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Introduction: Unlike other U.S. geographical regions, cigarette smoking prevalence remains stagnant in rural Appalachia. One avenue for reaching rural residents with evidence-based smoking cessation treatments could be utilizing community pharmacists. This paper describes the design, rationale, and analysis plan for a mixed-method study that will determine combinations of cessation treatment components that can be integrated within community pharmacies in rural Appalachia. The aim is to quantify the individual and synergistic effects of five highly disseminable and sustainable cessation components in a factorial experiment., Methods: This sequential, mixed-method research design, based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, will use a randomized controlled trial with a 2 5 fully crossed factorial design (32 treatment combinations) to test, alone and in combination, the most effective evidence-based cessation components: (1) QuitAid (yes vs. no) (2) tobacco quit line (yes vs. no) (3) SmokefreeTXT (yes vs. no) (4) combination NRT lozenge + NRT patch (vs. NRT patch alone), and (5) eight weeks of NRT (vs. standard four weeks)., Results: Logistic regression will model abstinence at six-months, including indicators for the five treatment factors and all two-way interactions between the treatment factors. Demographic and smoking history variables will be considered to assess potential effect modification. Poisson regression will model quit attempts and percent of adherence to treatment components as secondary outcomes., Conclusion: This study will provide foundational evidence on how community pharmacies in medically underserved, rural regions can be leveraged to increase utilization of existing evidence-based tobacco cessation resources for treating tobacco dependence., Clinical Trials: NCT05660525., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Tobacco and cannabis co-use is a growing public health problem. The synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared environmental cues reinforcing use may make tobacco smoking cessation more difficult. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use. NAC's potential efficacy in treating addiction may be attributable to its central nervous system effects in reducing excessive glutamatergic activity, oxidative stress, and inflammation. To date, no RCT has examined NAC for smoking cessation among dual users of tobacco and cannabis., Method: In a double-blind, placebo-controlled RCT, we will examine NAC for smoking cessation among dual users of tobacco and cannabis. Sixty adult cigarette-cannabis co-users are randomized to receive NAC 3600 mg per day or placebo over 8 weeks. Participants in both groups receive 8 weekly cognitive behavioral therapy sessions addressing smoking cessation and cannabis reduction. Outcomes are assessed at Weeks 0, 4, 8, and 12. Primary aims are to determine NAC's efficacy in decreasing cigarette craving, nicotine dependence, and use; and cannabis craving and use. Exploratory aims include examination of changes in neurocognition with NAC and their potential mediational effects on cigarette and cannabis use outcomes., Conclusion: Results will inform smoking cessation treatment among dual users of tobacco and cannabis., Clinicaltrials: gov Identifier: NCT04627922., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. None of the authors have any conflicts of interest to disclose. No authors declared competing interests associated with this publication., (Published by Elsevier Inc.)

Cigarette smoking is highly prevalent among cancer patients in the United States (US), with up to half of cancer patients smoking at the time of their initial cancer diagnosis. However, evidence-based cessation programs are rarely implemented in oncology care, and smoking is not consistently treated in cancer treatment settings. Consequently, there is an urgent need for accessible and efficacious cessation treatments that are uniquely tailored to the needs of cancer patients. Here we describe the design and implementation of a randomized controlled trial (RCT) testing the efficacy of a smartphone app (Quit2Heal) versus a US Clinical Practice Guidelines-based app (QuitGuide) for smoking cessation among a planned sample of 422 cancer patients. Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting. Quit2Heal is based on the principles of Acceptance and Commitment Therapy, a behavioral therapy that teaches skills for accepting cravings to smoke without smoking, values-driven motivation to quit, and preventing relapse. The primary aim of the RCT is to determine whether Quit2Heal has significantly higher self-reported 30-day point prevalence abstinence at 12 months relative to QuitGuide. The trial will also determine whether Quit2Heal's effect on cessation is (1) mediated by improvements in cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting; and (2) moderated by baseline factors (e.g., cancer type, stage, time since diagnosis). If successful, Quit2Heal will offer a more efficacious, broadly scalable smoking cessation treatment that could be implemented alongside existing oncology care, thereby improving cancer outcomes., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Electronic cigarette (ECIG) use has become a popular method for nicotine delivery. Combustible cigarette (CC) cessation or reduction are the primary reasons for ECIG uptake among adults. Yet, most CC smokers who initiate ECIG use do not fully transition from CC to ECIG, despite intending to quit CC completely. Retraining approach bias, or the approach action tendency toward stimuli related to the substance of interest, has been effective in alcohol and CC use treatments. However, approach bias retraining for both CC and (ECIG) users has not been explored. Therefore, the objective of the study is to evaluate the initial efficacy of approach bias retraining among dual CC and ECIG users., Methods: Eligible dual CC/ECIG using adults (N = 90) will complete a phone-screener, baseline assessment, 4 treatment sessions over 2 weeks, ecological momentary assessments (EMAs) post-intervention, and follow-ups at 4- and 6-week post-intervention. Participants will be assigned to one of three conditions at baseline: (1) CC + ECIG retraining; (2) CC only retraining; and (3) sham retraining. Participants will engage in a self-guided quit attempt to abstain from all nicotine products starting at treatment session 4., Conclusions: The study may lead to a more effective treatment for at-risk nicotine users while simultaneously isolating explanatory mechanisms. The findings should guide advances in the theoretical conceptualization of nicotine addiction for dual users and mechanisms involved in maintaining and abstaining from CC and ECIG, and provide initial effect size data for a brief intervention, thus providing necessary data for a large-scale follow-up trial. Clinical Trials ID: NCT05306158., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Low dose computed tomography (LDCT) is an effective screening test to decrease lung cancer deaths. Lung cancer screening may be a teachable moment helping people who smoke to quit, which may result in increased benefit of screening. Innovative strategies are needed to engage high-risk individuals in learning about LDCT screening. More precise methods such as polygenic risk scores quantify genetic predisposition to tobacco use, and optimize lung health interventions. We present the ESCAPE (Enhanced Smoking Cessation Approach to Promote Empowerment) protocol. This study will test a smoking cessation intervention using personal stories and a lung cancer screening decision-aide compared to standard care (brief advice, referral to a quit line, and a lung cancer screening decision-aide), examine the relationship between a polygenic risk score and smoking abstinence, and describe perceptions about integration of genomic information into smoking cessation treatment. A randomized controlled trial followed by a sequential explanatory mixed methods approach will compare the efficacy of the interventions. Interviews will add insight into the use of genomic information and risk perceptions to tailor smoking cessation treatment. Two-hundred and fifty individuals will be recruited from primary care, community-based organizations, mailing lists and through social media. Data will be collected at baseline, 1, 3 and 6-months. The primary outcomes are 7-day point prevalence smoking abstinence and stage of lung cancer screening at 6-months. The results from this study will provide information to refine the ESCAPE intervention and facilitate integration of precision health into future lung health interventions. Clinical trial registration number: NCT0469129T., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

A majority of the 34 million people who currently smoke cigarettes report wanting to quit smoking yet most attempts to quit end in relapse. A mindfulness based intervention (MBI) is an intervention package used to reinforce an individual's practice of mindfulness meditation in daily life. MBIs delivered by phone app offer daily prompts to guide bouts of mindfulness meditation, that is, sustained attention to moment-by-moment experience without behavior reactivity. Daily bouts of mindfulness meditation offer individuals a replacement behavior for smoking during a quit attempt, and MBI app instruction aims to increase an individual's skill in non-reactivity when they experience cravings. Our study objective is to test the effect of an app-based MBI on abstinence during a scheduled quit attempt among people who currently smoke and who are willing to make a voluntary quit attempt on a selected near-term date. Our delivery of a smartphone app-based MBI occurs daily for the two weeks preceding a planned quit date. Study participants are randomized to an app-based MBI or psychoeducation control group and asked to self-administer their intervention two times a day in 10-min segments for 14 sequential days for a total of 280 min. This preparatory period capitalizes on time to help participants orient toward a near-term goal to quit smoking, practice mindfulness meditation, and increase the skill of non-reactivity during states of craving to smoke. We recruit people who smoke cigarettes from all 58 counties in California. We test the hypothesis that an app-based MBI will outperform a time-matched psychoeducation control on increasing smoking abstinence. Findings contribute knowledge to the addictions treatment field about whether MBIs delivered by app can increase smoking cessation in a geographically-diverse sample., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

In the midst of the COVID-19 pandemic, many research and clinical teams have transitioned their projects to a remote-based format, weighing the pros and cons of making such a potentially disruptive decision. One key aspect of this decision is related to the patient population, with underserved populations possibly benefiting from the increased reach of telehealth, while also encountering technology barriers that may limit accessibility. Early in the pandemic, our team shifted a group-based, smoking cessation and alcohol modification treatment trial to a remote-based format. Our population included individuals who concurrently wanted to quit smoking and modify their alcohol use. This paper describes technical and logistical considerations of transitioning from in-person to remote-based delivery for group-based treatment, including the impact upon study staff, group facilitators, participants, and the institution. Remotely-delivered group treatment may be valuable not only in response to pandemic-related restrictions, but it may also offer an alternative treatment-delivery modality with independent benefits in terms of population reach, costs, and pragmatics for clients, staff, and institutions., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS., Methods: Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention., Discussion: Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers., (Copyright © 2021. Published by Elsevier Inc.)

Smoking is the leading preventable cause of death and disability in the U.S. Empirical evidence suggests that engaging in evidence-based self-regulatory strategies (e.g., behavioral substitution, mindful attention) can improve smokers' ability to resist craving and build self-regulatory skills. However, poor engagement represents a major barrier to maximizing the impact of self-regulatory strategies. This paper describes the protocol for Mobile Assistance for Regulating Smoking (MARS) - a research study designed to inform the development of a mobile health (mHealth) intervention for promoting real-time, real-world engagement in evidence-based self-regulatory strategies. The study will employ a 10-day Micro-Randomized Trial (MRT) enrolling 112 smokers attempting to quit. Utilizing a mobile smoking cessation app, the MRT will randomize each individual multiple times per day to either: (a) no intervention prompt; (b) a prompt recommending brief (low effort) cognitive and/or behavioral self-regulatory strategies; or (c) a prompt recommending more effortful cognitive or mindfulness-based strategies. Prompts will be delivered via push notifications from the MARS mobile app. The goal is to investigate whether, what type of, and under what conditions prompting the individual to engage in self-regulatory strategies increases engagement. The results will build the empirical foundation necessary to develop a mHealth intervention that effectively utilizes intensive longitudinal self-report and sensor-based assessments of emotions, context and other factors to engage an individual in the type of self-regulatory activity that would be most beneficial given their real-time, real-world circumstances. This type of mHealth intervention holds enormous potential to expand the reach and impact of smoking cessation treatments., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Smoking rates are disproportionately high among people living with HIV. Smokers living with HIV (SLWH) are also largely unaware of the HIV-specific deleterious effects of smoking and often lack motivation and confidence in their ability to quit tobacco. To address these issues, we developed the Wellness Intervention for Smokers Living with HIV (WISH). WISH is grounded in the Information-Motivation-Behavioral Skills (IMB) Model and is designed for all SLWH, regardless of their initial motivation to quit. It follows evidence-based, best practice guidelines for nicotine dependence treatment, but is innovative in its use of a comprehensive wellness approach that addresses smoking within the context of HIV self-management including treatment adherence and engagement, stress management, substance use, and other personally relevant health behavior goals. The described randomized trial will enroll SLWH who are receiving care at Veterans Affairs (VA) medical centers and compare WISH's impact on smoking behavior to standard care services offered through the National VA Quitline and SmokefreeVET texting program. It will also assess intervention impact on markers of immune status and mortality risk. If effective, WISH could be disseminated to Veterans nationwide and could serve as a model for designing quitline interventions for other smokers who are ambivalent about quitting. The current paper outlines the rationale and methodology of the WISH trial, one of a series of studies recently funded by the National Cancer Institute to advance understanding of how to better promote smoking cessation among SLWH., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximizing opportunities for extinction learning during a five-week pre-quit period. The primary aims of the RCT are to test the effects of the FE intervention versus a standard (cognitive-behavioral) intervention, while also comparing two nicotine reduction schedules for providing very low nicotine content (VLNC) cigarettes. The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers., Methods: BANSAR is a pragmatic randomised controlled trial conducted in antenatal clinic in seven public hospitals in Hong Kong, China. An estimated 1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking will be randomised (1:1) to receive brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care). Outcome will be assessed at 3 and 6 months after treatment initiation. The primary outcome is carbon monoxide-verified (<4 part per million) abstinence at 6 months post-treatment initiation. Secondary outcomes include self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers., Comment: This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population. The findings may be particularly relevant to low and middle-income countries, where male-to-female smoking ratios and birth rates tend to be higher than higher-income countries., Trial Registration: ClinicalTrials.gov, number NCT03671707., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Smoking in the United States follows a clear socioeconomic gradient: low-income Americans smoke more and quit less than those with more education and income. Evidence-based interventions like tobacco quitlines are designed to make effective cessation services available on a population basis to all smokers. However, these interventions do not address many of the unique challenges faced by low-income smokers, including unmet basic needs like food, housing, personal safety and money for necessities that often supersede health needs. Research is needed to maximize the use and effectiveness of tobacco quitlines in low-income populations. This paper details the rationale, design and methods for a 2 × 2 randomized controlled trial currently underway comparing the effects of Standard and Specialized Tobacco Quitlines with and without Basic Needs Navigation on intervention engagement and smoking cessation among low-income smokers. Smokers are recruited from United Way 2-1-1 in Missouri and all participants receive tobacco quitline services from Optum. Quitline and navigation services are provided for 3 months. Participants complete telephone surveys at baseline, 3- and 6-month follow up. The primary study outcome is self-reported 7-day point prevalence abstinence at 6-month follow up. Embedding the study in practice agencies will accelerate dissemination and scalability should our findings demonstrate intervention effectiveness., (Copyright © 2019. Published by Elsevier Inc.)

Background: Novel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g., WhatsApp, Facebook Messenger) are widely used but under-studied as a mobile health modality for delivering smoking cessation support. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a chat-based intervention using mobile instant messaging combined with brief interventions for community smokers., Methods: This is a two-arm, parallel, accessor-blinded, pragmatic cluster-randomized controlled trial on an estimated 1172 daily cigarette smokers aged ≥18 years proactively recruited from 68 community sites (cluster) throughout Hong Kong. Subjects in intervention group received three months of chat-based, instant messaging support guided by acceptance and commitment therapy and other behavioural change techniques, integrated with brief advice and active referral to a smoking cessation service using the AWARD (Ask, Warn, Advise, Refer, Do-it-again) intervention model. Control group received brief advice to quit plus a self-help booklet at baseline. Outcomes were assessed at 1-, 2-, 3- and 6-month after baseline. The primary outcome is abstinence validated by exhaled carbon monoxide (<4 ppm) and salivary cotinine (<10 ng/mL) at 6-month after baseline. Primary analyses will be based on intention-to-treat., Comments: This is the first trial examining the effectiveness of a chat-based cessation support programme combined with brief interventions in promoting abstinence. The intervention model can be adapted for other behavioural change treatments and more advanced digital smoking cessation intervention., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml., (Copyright © 2018. Published by Elsevier Inc.)

Background: Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study., Methods: In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST)., Results: The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5)., Conclusions: The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders., (Copyright © 2017 Elsevier Inc. All rights reserved.)

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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers., Methods/design: A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST., Discussion: This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients., (Copyright © 2016. Published by Elsevier Inc.)

Background: Dutch practice nurses sub-optimally adhere to evidence-based smoking cessation guidelines. Web-based computer-tailoring could be effective in improving their guideline adherence. Therefore, this paper aims to describe the development of a web-based computer-tailored program and the design of a randomized controlled trial testing its (cost-)effectiveness., Methods: Theoretically grounded in the I-Change Model and Self-Determination Theory, and based on the results of a qualitative needs assessment among practice nurses, a web-based computer-tailored program was developed including three modules with tailored advice, an online forum, modules with up-to-date information about smoking cessation, Frequently Asked Questions (FAQs) and project information, and a counseling checklist. The program's effects are assessed by comparing an intervention group (access to all modules) with a control group (access to FAQs, project information and counseling checklist only). Smoking cessation guideline adherence and behavioral predictors (i.e. intention, knowledge, attitude, self-efficacy, social influence, action and coping planning) are measured at baseline and at 6- and 12-month follow-up. Additionally, the program's indirect effects on smokers' quit rates and the number of quit attempts are assessed after 6 and 12months., Discussion: This paper describes the development of a web-based computer-tailored adherence support program for practice nurses and the study design of a randomized controlled trial testing its (cost-)effectiveness. This program potentially contributes to improving the quality of smoking cessation care in Dutch general practices. If proven effective, the program could be adapted for use by other healthcare professionals, increasing the public health benefits of improved smoking cessation counseling for smokers., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites' adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; and 3302 employees across the worksites participated in the baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks' effectiveness., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The prevalence of smoking in methadone-maintained (MM) patients is over 80% and smoking-abstinence rates are strikingly low, even with the use of first-line smoking-cessation medications. Research has found that cigarettes increase the reinforcing properties of methadone; this interaction may be an additional, daily, challenge to smoking cessation in MM-smokers. This paper describes a novel approach in which patients who experience a particular barrier to achieving smoking abstinence are selected, and the impact of smoking-cessation medications on the identified barrier is evaluated. This is a 7-week, outpatient, randomized, within-subject, placebo-controlled, crossover trial with a follow-up visit at week 8. MM-smokers, who smoke ≥40% of their total daily cigarettes in the 4-h post-methadone-dosing period, as assessed with a Quitbit electronic cigarette lighter, will be recruited from a methadone program in Cincinnati, Ohio. Eligible participants will be randomized to receive four interventions (nicotine nasal spray (1mg per dose, up to 40 times per day), placebo nicotine nasal spray, varenicline (2mg/day), and varenicline placebo) in one of four orders to mitigate potential order effects. The primary outcome analysis will consist of two sets of statistical analyses, one comparing the effect of nicotine nasal spray to its placebo, and one comparing the effect of varenicline to its placebo, on the proportion of daily cigarettes smoked during the 4-h post-methadone-dosing period. This trial is of interest both as an efficient, precision-medicine-based approach to testing smoking-cessation interventions and as a specific strategy for identifying effective smoking-cessation treatment for MM-smokers., (Copyright © 2016. Published by Elsevier Inc.)

Unlabelled: Smoking cessation is one of the most powerful preventive interventions available to primary care providers. Rates of tobacco treatment delivery in primary care settings, however, remain sub-optimal. This paper reports on rationale, design, and protocol for a matched-paired, cluster-randomized controlled trial to compare the incremental effectiveness of performance coaching on physician delivery of smoking cessation assistance when delivered as part of a practice-level intervention for smoking cessation (the Ottawa Model for Smoking Cessation; OMSC). Outcome measures included frequency of provider smoking cessation treatment delivery, patient quit attempts, and 7-day point prevalence abstinence measured at 6 months, and changes in provider attitudes and beliefs related to smoking cessation treatment delivery. Primary care clinics were randomly assigned, using a matched paired design, to one of two treatment conditions: OMSC Group or OMSC+Performance Coaching Group. All practices were supported with implementing the OMSC. Half of the practices also received a 1.5 hour, skills-based, coaching session to address barriers encountered in the delivery of smoking cessation treatments and individualized performance feedback reports. All providers, and a cross sectional sample of patients from their practices, were surveyed before and after the implementation of the intervention. Multi-level modeling was used to compare intervention groups. If shown to be effective, the study will lead to an improved understanding of how to best assist clinicians to enhance the delivery of smoking cessation practice and will provide evidence to guide the design of smoking cessation interventions in primary care., Trial Registration: clinicaltrials.gov Identifier: NCT01603524., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: Combining behavioural support and pharmacotherapy is most effective for smoking cessation and recommended in clinical guidelines. Despite that smoking cessation assistance from the general practitioner can be effective, dissemination of clinical practice guidelines and efforts on upskilling has not lead to the routine provision of smoking cessation advice among general practitioners. Intensive counselling from the practice nurse could contribute to better smoking cessation rates in primary care. However, the effectiveness of intensive counselling from a practice nurse versus usual care from a general practitioner in combination with varenicline is still unknown., Materials and Methods: A pragmatic randomized controlled trial was conducted comparing: (a) intensive individual counselling delivered by a practice nurse and (b) brief advice delivered by a general practitioner; both groups received 12-weeks of open-label varenicline. A minimum of 272 adult daily smoking participants were recruited and treated in their routine primary care setting. The primary outcome was defined as prolonged abstinence from weeks 9 to 26, biochemically validated by exhaled carbon monoxide. Data was analysed blinded according to the intention-to-treat principle and participants with missing data on their smoking status at follow-up were counted as smokers. Secondary outcomes included: one-year prolonged abstinence, short-term incremental cost-effectiveness, medication adherence, and baseline predictors of successful smoking cessation., Discussion: This trial is the first to provide scientific evidence on the effectiveness, cost-effectiveness, and potential mechanisms of action of intensive practice nurse counselling combined with varenicline under real-life conditions. This paper explains the methodology of the trial and discusses the pragmatic and/or explanatory design aspects., Trial Registration: Dutch Trial Register NTR3067., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiveness and cost-effectiveness of integrated telemedicine counseling delivered by 2-way webcams mounted on desktop computers in participant's physician office examining rooms (ITM) versus quitline counseling delivered by telephone in participant's homes (Phone) for helping rural smokers quit., Methods/design: C2Q was implemented in twenty primary care and safety net clinics. Integrated telemedicine consisted of real-time video counseling, delivered to patients in their primary care physician's (PCP) office. Phone counseling, was delivered to patients in their homes. All participants received educational materials and guidance in selecting cessation medications., Results: The 566 participants were predominantly Caucasian (92%); 9% were Latino. Most (65%) earned <200% of Federal Poverty Level. One out of three lacked home internet access, 40% were not comfortable using computers, and only 4% had been seen by a doctor via telemedicine in the past. Hypertension, chronic lung disease, and diabetes were highly prevalent. Participants smoked nearly a pack a day and were highly motivated to quit., Discussion: C2Q is reaching a rural low-income population, with comorbid chronic diseases, that would benefit greatly from quitting smoking. ITM is a good delivery model, which integrates care by holding counseling sessions in the patient's PCP office and keeps the primary care team updated on patients' progress., Clinical Trials Registration: NCT00843505., (Published by Elsevier Inc.)

Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Quitting smoking is the single most effective strategy to reduce morbidity and premature mortality in smokers. Research has demonstrated the effectiveness of pharmacotherapy in smoking cessation, but few studies have directly compared varenicline and monotherapy nicotine replacement therapy (NRT) and none have examined varenicline and combinations of NRT products. The majority of smoking cessation trials involve carefully circumscribed populations, making their results less generalizable to those with severe medical conditions or psychiatric comorbidities. This paper reports on the rationale, methodology and participant characteristics of a randomized controlled trial designed to: (1) determine which pharmacotherapy - NRT, long term combinations of NRT, or varenicline - is most effective in achieving abstinence; (2) investigate the incidence of neuropsychiatric symptoms among participants over the course of their quit attempt; and (3) assess whether there is a significant difference in the incidence of neuropsychiatric symptoms in those receiving differing pharmacotherapies, and between those with and without psychiatric illnesses. The primary outcome was carbon monoxide confirmed abstinence from weeks 5-52 following a target quit date. Secondary outcomes included neuropsychiatric (i.e., depression, suicidal ideation, anxiety, anger) and withdrawal symptoms. Smokers (N=737) were randomly assigned to one of three treatment conditions, and were scheduled to attend 8 follow-up appointments over 12 months. All participants received 6-15 minute practical counseling sessions with nurse counselors experienced in treating tobacco dependence. We expect that the results will lead to an enhanced understanding of the efficacy of these pharmacotherapies, including those with a history of psychiatric illness., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Smoking cessation is a primary method of reducing excess mortality and morbidity. Unfortunately, the vast majority of cessation attempts end in eventual relapse. Relapse-prevention interventions have shown some success at improving the long-term maintenance of tobacco abstinence among individuals motivated to abstain. However, involuntary tobacco abstinence (e.g., military training, hospitalization, incarceration) presents another opportunity for intervention to prevent relapse. During basic military training (BMT), tobacco use is strictly forbidden in all service branches, but tobacco relapse (and initiation) following BMT is extremely high. This paper reports on the design, intervention development, and baseline characteristics of a randomized controlled trial testing minimal interventions designed to prevent tobacco relapse among United States Air Force (USAF) personnel following BMT. Participants are randomized by squadron to receive either a standard smoking-cessation booklet, a new motivation-based booklet designed specifically for USAF personal, or the latter booklet combined with a brief, face-to-face motivational session. Primary outcomes will be self-reported tobacco use at 12 and 24month follow-up. Given that the Department of Defense is the world's largest employer, the potential of leveraging involuntary tobacco abstinence during BMT into extended abstinence has substantial public health significance., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)--an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants' natural environments., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Thirty percent of all military personnel smoke cigarettes. Because of the negative health consequences and their impact on physical fitness, overall health, and military readiness, the Department of Defense has identified the reduction of tobacco use as a priority of US military forces. This study aims to evaluate the one-year efficacy of a proactive versus reactive smoking quit line in the US military with adjunctive nicotine replacement therapy (NRT) in both groups. This paper reports on the baseline variables of the first 1000 participants randomized, the design, and proposed analysis of the randomized two-arm clinical trial "Efficacy of a Tobacco Quit Line in the Military". Participants are adult smokers who are Armed Forces Active Duty personnel, retirees, Reservist, National Guard and family member healthcare beneficiaries. All participants are randomized to either the Counselor Initiated (proactive) group, receiving 6 counseling sessions in addition to an 8-week supply of NRT, or the Self-Paced (reactive) group, in which they may call the quit line themselves to receive the same counseling sessions, in addition to a 2-week supply of NRT. The primary outcome measure of the study is self-reported smoking abstinence at 1-year follow-up. Results from this study will be the first to provide evidence for the efficacy of an intensive Counselor Initiated quit line with provided NRT in military personnel and could lead to dissemination throughout the US Air Force, the armed forces population as a whole and ultimately to civilian personnel that do not have ready access to preventive health services., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Effective interventions are needed to improve smokers' motivation for quitting, treatment utilization, and abstinence rates. The Internet provides an ideal modality for delivering such interventions, given the low cost, broad reach, and capacity to individually tailor content, but important methodological questions remain about how to best design and deliver an online, motivational intervention to smokers. The current paper reports on the intervention, study design and research methods of a randomized trial (called Questions about Quitting) designed to address some of these questions. Using a Multi-phase Optimization Strategy (MOST) screening experiment, the trial has two key aims: to examine the impact of four experimental intervention factors (each evaluated on two levels) on smokers' subsequent treatment utilization and abstinence, and to examine select moderators of each sub-factor's effectiveness. The experimental factors of interest are: navigation autonomy (content viewing order is dictated based on stage of change or not), use of self-efficacy based testimonials (yes vs. no), proactive outreach (reminder emails vs. no emails), and decisional framework (prescriptive vs. motivational tone). To our knowledge, this is the first application of the MOST methodology to explore these factors or to explore the optimal design for a motivational intervention targeting smokers not actively trying to quit smoking. The rationale for the experimental factor choice, intervention design, and trial methods are discussed. Outcome data are currently being collected and are not presented, but recruitment data confirm the feasibility of enrolling smokers at varying stages of readiness to quit., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Cigarette smoking is prevalent in cocaine/methamphetamine-dependent patients and associated with significant morbidity and mortality, yet, the provision of smoking cessation treatment in conjunction with substance use disorder (SUD) treatment is not standard practice. This is due, in part, to clinician concern that combining smoking cessation treatment with SUD treatment could lead to poorer SUD outcomes. The NIDA Clinical Trials Network is conducting a 10-week, two-group, randomized trial to evaluate the impact of providing smoking cessation treatment (SCT) with SUD treatment as usual (TAU), compared to TAU alone, in smokers who are in outpatient treatment for cocaine or methamphetamine dependence. Approximately 528 participants, recruited from 12 community treatment programs, will be randomized into the trial. The present paper describes key design decisions made during protocol development. The trial is designed to evaluate the relationship between cigarette smoking and stimulant use, which prior research suggests is linked, and should contribute to our understanding of how best to address the co-occurring problems of nicotine dependence and cocaine/methamphetamine-dependence. Unique aspects of the trial include the primary question of interest, which concerns the impact of providing SCT on SUD outcomes rather than on smoking outcomes, and the intensity of the SCT chosen, which includes bupropion, nicotine replacement, and two psychosocial interventions., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: The SQ4U (Stay Quit for You)-study aims to test the efficacy of two computer tailored smoking relapse prevention programs which incorporate planning strategy assignments and provide tailored feedback at multiple time points after the quit-attempt. The programs differ in the support provided after the quit-attempt. This paper aims to describe the development and design of SQ4U., Methods/design: SQ4U-respondents were daily smokers in the 18-65 years age group, who were motivated to quit smoking and willing to make a quit-attempt within 1 month of registration. The study is a randomized controlled trial with three conditions: 1. Control group, 2. Action planning (AP) program, 3. Action planning plus (AP+) program. Respondents in the control group only filled out questionnaires. The AP program consisted of computer tailored baseline feedback based on the I-Change Model and six planning strategy assignments. The AP+ program provided the same program elements as the AP program, but was extended with tailored feedback at eleven time points after the quit-attempt. The feedback targeted (recovery) self-efficacy, planning and negative affect. There were two follow-up measurements at 6 and 12 months after baseline. User experiences and the efficacy of the programs in fostering seven-day point prevalence and continued abstinence were examined using a process evaluation and logistic regression analyses., Discussion: The present paper outlines the development and design of the SQ4U-study. This study has the potential to provide a new effective computer tailored smoking relapse prevention program as well as insight into effective smoking relapse prevention strategies., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: PAS (Personal Advice in Stopping smoking) combines two of the most effective smoking cessation interventions: multiple computer tailoring and tailored counselling by a practice nurse in the general practice., Methods/design: Since May 2009, practice nurses are recruiting smoking patients. Each practice nurse is asked to recruit 15 adult smokers who are willing to quit within 6months and have access to the Internet. Smokers can sign up for PAS through the PAS website and are then randomized into one of three groups receiving multiple tailoring and counselling (MTC), multiple tailoring (MT) or usual care (UC), respectively. All groups receive questionnaires at baseline, 2days after a set quit date and at 6weeks, 6months and 12months follow-up. The MT group receives tailored, iterative feedback letters at the first four measurements points. At 12months follow-up biochemical validation will take place amongst respondents reporting to have quit. The three groups will be compared with regard to quit attempt rate, point prevalence abstinence and continued abstinence by means of logistic multilevel regression analyses. Linear multilevel regression analyses will be used to compare the three groups regarding smoking related beliefs., Discussion: The present paper provides an extensive description of the development of PAS and of the design of the study towards its effectiveness. This might provide insight into PAS' potentially effective working mechanisms. The results concerning effectiveness may contribute to knowledge about the effectiveness of smoking cessation interventions aimed at smoking adults., Trial Registration: Dutch Trial Register NTR1351., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are recruited via the Oregon, Nebraska and Louisiana state-sponsored tobacco quitlines and randomized to receive standard quitline care versus standard care plus a multi-modal oral health promotion program (Oral Health 4 Life) integrated within the quitline services. All participants are followed for 6 months to assess the impact of the intervention on smoking abstinence and utilization of professional dental care. In addition, the study will assess the cost of the intervention and provide practical guidance to states on whether the intervention is financially feasible to implement, should the intervention be effective. This study protocol may be useful to others interested in promoting oral health among smokers, those interested in partnering with tobacco quitlines to extend standard services to address other high risk health behaviors among smokers, or those interested in semi-pragmatic trial design. [ABSTRACT FROM AUTHOR]

Abstract: Several randomized trials have found behavior change programs delivered via text messaging to be efficacious to improve preventive health behaviors such as physical activity and stopping smoking; however few have assessed its value in skin cancer prevention or early detection. The HealthyTexts study enrolled 678 participants 18–42years, and assigned them to receive 21 text messages about skin cancer prevention, skin self-examination or physical activity (attention control) over the course of one year. Baseline data have been collected and outcomes will be assessed at three months and twelve months post-intervention. The trial aims to increase the mean overall sun protection habits index score from 2.3 to 2.7 with a standard deviation of 0.5 (effect size of 0.5) and the proportion of people who conduct a whole-body skin self-examination by an absolute 10%. This paper describes the study design and participants' baseline characteristics. In addition, participants' goals for their health, and strategies they apply to achieve those goals are summarized. [Copyright &y& Elsevier]

Abstract: Effective interventions are needed to improve smokers'' motivation for quitting, treatment utilization, and abstinence rates. The Internet provides an ideal modality for delivering such interventions, given the low cost, broad reach, and capacity to individually tailor content, but important methodological questions remain about how to best design and deliver an online, motivational intervention to smokers. The current paper reports on the intervention, study design and research methods of a randomized trial (called Questions about Quitting) designed to address some of these questions. Using a Multi-phase Optimization Strategy (MOST) screening experiment, the trial has two key aims: to examine the impact of four experimental intervention factors (each evaluated on two levels) on smokers'' subsequent treatment utilization and abstinence, and to examine select moderators of each sub-factor''s effectiveness. The experimental factors of interest are: navigation autonomy (content viewing order is dictated based on stage of change or not), use of self-efficacy based testimonials (yes vs. no), proactive outreach (reminder emails vs. no emails), and decisional framework (prescriptive vs. motivational tone). To our knowledge, this is the first application of the MOST methodology to explore these factors or to explore the optimal design for a motivational intervention targeting smokers not actively trying to quit smoking. The rationale for the experimental factor choice, intervention design, and trial methods are discussed. Outcome data are currently being collected and are not presented, but recruitment data confirm the feasibility of enrolling smokers at varying stages of readiness to quit. [Copyright &y& Elsevier]