Dataset Information

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. METHODS:This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask-Advise-Refer; (2) a digital (WEB?+?TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB?+?TXT?+?TTS). DISCUSSION:The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital alone, but that it may not be as cost-effective or feasible for LCS programs to implement. This study is innovative in its use of interoperable, digital technologies to deliver a sustainable, scalable, high-impact cessation intervention and to facilitate its integration within clinical practice. It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03084835 . Registered on 9 March 2017.

SUBMITTER: Graham AL

PROVIDER: S-EPMC5704639 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

Graham Amanda L AL Burke Michael V MV Jacobs Megan A MA Cha Sarah S Croghan Ivana T IT Schroeder Darrell R DR Moriarty James P JP Borah Bijan J BJ Rasmussen Donna F DF Brookover M Jody MJ Suesse Dale B DB Midthun David E DE Hays J Taylor JT

Trials 20171128 1

<h4>Background</h4>Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible ...[more]

PMID: 29179734

Similar Datasets

Project description:BackgroundHeavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested.ObjectiveThis pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component.MethodsParticipants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months.ResultsParticipants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01).ConclusionsThis is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work.Trial registrationClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.

Project description:BackgroundBlack smokers have greater difficulty in quitting and higher rates of smoking-related diseases and disabilities than the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (eg, racial discrimination) that engender increased exposure to interoceptive stress symptoms (eg, anxiety), which can ultimately lead to smoking as a means of immediate emotion regulation.ObjectiveThis study aimed to culturally adapt and initially test a novel mobile intervention (ie, Mobile Anxiety Sensitivity Program for Smoking [MASP]) that targets anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers. The MASP intervention is culturally informed to address interoceptive stress management difficulties among Black smokers and is thus hypothesized to facilitate smoking cessation.MethodsIn phase 1, a total of 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following the completion of phase 1, we will further refine the MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In phase 2, a total of 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either the smartphone-based National Cancer Institute QuitGuide app for standard mobile smoking cessation treatment or the MASP intervention. All participants in phases 1 and 2 will be enrolled remotely and will complete a web-based study screener; smartphone-based baseline assessment; daily smartphone-based ecological momentary assessments for 6 weeks; phone-based end-of-treatment qualitative interviews; and smartphone-based follow-up assessments at postbaseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (weeks 28 and 54 follow-ups will be completed by phase 2 participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphones.ResultsThis project was funded in September 2020. Phase 1 data collection began in January 2022. Phase 2 data collection is scheduled to begin in July 2022.ConclusionsIf successful, data from this study will support culturally informed treatment approaches for Black smokers and, pending findings of efficacy, provide an evidence-based mobile intervention for smoking cessation that is ready for dissemination and implementation.Trial registrationClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236.International registered report identifier (irrid)DERR1-10.2196/38905.

Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

Project description:IntroductionYoung smokers always partake in both smoking and drinking. However, drinking undermines their likelihood to attempt quitting smoking or to successfully abstain from smoking. Hence, this trial will examine the feasibility of implementing an integrated smoking cessation and alcohol intervention in young Hong Kong Chinese people. Effect sizes of the integrated intervention (II) on self-reported and biochemically validated quit rates will also be calculated.MethodsThe study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with alcohol drinking. Participants will be randomized into a standard treatment (ST), II, or control arm. The ST group will receive a brief smoking cessation intervention based on the 5A (Ask, Assess, Advice, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) models. The II group will receive brief advice on alcohol use based on the FRAMES (Feedback, Responsibility, Advice, Menu, Empathy, Efficacy) model in addition to the brief smoking cessation intervention. Both the ST and II groups will receive booster interventions at 1-week, 1-month, 3-month, and 6-month follow-up. The control group will receive leaflets on smoking cessation and alcohol reduction. Self-reported quitters at 6-month follow-up will be invited for biochemical validation. The primary outcomes are feasibility measures. The secondary outcomes are effect size of II on self-reported and biochemically validated quit rates at 6 months relative to control and ST. Outcomes will be assessed at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups.AnalysisDescriptive statistics will be used to calculate the feasibility measures. The three arms will be compared using analysis of variance for continuous variables and chi-square test for categorical variables. Effect sizes of II for self-reported and biochemically validated quit rates at 6 months will be determined using the generalized estimating equation model.

Project description:BackgroundTobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.ObjectiveOur objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation.MethodsA 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.ResultsA total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.ConclusionsThe Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.

Project description:BackgroundLung cancer mortality is reduced via low-dose computed tomography screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the National Cancer Institute's Smoking Cessation at Lung Examination collaboration.MethodsEligible patients (n = 818) aged 50-80 years were randomly assigned (May 2017-January 2021) to the intensive vs minimal arms (8 vs 3 phone sessions plus 8 vs 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed at 3, 6, and 12 months post random assignment. Logistic regression analyses evaluated the effects of study arm. All statistical tests were 2-sided.ResultsParticipants reported 48.0 (SD = 17.2) pack-years, and 51.6% were not ready to quit in less than 30 days. Self-reported 3-month quit rates were statistically significantly higher in the intensive vs minimal arm (14.3% vs 7.9%; odds ratio [OR] = 2.00, 95% confidence interval [CI] = 1.26 to 3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs 3.9%; OR = 2.70, 95% CI = 1.44 to 5.08). Compared with the minimal arm, the intensive arm was more effective among those with greater nicotine dependence (OR = 3.47, 95% CI = 1.55 to 7.76), normal screening results (OR = 2.58, 95% CI = 1.32 to 5.03), high engagement in counseling (OR = 3.03, 95% CI = 1.50 to 6.14), and patch use (OR = 2.81, 95% CI = 1.39 to 5.68). Abstinence rates did not differ statistically significantly between arms at 6 months (OR = 1.2, 95% CI = 0.68 to 2.11) or 12 months (OR = 1.4, 95% CI = 0.82 to 2.42).ConclusionsDelivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.

Dataset Information

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

Publications

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets