Self-reported 7-day Point Prevalence Abstinence Research Articles

Evaluating the Impact of a Game (Inner Dragon) on User Engagement Within a Leading Smartphone App for Smoking Cessation: Randomized Controlled Trial.

Smartphone apps are a convenient, low-cost approach to delivering smoking cessation support to large numbers of individuals. Yet, the apps are susceptible to low rates of user engagement and retention. This study aims to test the effects of a new game module (called Inner Dragon) integrated into Smoke Free (23 Limited), a leading smoking cessation app with established efficacy. The primary outcomes measured user engagement with the app. A 2-arm, parallel-group, randomized controlled trial was conducted in the United States with an 8-week follow-up. Adult individuals who smoked ≥1 cigarettes daily and planned to quit smoking within 7 days were recruited and randomized (N=500), with equal allocation. Both groups received free access to the original Smoke Free app with "core" features of its smoking cessation program (eg, a diary and craving log). The treated group received additional access to the integrated Inner Dragon game that incorporated several game mechanics designed to increase user engagement. User engagement outcomes were the number of unique app sessions, average minutes per session, days with a session, and program adherence. Self-reported and verified smoking abstinence and app satisfaction were also assessed. The main analysis estimated the intention-to-treat effect of access to Inner Dragon on each outcome. Further analyses assessed effect modification by participant characteristics and the association of intensity of game use with program adherence and abstinence. Overall, user engagement was greater for treated versus control participants: they had 5.3 more sessions of Smoke Free (mean 29.6, SD 36.5 sessions vs mean 24.3, SD 37.9 sessions; P=.06), 0.8 more minutes per session (mean 6.9, SD 5.4 min vs mean 6.1, SD 5.2 min; P=.047), and 3.4 more days with a session (mean 14.3, SD 15.3 days vs mean 11.9, SD 14.3 days; P=.03). Program adherence, based on the number of times core features of the original Smoke Free app were used, was higher for treated versus control participants (mean 29.4, SD 41.3 times vs mean 22.6, SD 35.6 times; P=.03). Self-reported 7-day and 30-day point-prevalence abstinence and verified 7-day point-prevalence abstinence at 8 weeks did not significantly differ by study group. The mean repeated 1-day prevalence of quitting was higher among the treated group versus the control group (mean 17.3%, SD 25.6 vs mean 12.4%, SD 21.3; P=.01). App satisfaction and the motivation to (stay) quit did not differ by study group. Higher intensity of game use was associated with increased program adherence and self-reported abstinence. Findings suggest that the Inner Dragon game increased user engagement and program adherence. Additional refinements to the game design may clarify whether the game increases abstinence rates. Overall, it is feasible to deploy games and gamification to enhance user engagement in existing smoking cessation interventions. ClinicalTrials.gov NCT05227027; https://clinicaltrials.gov/study/NCT05227027.

Testing the effectiveness of a virtual sustained tobacco treatment: Initial reporting of findings from the EAQ171CD randomized clinical trial conducted by ECOG-ACRIN within the NCI Community Oncology Research Program (NCORP).

376 Background: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet clinical guidelines for tobacco use interventions have not been integrated into community oncology settings. We conducted a trial of a virtual sustained tobacco treatment intervention across community oncology settings nationally. Methods: This randomized clinical trial, conducted through ECOG-ACRIN, compared the effectiveness of sustained telehealth counseling plus medication (Virtual Sustained Treatment; VST) to referral to the NCI quitline (Enhanced Usual Care; EUC) in assisting recently diagnosed cancer patients to quit smoking. The VST group received up to 11 synchronous telehealth sessions (4 weekly, 4 biweekly, 3 monthly) of motivational counseling and up to 12-weeks of free NRT patch and/or lozenge. Eligibility criteria included adults within 4 months of a new cancer diagnosis, cigarette use in the past 30 days, English/Spanish speaking, and access to an internet-enabled device. The primary outcome is 6-month self-reported 7-day point prevalence abstinence. Results: From 08/2019 to 12/2022, 306 patients were randomized from 30 NCORP Community Sites and 7 Minority/Underserved NCORP sites. Participants were 70.9% female; 86.3% White; 8.8% Black; and 2.9% Hispanic; median age 57 years; 25.5% completed a college degree; 50.3% stages 0-2; 46.4% had non-smoking-related tumors. Median cigarettes per day was 12.0; 72.2% (n = 221/306) smoked within 30 minutes of waking; 49.0% (n = 150/306) were in precontemplation/contemplation stage of readiness to quit. 73.8% (222/301) and 72.2% (210/291) completed the 3 and 6-month outcome assessments. Classifying missing smoking status as smokers, 6-month abstinence rates were 28.4% (42/148) in the VST group vs. 14.7% (21/143) in the EUC group (p<.005). For secondary outcomes, there were no significant differences when adjusted for multiple comparisons (α = 0.0025); abstinence at 3-months was 24.7% (38/154) in the VST group vs. 15.0% (22/147) in the EUC group (p=.035); continuous abstinence at 6 months was 18.9% (28/148) in the VST vs 9.1% (13/143) in the EUC (p=.016). 80.8% (126/156) of individuals randomized to VST participated in counseling; of those, 59.5% (75/126) completed at least 6 sessions, 46.0% (58/126) completed at least one monthly booster session, and 85.7% (108/126) were dispensed 4 weeks of NRT. Conclusions: Among recently diagnosed cancer patients, sustained remotely delivered telehealth counseling and free NRT produced a significantly higher 6-month quit rate than a quitline referral. Findings support adopting a policy of widespread sustained tobacco treatment and implementation of tobacco treatment into community oncology care settings nationwide. Clinical trial information: NCT03808818 .

A randomized controlled trial evaluation of a smoking cessation and physical activity intervention delivered via telemedicine in the Norton Sound region of Alaska

ObjectivesTobacco use disproportionately affects Alaska Native people. Physical activity may aid quitting smoking and provides health benefits. We tested telemedicine-delivered heart health interventions in Alaska’s Norton Sound region. MethodsAlaska Native adults (N = 299, 51.5 % male, 60.5 % Inupiaq) with hypertension and/or hypercholesterolemia who smoked daily were randomized to intervention on smoking and physical activity (group 1) or traditional diet and medication adherence (group 2). Intention to change was not required for participation. Stage-tailored mailed workbooks and personalized reports were supported by telehealth counseling at baseline, 3, 6, and 12 months. Study outcomes were assessed at baseline, 3-, 6-, 12-, and 18-months (i.e., 6-months after the final counseling session). Smoking outcomes were self-reported 7-day point prevalence abstinence (7d-PPA),11Abbreviations:7d-PPA: 7-day point prevalence abstinenceMET: Metabolic equivalent of taskMVPA: Moderate-to-vigorous physical activityNRT: Nicotine replacement therapy. bioconfirmed with urine anabasine; 24-hour quit attempts; and 50 % reduction in smoking. Self-reported physical activity outcomes were metabolic equivalent of task (MET) minutes and meeting moderate-to-vigorous physical activity (MVPA) guidelines. ResultsAt baseline, participants averaged 12.4 (SD = 10.0) cigarettes/day, with 19.4 % prepared to quit smoking, and 81.6 % meeting MVPA guidelines. During the study, most (70.2 % group 1; 63.5 % group 2) reported a 24-hr quit attempt (p = 0.219), and Group 1 (53.6 %) was more likely than Group 2 (28.4 %) to use nicotine replacement therapy (NRT), OR = 2.92, p < 0.001. At 18-months, 40.5 % (group 1) and 32.5 % (group 2) had reduced their smoking by half or more (p = 0.343), and 10.8 % vs. 7.9 % (group 1 vs. 2) reported 7d-PPA with 4 % vs. 6 % (group 1 vs. 2) bioconfirmed. Time and baseline stage of change predicted 7d-PPA (p’s≤.015), with no group effect (p = 0.325). Activity levels did not significantly differ by group or time. ConclusionsTelemedicine counseling supported NRT use but did not significantly affect behavioral outcomes.

Abstract B017: Kick Vaping: Feasibility, acceptability, and preliminary impact of a vaping cessation text messaging intervention for Latino young adults

Abstract Objective: The purpose of this study was to assess the feasibility, acceptability, and preliminary impact of Kick Vaping among Latino young adults. Methods: Forty Latino young adults (ages 18 to 25) who were currently vaping received Kick Vaping, a vaping cessation text messaging intervention available in English and Spanish. Feasibility was measured by the eligibility rate (defined as the proportion of individuals screened who were eligible), enrollment rate (the proportion of eligible individuals who enrolled), and follow-up rate (the proportion of participants who completed the follow-up assessment at Month 3). Acceptability was measured by overall satisfaction with the intervention and perceived helpfulness. Preliminary impact was measured by self-reported 7-day point prevalence abstinence (not vaping, even a single puff, in the past seven days) and changes in self-efficacy. Results: A total of 203 individuals were identified, 61 completed the eligibility assessment, and 55 were eligible to participate in the study. Forty individuals consented to participate in the study and enrolled in Kick Vaping. The eligibility and enrollment rates were 30.0% (61/203) and 72.7% (40/55), respectively. At baseline, participants’ mean age was 22.3 years old (SD 2.1), 45.0% of participants were female, and 45.0% were heterosexual or straight. Half of the participants had a high school education or less (50.0%) and were currently employed. Fourteen (35.0%) participants reported speaking English and Spanish equally. Most participants used disposable devices (70%), vaped daily (97.5%), had low (37.5%) or medium (35.0%) e-cigarette dependence, and had attempted to quit in the past year (72.5%). At Month 3, the follow-up rate was 90% (36/40). Treating those lost to follow-up as participants who continued vaping, 75% (30/40) of participants self-reported 7-day point prevalence abstinence. Self-efficacy mean scores significantly increased from 30.65 (SD 8.07) at baseline to 50.11 (SD 10.57) at follow-up (p&amp;lt;0.01). Moreover, most participants (88.9%, 32/36) reported being satisfied/extremely satisfied with Kick Vaping. Additionally, most participants (83.3%, 30/36) reported that the intervention included “just the right amount of messages”. Lastly, most participants (86.1%, 31/16) reported that Kick Vaping helped them quit vaping “a lot”. Conclusion: It is feasible to recruit and retain Latino young adults in a vaping cessation text messaging intervention. Moreover, Kick Vaping generated high satisfaction and perceived helpfulness among Latino young adults, significantly increased self-efficacy, and resulted in a notable vaping cessation rate at Month 3. Additional testing in a randomized clinical trial is warranted to assess the efficacy of the intervention. Citation Format: Rafael H. Orfin, Jeffrey Wilmer Ramos Santiago, Ritsel Decena Soriano, Eliany Romero Acosta, Diana Bermudez, Yaneth L. Rodriguez, Dongmei Li, Irfan Rahman, Scott McIntosh, Deborah J. Ossip, Ana Paula Cupertino, Francisco Cartujano-Barrera. Kick Vaping: Feasibility, acceptability, and preliminary impact of a vaping cessation text messaging intervention for Latino young adults [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B017.

Abstract B019: A machine learning approach to predicting smoking cessation outcomes among Spanish-speaking smokers who completed a culturally targeted intervention

Abstract Introduction: Among the Hispanic/Latinx population in the US, four of five leading causes of death are attributed to smoking. Few evidence-based interventions have been developed to improve smoking cessation for this population. Our team has demonstrated the efficacy of a culturally targeted, extended self-help intervention for Spanish-speaking smokers, estimating a smoking abstinence rate of 33% at 24 months, compared to 24% for usual care. Further efforts are needed to enhance this efficacious, low-cost, scalable intervention approach. Machine learning (ML) is one approach to increase understanding of the predictors of treatment outcomes and inform strategies to improve the intervention. Toward that goal, this secondary data analysis utilized the decision tree (DT) model to predict self-reported 7-day point prevalence abstinence at 18-month follow-up for participants receiving our intervention. Method: Data from participants who reported smoking status at an 18-month follow-up (N=332 of 714 enrolled, 36% abstinent) were randomly split (80:20) into training and test datasets based on smoking status. We entered demographics, psychosocial, and smoking variables collected at baseline as predictors in the model. In addition to handling missing values and normalizing numeric features, we employed the Synthetic Minority Over-sampling Technique (SMOTE) combined with Tomek links (SMOTE-Tomek) to improve inter-class separability. Recursive Feature Elimination (RFE) using DT was implemented to identify the most relevant predictors. The cross-validation (CV) pipeline incorporated preprocessing, feature selection, handling class-imbalance, over-sampling, and model training with a DT as the interpretable classifier. Hyperparameters were tuned using stratified K-fold (K=5) CV to optimize parameters using Grid search. F1 score was selected as the primary metric as it accounts for each class performance by combining the precision and recall metrics. Finally, the performance of the classifier was evaluated in 20% of the unseen dataset. Results: The DT classifier for the CV achieved the F1 score of 0.73 [95% CI 0.66, 0.77], revealing a reasonably good performance in identifying smokers at 18-months. RFE selected familism, age, affect, and confidence as the most relevant predictors of smoking status. Individuals who had lower familism scores (&amp;lt;138), combined with higher age (&amp;gt;50), were more likely to be smokers at 18 months. Individuals who had higher familism scores (&amp;gt;138) combined with higher negative affect (&amp;gt;42) were more likely to be smokers. Conclusion: This study provides the first step toward personalized care for smoking cessation among the Hispanic/Latinx population and demonstrates the potential of DT classifier to predict cessation outcomes among individuals who received and completed a culturally and linguistically targeted smoking cessation intervention. Our future analysis will compare this model with conventional statistical modeling approaches and other ML algorithms to identify the best-performing parsimonious model. Citation Format: Ranjita Poudel, K. Ruwani M. Fernando, Matthew B. Schabath, Steven K. Sutton, Thomas H. Brandon, Issam El Naqa, Vani N. Simmons. A machine learning approach to predicting smoking cessation outcomes among Spanish-speaking smokers who completed a culturally targeted intervention [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B019.

Kick Vaping: Feasibility, acceptability, and preliminary impact of a vaping cessation text messaging intervention for Latino young adults

Objective To assess the feasibility, acceptability, and preliminary impact of Kick Vaping among Latino young adults. Methods Forty Latino young adults (ages 18 to 25) who were currently vaping received Kick Vaping, a vaping cessation text messaging intervention available in English and Spanish. Feasibility was measured by the eligibility, enrollment, and follow-up rates. Acceptability was measured by overall satisfaction with the intervention. Preliminary impact was measured by self-reported 7-day point prevalence abstinence and changes in self-efficacy. Results Two hundred three individuals were identified, 61 were assessed for eligibility, and 55 were eligible. Forty individuals consented to participate and were enrolled in Kick Vaping. At baseline, most participants used disposable devices (70%), vaped daily (97.5%), had low (37.5%) or medium (35.0%) e-cigarette dependence, and had attempted to quit in the past year (72.5%). At Month 3, the follow-up rate was 90% (36/40). Treating those lost to follow-up as participants who continued vaping, 75% (30/40) of participants self-reported 7-day point prevalence abstinence. Self-efficacy mean scores significantly increased from 30.65 (SD 8.07) at baseline to 50.11 (SD 10.57) at follow-up (p < 0.01). Most participants (88.9%, 32/36) reported being satisfied/extremely satisfied with Kick Vaping. Conclusion It is feasible to recruit and retain Latino young adults in a vaping cessation text messaging intervention. Kick Vaping generated high satisfaction among Latino young adults, significantly increased self-efficacy, and resulted in a notable vaping cessation rate at Month 3. Additional testing in a randomized controlled trial is warranted to assess the efficacy of the intervention.

A Vaping Cessation Text Message Program for Adolescent E-Cigarette Users

E-cigarettes are the most commonly used tobacco product among adolescents. Despite known harms of nicotine exposure among teens, there are no empirically tested vaping cessation interventions. To compare the effectiveness of a text message program for nicotine vaping cessation among adolescents with assessment-only control. A parallel, 2-group, double-blind, individually randomized clinical trial with follow-ups at 1 and 7 months after randomization was conducted from October 1, 2021, to October 18, 2023. Participants were recruited via social media ads; the intervention was delivered via text message; and assessments were completed online or by telephone. Eligible individuals were US residents aged 13 to 17 years who reported past 30-day e-cigarette use, were interested in quitting within 30 days, and owned a mobile phone with an active text message plan. To optimize study retention, all participants received monthly assessments via text message about e-cigarette use. Assessment-only controls (n = 744) received only study retention text messages. Intervention participants (n = 759) also received an automated, interactive text message program for vaping cessation that delivers cognitive and behavioral coping skills training and social support. The primary outcome was self-reported 30-day point-prevalence abstinence from vaping at 7 months analyzed as intention-to-treat, with missingness coded as vaping. Among n = 1503 adolescents randomized, average age was 16.4 (SD, 0.8) years. The sample was 50.6% female, 42.1% male, and 7.4% nonbinary/other; 10.2% Black/African American, 62.6% White, 18.5% multiracial, and 8.7% another race; 16.2% Hispanic; 42.5% sexual minority; and 76.2% vaped within 30 minutes of waking. The 7-month follow-up rate was 70.8%. Point-prevalence abstinence rates were 37.8% (95% CI, 34.4%-41.3%) among intervention participants and 28.0% (95% CI, 24.9%-31.3%) among control participants (relative risk, 1.35 [95% CI, 1.17-1.57]; P < .001). No baseline variables moderated the treatment-outcome relationship. There was no evidence that adolescents who quit vaping transitioned to combustible tobacco products. A tailored, interactive text message intervention increased self-reported vaping cessation rates among adolescents recruited via social media channels. ClinicalTrials.gov Identifier: NCT04919590.

Mobile Phone–Based Personalized and Interactive Augmented Reality Pictorial Health Warnings for Enhancing a Brief Advice Model for Smoking Cessation: Pilot Randomized Controlled Trial

Background Augmented reality (AR) is a novel modality for promoting smoking cessation (SC). AR-visualized adverse consequences for education and smoking prevention have only been evaluated in nonsmokers in previous studies. Objective To assess the feasibility and preliminary effectiveness for SC of AR pictorial health warnings (PHWs) on cigarette packs. Methods We conducted a pilot randomized controlled trial in adult daily smokers in communities in Hong Kong. All participants received AWARD (ask, warn, advise, referral, do-it-again) model–guided SC advice, a warning leaflet, and referral to SC services at baseline. Interactive, chat-based SC support comprising regular messages and real-time support was provided to all participants via instant messaging apps (eg, WhatsApp) for 3 months after randomization. Participants in the intervention group additionally received 6 links to the AR PHWs showing the worsening health status of various organs caused by smoking. The level of the AR PHWs was adjustable to smoking behaviors (ie, smoking duration or daily cigarette consumption) to increase interaction. Participants could swipe, drag, or rotate the 3D PHWs to reinforce their impression of the health consequences of smoking. The primary outcome was self-reported past 7-day point-prevalence abstinence (PPA) at 3 months. The acceptability of the AR intervention was assessed by the proportion of participants who had viewed AR PHWs during the intervention. Participants who viewed AR PHWs further evaluated the perceived effect of the AR PHWs on a scale of 0 (not helpful at all) to 10 (very helpful). Intention to treat was used, and the risk ratio (RR) of the intervention effect was estimated by Poisson regression. Results From April to November 2021, 80 participants were recruited and randomly assigned to intervention (n=40) and control (n=40) groups. Most participants were male (66/80, 83%) and planned to quit beyond 30 days or were undecided (65/80, 81%). The intervention group had a higher but nonsignificant 7-day PPA (7/40, 18% vs 5/40, 13%; RR 1.40, 95% CI 0.48-4.07) and quit attempts (15/40, 38% vs 11/40, 28%; RR 1.36, 95% CI 0.71-2.60) at 3 months than the control group. In the intervention group, 17 of 40 (43%) participants viewed the AR PHWs. The AR PHWs had modest effects on knowledge of the adverse consequences of smoking on personal health (mean score 3.94, SD 3.52), reducing the frequency of buying cigarettes (mean score 3.29, SD 3.08), increasing the perceived importance of quitting (mean score 3.88, SD 3.50), and making the PHWs more disgusting (mean score 3.41, SD 3.08) and horrible (mean score 3.38, SD 3.05). The 3-month self-reported 7-day PPA was higher in those who ever (vs never) viewed the AR PHWs (5/17, 29% vs 2/23, 9%). Conclusions The mobile-based interactive AR PHWs were feasible, and the effectiveness on smoking abstinence warrants further testing. Trial Registration ClinicalTrials.gov NCT04830072; https://clinicaltrials.gov/study/NCT04830072

Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial.

Chinese immigrants experience significant disparities in tobacco use. Culturally adapted tobacco treatments targeting this population are sparse and the use is low. The low use of these treatment programs is attributed to their exclusive focus on individuals who are ready to quit and the wide range of barriers that Chinese immigrants face to access these programs. To support Chinese immigrant smokers at all levels of readiness to quit and address their access barriers, we developed the WeChat Quit Coach, a culturally and linguistically appropriate WeChat (Tencent Holdings Limited)-based peer group mobile messaging smoking cessation intervention. This study aims to assess the feasibility, acceptability, and preliminary effects of WeChat Quit Coach. We enrolled a total of 60 Chinese immigrant smokers in 2022 in New York City for a pilot randomized controlled trial (RCT) and a single-arm pilot test. The first 40 participants were randomized to either the intervention arm (WeChat Quit Coach) or the control arm (self-help print material) using 1:1 block randomization stratified by sex. WeChat Quit Coach lasted 6 weeks, featuring small peer groups moderated by a coach, daily text messages with text questions, and chat-based instant messaging support from the coach in response to peer questions. The next 20 participants were enrolled in the single-arm pilot test to further assess intervention feasibility and acceptability. All 60 participants were offered a 4-week supply of complimentary nicotine replacement therapy. Surveys were administered at baseline and 6 weeks, with participants in the pilot RCT completing an additional survey at 6 months and biochemical verification of abstinence at both follow-ups. Of 74 individuals screened, 68 (92%) were eligible and 60 (88%) were enrolled. The majority of participants, with a mean age of 42.5 (SD 13.8) years, were male (49/60, 82%) and not ready to quit, with 70% (42/60) in the precontemplation or contemplation stage at the time of enrollment. The pilot RCT had follow-up rates of 98% (39/40) at 6 weeks and 93% (37/40) at 6 months, while the single-arm test achieved 100% follow-up at 6 weeks. On average, participants responded to daily text questions for 25.1 days over the 42-day intervention period and 23% (9/40) used the chat-based instant messaging support. Most participants were satisfied with WeChat Quit Coach (36/39, 92%) and would recommend it to others (32/39, 82%). At 6 months, self-reported 7-day point prevalence abstinence rates were 25% (5/20) in the intervention arm and 15% (3/20) in the control arm, with biochemically verified abstinence rates of 25% (5/20) and 5% (1/20), respectively. WeChat Quit Coach was feasible and well-received by Chinese immigrants who smoke and produced promising effects on abstinence. Large trials are warranted to assess its efficacy in promoting abstinence in this underserved population. ClinicalTrials.gov NCT05130788; https://clinicaltrials.gov/study/NCT05130788.

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial

BackgroundCigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.ObjectiveTo investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.MethodsA prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.DiscussionAs tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial.Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.

Behavioral Activation mHealth Application for Smoking Cessation: A Randomized Controlled Pilot Trial

Abstract Introduction Behavioral activation (BA) is an effective intervention for both depression and substance use disorders. Combining BA with a standard smoking cessation intervention may improve quit rates by addressing depressive symptoms, a key barrier to quitting. This study preliminarily evaluated the acceptability and efficacy of the BA-based Actify! mobile health application (mHealth app) for smoking cessation. Aims and Methods We conducted a pilot randomized controlled trial (n = 242) comparing Actify! with the National Cancer Institute’s (NCI) app for smoking cessation (QuitGuide) on acceptability (user satisfaction, app openings), smoking abstinence, and mechanisms of change (BA and depressive symptoms) at 8 weeks and 6 months postrandomization. Participants were US adults recruited online who smoked daily. Results Treatment satisfaction was uniformly higher in the Actify! arm. Number of app openings was similar across arms (M = 34.3 openings over 8 weeks in both arms). Self-reported 30-day point prevalence abstinence (PPA) at 8 weeks was 12.6% for Actify! versus 7.3% for QuitGuide. Differences in 30-day PPA continued through 6 months (18.5% for Actify! vs. 12.2% for QuitGuide). Changes between baseline and 8 weeks in depressive symptoms and BA favored Actify!. Planned subgroup analyses suggested greater benefit of Actify! among participants with pretreatment mild-to-moderate depression symptom severity compared to those with no depression symptoms. Conclusions Actify! showed considerable promise as a novel mHealth treatment, as evidenced by its high usage and higher user satisfaction and quit rates than QuitGuide at both short- and long-term follow-up. The next step is to evaluate Actify! in a fully powered efficacy trial. Implications Study findings demonstrate the promise of a BA-based mobile health app (Actify!) for smoking cessation as a population-level intervention that can effectively address depressive symptoms as a risk factor for worse smoking treatment outcomes. The Actify! app is the first standalone BA-based app to demonstrate potential for improved acceptability and efficacy relative to a standard care comparison app, with user satisfaction and smoking quit rates descriptively exceeding those of the NCI’s QuitGuide app.

The Efficacy of the SinHumo App Combined With a Psychological Treatment to Quit Smoking: A Randomized Clinical Trial.

This study assessed the efficacy of the SinHumo App combined with a cognitive-behavioral smoking cessation treatment on 12-month follow-up abstinence, compared with the same smoking cessation treatment and a control App. A sample of 288 treatment-seeking people who smoke were randomized: SinHumo App plus smoking cessation treatment (n = 140) and control App plus smoking cessation treatment (n = 148). The primary outcome was 7-day point prevalence abstinence (PPA) at the 12-month follow-up. Secondary outcomes were abstinence rates at the end of the intervention and 3- and 6-month follow-ups, cigarette per day (CPD) reduction over the 12-month follow-up, intervention engagement, and satisfaction. Intention-to-treat analyses showed nonsignificant differences in self-reported 7-day PPA at the 12-month follow-up (37.1 and 42.6%, respectively; OR = 0.80). No significant differences were found in abstinence at the end of the treatment (68.6 vs. 62.8%) nor on 7-day PPA at 3- (35.7 vs. 45.9%) and 6-month (35.0 vs. 41.2%) follow-up. Complete case and multiple imputation analyses yielded similar results for abstinence outcomes. A significant reduction in CPD across the 12-month follow-up in the subsample of participants who smoked was observed, but nonsignificant differences between conditions were found. Higher engagement with the SinHumo App was a significant predictor of 12-month abstinence. Satisfaction with the intervention was high and similar in both groups. High abstinence rates over the 12-month follow-up and satisfaction were found in both conditions. The inclusion of the SinHumo App did not improve abstinence rates in the intervention. Scarce research has examined the long-term efficacy of smoking cessation treatments, including Apps, to support the quitting process. The present randomized controlled trial contributes to the existing literature about including information and communication technologies in behavior change interventions. The development of effective smoking cessation apps and information and communication technologies-based interventions is crucial for reducing the prevalence of smoking, as these interventions have the potential to reach a large number of people who smoke and reduce access-related barriers to treatment.

Efficacy of an individual-tailored smoking cessation intervention APP among Chinese smokers: study protocol for a randomized controlled trial

Background and aimsTobacco use has posed a tremendous public health problem for China. The Chinese government has taken great efforts to curb the tobacco epidemic. However, the existing smoking cessation services available in China are underused and have some limitations. Our research team intends to develop a smartphone smoking cessation application (SSC APP) and integrate it with the existing smoking cessation services. This study aims to assess the efficacy of the SSC APP developed by our research team through a randomized controlled trial (RCT).MethodsCurrent smokers who are motivated to quit within 1 month (n = 1000) will be recruited both online and offline, and all potential participants will register and complete the prescreening assessment online. Participants will be randomly assigned to either the intervention group (receiving the SSC APP and a self-help smoking cessation manual) or the control group (receiving a self-help smoking cessation manual only) using a block randomization method. This study will be a two-arm, single-blind, parallel-group RCT. Participants will be followed up after enrollment through online questionnaires or by phone call. The primary outcome is self-reported 6-month continuous abstinence. The main secondary outcomes include self-reported 7-day point-prevalence abstinence at each follow-up; self-reported 3-month continuous abstinence; reduction in the number of cigarettes smoked per day; and the number of recent quit attempts.DiscussionIf this SSC APP proves to be effective, it could be integrated with the existing smoking cessation services and further facilitate smoking cessation at the population level in China.Trial registrationChinese Clinical Trial Registry: ChiCTR2200062097, Registered July 22, 2022.

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial.

iCanQuit is a smartphone application (app) proven efficacious for smoking cessation in a Phase III randomized controlled trial (RCT). This study aimed to measure whether medications approved by the US Food and Drug Administration (FDA) for smoking cessation would further enhance the efficacy of iCanQuit, relative to its parent trial comparator-the National Cancer Institute's (NCI's) QuitGuide app. Secondary analysis of the entire parent trial sample of a two-group (iCanQuit and QuitGuide), stratified, doubled-blind RCT. United States. Participants who reported using an FDA-approved cessation medication on their own (n= 619) and those who reported no use of cessation medications (n= 1469). Participants were randomized to receive iCanQuit app or NCI's QuitGuide app. Use of FDA-approved medications was measured at 3 months post-randomization. Smoking cessation outcomes were measured at 3, 6 and 12 months. The primary outcome was 12-month self-reported 30-day point prevalence abstinence (PPA). The data retention rate at the 12-month follow-up was 94.0%. Participants were aged 38.5 years, 71.0% female, 36.6% minority race/ethnicity, 40.6% high school or less education, residing in all 50 US States and smoking 19.2 cigarettes/day. The 29.6% of all participants who used medications were more likely to choose nicotine replacement therapy (NRT; 78.8%) than other cessation medications (i.e. varenicline or bupropion; 18.3 and 10.5%, respectively) and use did not differ by app treatment assignment (all P> 0.05). There was a significant (P= 0.049) interaction between medication use and app treatment assignment on PPA. Specifically, 12-month quit rates were 34% for iCanQuit versus 20% for QuitGuide [odds ratio (OR) = 2.36, 95% confidence interval (CI) = 1.59, 3.49] among participants reporting any medication use, whereas among participants reporting no medication use, quit rates were 28% for iCanQuit versus 22% for QuitGuide (OR = 1.41, 95% CI = 1.09, 1.82). Results were stronger for those using only NRT: 40% quit rates for iCanQuit versus 18% quit rates for QuitGuide (OR = 3.57, 95% CI = 2.20, 5.79). The iCanQuit smartphone app for smoking cessation was more efficacious than the QuitGuide smartphone app, regardless of whether participants used medications to aid cessation. Smoking cessation medications, especially nicotine replacement therapy, might enhance the efficacy of the iCanQuit app.

Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial

As summarised in the most recent Cochrane review, the few clinical trials on e-cigarettes are largely focused on smoking cessation. We aimed to determine the naturalistic uptake, use, and impact of e-cigarettes among adults who may or may not want to stop smoking. In this naturalistic, randomised, controlled clinical trial, adult smokers, across the motivational spectrum and with minimal history of e-cigarette use, were recruited online from the general community within 11 cities across the USA. Participants were randomly assigned (2:1) to either receive either a free 4-week supply of flavoured, tank-style e-cigarette, or not. E-cigarette group participants received a battery and device with up to 30 pre-filled tanks, offered among five flavours, with minimal instructions on use. The study's primary purpose was to descriptively assess naturalistic uptake and usage of the e-cigarette, and to secondarily assess its impact on smoking behavior. The latter, assessed through six months of follow-up, included: a) self-reported 7-day point prevalence abstinence, b) incidence of quit attempts, and c) smoking reduction. This trial is registered at ClinicalTrials.gov, NCT03453385. Between 5/2018 and 3/2022, 638 adult smokers were enrolled and randomly assigned (427 in the e-cigarette group and 211 in the no-product control group). Uptake of e-cigarettes was robust: approximately 70% of participants used the product, with average usage exceeding 4 days per week during the initial 30 days. Based on an intent-to-treat approach where missing data is imputed as smoking, almost all behavioral outcomes favored the e-cigarette group relative to no-product control, including point prevalence abstinence at six months (Odds Ratio [OR]=1.8; 95% Confidence Interval [CI]=1.0-3.1), cumulative incidence of 24-hr quit attempts (OR=1.5; 95% CI=1.0-2.2), and having reduced smoking by at least 50% since baseline (OR=1.8; 95% CI=1.2-2.7). Results were similar under an alternative imputation. Complementing cessation-focused trials, results suggest that unguided e-cigarette use also leads tosmoking cessation, allaying the notion that causal effects of e-cigarettes on cessation are not reflective of real-world scenario of self-determined use. For smokers who may not be able to quit using existing pharmacologic approaches, e-cigarettes may be considered to achive that purpose. National Cancer Institute.

Is self-reported 7-day point prevalence abstinence an useful measure for smoking cessation effectiveness among individuals with mental disorders?

Smoking rates among individuals with mental disorders are higher compared to general population. We aimed to investigate the effectiveness of a smoking cessation treatment among individuals with and without mental disorders. Self-report 7-day point prevalence was used to assess abstinence status among ‘intention to treat’ (n = 1,213) and ‘completers-only’ (n = 578) samples. Participants were distributed in (1) ND-only; (2) ND and other substance use disorder (ND-SUD); (3) ND associated with mental disorder but no other SUD (ND-MD); and (4) co-morbid ND, SUD and MD (ND-SUMD). The treatment program was composed by six weeks of group Cognitive Behavioral Therapy (CBT) and medical consultations. Multivariate logistic regression models were applied. Rates of abstinence between ND-only and both ND-MD and ND-SUMD differed in the ‘intention-to-treat’ sample, with the former group showing the best rate (62.5%, 48% and 45.4% respectively). ND-SUD had the second-best rate of abstinence (56.1%). Differences between groups were not observed among ‘completers-only’. Self-report 7-day point prevalence abstinence is economical and reliable to be used in low to middle-income countries. In this study, it showed that the 6-week smoking cessation treatment had a positive effect among completers, which supports the importance of investing in treatment to decrease smoking prevalence in this population.

Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial.

Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines. This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation. This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment. Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027. The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States. ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831. PRR1-10.2196/48898.

Tobacco-Related Disease, Health Beliefs, and Post-hospital Tobacco Abstinence

Most hospitalized patients who smoke resume after discharge. Associations of tobacco-related disease and health beliefs with post-hospitalization abstinence were examined. This was a cohort study using data from a 2018-2020 multicenter trial of hospitalized adults who smoked and wanted to quit. Tobacco-related disease was defined using primary discharge diagnosis codes. Baseline health beliefs included (1) smoking caused hospitalization, (2) quitting speeds recovery, and (3) quitting prevents future illness. Outcomes included self-reported 7-day point prevalence abstinence 1, 3, and 6 months after discharge. Separate logistic regression models for each of the three health beliefs were constructed. Models stratified by tobacco-related disease explored effect modification. Analysis was performed in 2022-2023. Of 1,406 participants (mean age 52 years, 56% females, 77% non-Hispanic White), 31% had tobacco-related disease, 42% believed that smoking caused hospitalization, 68% believed that quitting speeds recovery, and 82% believed that quitting prevents future illness. Tobacco-related disease was associated with higher 1-month point prevalence abstinence in each health belief model (AOR=1.55, 95% CI=1.15, 2.10; 1.53, 95% CI=1.14, 2.05; and 1.64, 95% CI=1.24, 2.19, respectively) and higher 6-month point prevalence abstinence in models including health beliefs 2 and 3. Quitting speeds recovery was the only belief associated with higher 1-month point prevalence abstinence (AOR=1.39, 95% CI=1.05, 1.85). Among patients with tobacco-related disease, the belief that quitting prevents future illness was associated with higher 1-month point prevalence abstinence (AOR=2.00, 95% CI=1.06, 3.78). Tobacco-related disease predicts abstinence 1 and 6 months after hospitalization independent of health beliefs. Beliefs that quitting speeds recovery and prevents future illness may serve as targets for smoking-cessation interventions.

Expanding population-level interventions to help more low-income smokers quit: Study protocol for a randomized controlled trial

BackgroundLow-income Americans have higher rates of smoking and a greater burden of smoking-related disease. In the United States, smokers in every state can access evidence-based telephone counseling through free tobacco quitlines. However, quitlines target smokers who are ready to quit in the next 30 days, which can exclude many low-income smokers. A smoke-free homes intervention may help engage smokers in tobacco control services who are not yet ready to quit. Previous research in low-income populations suggests that receiving a smoke-free homes intervention is associated with higher quit rates. This study tests whether, at a population level, expanding on quitlines to include a smoke-free homes intervention for smokers not ready to quit could engage more low-income smokers and increase long-term cessation rates. MethodsIn a Hybrid Type 2 design, participants are recruited from 211 helplines in 9 states and randomly assigned to standard quitline or quitline plus smoke-free homes intervention arms. Participants in both arms are initially offered quitline services. In the quitline plus smoke-free homes condition, participants who decline the quitline are then offered a smoke-free homes intervention. Participants complete a baseline and follow-up surveys at 3 and 6 months. Those who have not yet quit at the 3-month follow-up are re-offered the interventions, which differ by study arm. The primary study outcome is self-reported 7-day point prevalence abstinence from smoking at 6-month follow-up. ConclusionThis real-world cessation trial involving 9 state tobacco quitlines will help inform whether offering smoke-free homes as an alternative intervention could engage more low-income smokers with evidence-based interventions and increase overall cessation rates.This study has been registered at ClinicalTrials.gov (Study Identifier: NCT04311983).

Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial

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.