unmotivated to quit smoking reported an unanticipated disinterest in continuing use of combustible cigarettes shortly after initiating e-cigarettes. Despite strong interest in reducing nicotine dosage, the majority did not intend to fully discontinue e-cigarettes. CONCLUSIONS: Understanding e-cigarette users' perspectives can inform policy and treatment development. Regulatory and policy initiatives will need to balance the appealing characteristics of e-cigarettes with the potential for negative public health outcomes.

Expectancies for cigarettes, e-cigarettes, and nicotine replacement therapies among e-cigarette users (aka vapers).

INTRODUCTION: Use of e-cigarettes has been increasing exponentially, with the primary motivation reported as smoking cessation. To understand why smokers choose e-cigarettes as an alternative to cigarettes, as well as to US Food and Drug Administration (FDA)--approved nicotine replacement therapies (NRT), we compared outcome expectancies (beliefs about the results of drug use) for the three nicotine delivery systems among vapers, i.e., e-cigarette users, who were former smokers. METHODS: Vapers (N = 1,434) completed an online survey assessing 14 expectancy domains as well as perceived cost and convenience. We focused on comparisons between e-cigarettes and cigarettes to determine the attraction of e-cigarettes as a smoking alternative and between e-cigarettes and NRT to determine perceived advantages of e-cigarettes over FDA-approved pharmacotherapy. RESULTS: Participants believed that e-cigarettes, in comparison to conventional cigarettes, had fewer health risks; caused less craving, withdrawal, addiction, and negative physical feelings; tasted better; and were more satisfying. In contrast, conventional cigarettes were perceived as better than e-cigarettes for reducing negative affect, controlling weight, providing stimulation, and reducing stress. E-cigarettes, compared to NRT, were perceived to be less risky, cost less, cause fewer negative physical feelings, taste better, provide more satisfaction, and be better at reducing craving, negative affect, and stress. Moderator analyses indicated history with ad libitum forms of NRT was associated with less positive NRT expectancies. CONCLUSIONS: The degree to which expectancies for e-cigarettes differed from expectancies for either tobacco cigarettes or NRT offers insight into the motivation of e-cigarette users and provides guidance for public health and clinical interventions to encourage smoking-related behavior change.

A content analysis of attributions for resuming smoking or maintaining abstinence in the post-partum period.

A significant proportion of women who self-quit smoking during pregnancy subsequently relapse to smoking post-partum. This study examined free-text responses describing attributions of smoking relapse or maintained abstinence at 1, 8, and 12 months post-partum. This study reports secondary analyses from a randomized clinical trial (N = 504) for preventing post-partum smoking relapse. At each follow-up, one survey item asked the participant to describe why she resumed smoking or what helped her maintain abstinence. A thematic content analysis was conducted on responses from the 472 participants (94.0 % of the original sample) who returned at least 1 survey. Content analyses revealed several themes for participants' reasons for relapse and abstinence. Stress was the most frequently cited reason for smoking relapse across all follow-ups. Health concerns for children and family was the most common reason provided for remaining abstinent. Chi square analyses revealed differences in written responses related to income, age, and depressive symptoms. Overall, these findings suggest that during the post-partum period, stress and familial health concerns are perceived contributors to smoking relapse and abstinence, respectively. These results confirmed key risk and protective factors that have been identified through other assessment modalities (e.g., quantitative surveys and focus groups). They also provide support for targeting these variables in the development, content, and delivery of future post-partum smoking relapse-prevention interventions. The high response rate to these open-ended attribution questions suggests that future studies would benefit from including these and similar items to allow for additional insight into participant perspectives.

Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial.

BACKGROUND: Although many smokers use electronic cigarettes (e-cigarettes) to quit smoking, most continue to smoke while vaping. This dual use might delay cessation and increase toxicant exposure. We aimed to test the efficacy of a self-help intervention designed to help dual users to quit smoking. METHODS: In this three-arm randomised controlled trial we recruited individuals in the USA using Facebook and multimedia advertisements. Included participants were 18 years or older, smoked at least weekly in the preceding year, and vaped at least weekly in the preceding month. We used computer generated randomisation with balanced-permuted blocks (block size 10, with 2-4-4 ratio) to allocate participants to assessment only (ASSESS group), generic smoking cessation self-help booklets (GENERIC group), or booklets targeting dual users (eTARGET group). Individuals in the generic or targeted intervention groups received monthly cessation materials for 18 months, with assessments every 3 months for 24 months. The main outcome was self-reported 7-day point-prevalence smoking abstinence at each assessment point. All randomly allocated participants were included in primary analyses using generalised estimating equations for each of 20 datasets created by multiple imputation. Analysis of the χ2s produced an F test. The trial is registered with ClinicalTrials.gov, NCT02416011, and is now closed. FINDINGS: Between July 12, 2016, and June 30, 2017, we randomly assigned 2896 dual users (575 to assessment, 1154 to generic intervention, and 1167 to targeted self-help). 7-day point-prevalence smoking abstinence increased from 14% at 3 months to 42% at 24 months (F7,541·7=67·1, p<0·0001) in the overall sample. Targeted self-help resulted in higher smoking abstinence than did assessment alone throughout the treatment period (F1,973·8=10·20, p=0·0014 [α=0·017]). The generic intervention group had abstinence rates between those of the assessment and targeted groups, but did not significantly differ from either when adjusted for multiple comparisons (GENERIC vs eTARGET F1,1102·5=1·79, p=0·18 [α=0·05]; GENERIC vs ASSESS F1,676·7=4·29, p=0·039 [α=0·025]). Differences between study groups attenuated after the interventions ended. INTERPRETATION: A targeted self-help intervention with high potential for dissemination could be efficacious in promoting smoking cessation among dual users of combustible cigarettes and e-cigarettes. FUNDING: National Institute on Drug Abuse, National Cancer Institute.

Development of a Self-Help Smoking Cessation Intervention for Dual Users of Tobacco Cigarettes and E-Cigarettes.

Most users of electronic cigarettes (e-cigarettes) report initiating use to quit combustible cigarettes. Nevertheless, high levels of dual use (i.e., using both combustible cigarettes and e-cigarettes) occur among adults. Using formative data from in-depth interviews and employing learner verification, we adapted an existing, validated self-help smoking-cessation intervention (Stop Smoking for Good; SSFG) to create a targeted intervention for dual users, If You Vape: A Guide to Quitting Smoking (IYV). In Phase I, in-depth interviews (n = 28) were conducted to assess relevance of the existing SSFG materials (10 booklets, nine pamphlets) and identify new content for the booklets. Next, for Phase II, learner verification interviews (n = 20 dual users) were conducted to assess their appeal and acceptability. Several key themes emerged from the Phase I in-depth interviews. Findings led to the inclusion of e-cigarette-specific strategies used by successful quitters such as gradually reducing nicotine levels, switching from tobacco flavor to alternative flavors, and limiting e-cigarette use to places one would normally smoke (i.e., not expanding use). Suggestions from Phase II learner verification included broadening the visual appeal for a younger, more diverse demographic, expanding tips for quitting smoking via e-cigarettes, and expanding terminology for e-cigarette devices. Beginning with an efficacious self-help intervention, we used a systematic process to develop a version specifically for dual users.

Capitalizing on a teachable moment: Development of a targeted self-help smoking cessation intervention for patients receiving lung cancer screening.

OBJECTIVE: The goal of the current study was to develop and examine the feasibility and acceptability of a self-help smoking cessation intervention targeted to the teachable moment of smokers undergoing low-dose computed tomography (LDCT) lung cancer screening. MATERIALS AND METHODS: We used a multi-phase qualitative approach, including focus groups (N = 15) and learner verification interviews (N = 16) to develop a targeted intervention for patients receiving a LDCT screening, by extending and modifying a previously validated, self-help intervention. The new intervention was then tested in a feasibility study for acceptability and receptivity by smokers (N = 18) receiving a LDCT screening. RESULTS: The main themes that emerged from the focus group findings included a need to address the counterproductive thoughts regarding a negative lung screen result, the desire to enjoy a healthy and smoke-free retirement, the need to increase self-efficacy regarding smoking cessation, and the desire to see statistics regarding survival after quitting smoking. Learner verification findings showed that participants responded favorably to most booklet and pamphlet changes. Minor changes were made to improve comprehension and enhance self-efficacy. Formative findings led to the development of a new initial booklet titled, "Lung Cancer Screening & Quitting Smoking: Taking Control of Your Health," as well as modifications of the existing self-help cessation intervention. The intervention was designed to be initiated at the LDCT appointment, prior to receipt of scan results, and with minimal disruption of clinic work-flow. Results from the feasibility study indicated that acceptability and satisfaction with the new intervention were high. CONCLUSION: A validated self-help smoking-cessation intervention was modified for smokers receiving LDCT screening for lung cancer based on formative research guided by the teachable moment concept. The new intervention is ready for testing in a randomized controlled trial.

A randomized controlled trial of a smoking cessation self-help intervention for Spanish-speaking Hispanic/Latinx smokers: Study design and baseline characteristics.

Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.

Vaping characteristics and expectancies are associated with smoking cessation propensity among dual users of combustible and electronic cigarettes.

BACKGROUND AND AIMS: Most e-cigarette users who also smoke combustible cigarettes (dual users) begin vaping to quit smoking, yet only a subset succeeds. We hypothesized that reinforcing characteristics of e-cigarettes (vaping reinforcement) would positively predict smoking cessation propensity (SCP) among dual users. DESIGN: Secondary analysis of cross-sectional baseline data from dual users in an ongoing smoking cessation trial. Exploratory and confirmatory factor analysis (EFA and CFA) created latent variables for vaping reinforcement and SCP. A structural equation modeling (SEM) approach was used to test the hypothesis. SETTING: United States. PARTICIPANTS: A national sample of dual users of combustible and electronic cigarettes who smoke and vape at least once per week (n = 2896) were enrolled (63% male; mean age = 29.9 years) into a randomized controlled trial in which they would receive either smoking cessation materials or no smoking cessation materials. MEASUREMENTS: Vaping reinforcement was indexed by vaping frequency (days/week vaping, times/day vaping, puffs/e-cigarette use), e-cigarette characteristics [numbers of modifications and tobacco or non-tobacco flavors, nicotine content (mg) and positive e-cigarette expectancies]. SCP was measured by items of confidence, commitment to being smoke-free, cessation motivation (contemplation ladder), change in cigarettes per day since beginning e-cigarette use and negative smoking expectancies. FINDINGS: Four factors emerged from the EFA: vaping propensity (vaping frequency, positive expectancies), vaping enthusiasm (e-cigarette modifications, using non-tobacco flavors, puffs per use), nicotine/tobacco flavor (nicotine strength, tobacco flavors) and SCP (negative expectancies about smoking, motivation to quit smoking, reduction in smoking). A CFA upheld the exploratory factor structure [root mean square error of approximation (RMSEA) = 0.046, CFI = 0.91]. An SEM with the three vaping latent variables directly predicting SCP had good model fit (RMSEA = 0.030, CFI = 0.97) with a positive relationship of vaping propensity (0.509, P < 0.001), and small negative relationships of vaping enthusiasm (-0.158, P = 0.014) and nicotine/tobacco flavor (-0.230, P < 0.001). CONCLUSIONS: Among e-cigarette users who also smoke combustible cigarettes, frequent vaping combined with positive e-cigarette expectancies appears to predict greater smoking cessation propensity. However, vaping enthusiasm (measured by e-cigarette modifications, using non-tobacco flavors and puffs per use), higher nicotine content and use of tobacco flavored solution may reduce cessation propensity.

Long-term outcomes from a self-help smoking cessation randomized controlled trial.

There is a need for effective smoking cessation interventions that can be disseminated easily in health care and other settings. We previously reported that an extended self-help intervention comprising intensive repeated mailings over 18 months improved abstinence rates through 6 months beyond the end of the intervention when compared to both a reduced version of the self-help materials and a traditional self-help booklet. This report extends the follow-up for an additional 6 months (30-months postbaseline) to examine long-term maintenance of the intervention effect. We hypothesized that the previously observed "dose-response" effect of treatment intensity would be maintained. Participants were randomized to Traditional Self-Help (TSH, n = 638), Standard Repeated Mailings (SRM, n = 614), or Intensive Repeated Mailings (IRM, n = 622). TSH received an existing self-help smoking cessation booklet. SRM received 8 cessation booklets mailed over 12 months. IRM received monthly mailings of 10 booklets and additional material to enhance social support over 18 months. Follow-up assessments occurred every 6 months through 30 months. Data were collected 2010-2013 and analyzed 2014-2017. At 1 year posttreatment, there was a linear dose effect with the highest abstinence rates observed in IRM (33%), followed by SRM (29%), and then TSH (23%; p = .002). Paired comparisons indicated that IRM was superior to TSH (p = .002). Results revealed a robust intervention effect for the intensive self-help intervention that was maintained 12 months after treatment completion. This further supports extended self-help as a low-cost intervention for smoking cessation. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated.