Dataset Information

Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial.

ABSTRACT: Background:Individuals with type 2 diabetes (T2D) who smoke are at increased risk for many types of cancers as well as an accelerated progression of microvascular and macrovascular complications. Smoking cessation is recommended as a standard treatment for T2D; however, individuals with T2D are faced with competing lifestyle changes. Glycemic and blood pressure control often take precedence over smoking cessation, and patients are often unmotivated to quit. Contingency management in combination with standard smoking cessation treatment has been demonstrated to improve cessation outcomes in various populations. The purpose of this randomized controlled feasibility trial is to explore the feasibility of contingency management and biochemical verification using a remote smartphone-based carbon monoxide monitor for smoking cessation among individuals with T2D. Methods:A three-arm, randomized controlled feasibility trial will be conducted in two study sites that include the USA and UK. We will recruit 60 participants who will each receive usual care smoking cessation treatment (counseling and nicotine replacement therapy) and be randomized to a short term incentives (6?weeks), long term incentives (12?weeks), or no incentives (control) group. Participants will receive a smartphone and carbon monoxide monitor to complete daily remote assessments throughout the 12?weeks and will complete an exit interview at the end of the study. The primary outcomes for this feasibility study include completion of the protocol and proportion of daily assessments completed. Secondary outcomes include recruitment measures, acceptability, and smoking abstinence. Discussion:We will explore the feasibility of recruiting smokers with T2D and their engagement in the program, particularly related to the use of the remote biochemical verification and smartphone application. In addition, we will evaluate the intervention content, study procedures, data collection methods, and follow-up and will qualitatively assess the participants' acceptability of the program. The results of this study will inform the design of a larger trial to test the efficacy of the contingency management program for improving smoking cessation outcomes among individuals with T2D. Trial registration:This randomized controlled feasibility trial has been registered at ClinicalTrials.gov with an ID NCT03527667 on May 4, 2018.

SUBMITTER: Martinez SA

PROVIDER: S-EPMC7291555 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial.

Martinez Sydney A SA Quaife Samantha L SL Hasan Afsheen A McMillan Kathryn A KA Beebe Laura A LA Muirhead Fiona F

Pilot and feasibility studies 20200611

<h4>Background</h4>Individuals with type 2 diabetes (T2D) who smoke are at increased risk for many types of cancers as well as an accelerated progression of microvascular and macrovascular complications. Smoking cessation is recommended as a standard treatment for T2D; however, individuals with T2D are faced with competing lifestyle changes. Glycemic and blood pressure control often take precedence over smoking cessation, and patients are often unmotivated to quit. Contingency management in comb ...[more]

PMID: 32537238

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Project description:BACKGROUND:Even after quitting illicit drugs, tobacco abuse remains a major cause of morbidity and mortality in former injection drug users. An important unmet need in this population is to have effective interventions that can be used in the context of community based care. Contingency management, where a patient receives a monetary incentive for healthy behavior choices, and incorporation of individual counseling regarding spirometric "lung age" (the age of an average healthy individual with similar spirometry) have been shown to improve cessation rates in some populations. The efficacy of these interventions on improving smoking cessation rates has not been studied among current and former injection drug users. METHODS:In a randomized, factorial design study, we recruited 100 active smokers from an ongoing cohort study of current and former injection drug users to assess the impact of contingency management and spirometric lung age on smoking cessation. The primary outcome was 6-month biologically-confirmed smoking cessation comparing contingency management, spirometric lung age or both to usual care. Secondary outcomes included differences in self-reported and biologically-confirmed cessation at interim visits, number of visits attended and quit attempts, smoking rates at interim visits, and changes in Fagerstrom score and self-efficacy. RESULTS:Six-month biologically-confirmed smoking cessations rates were 4% usual care, 0% lung age, 14% contingency management and 0% for combined lung age and contingency management (p = 0.13). There were no differences in secondary endpoints comparing the four interventions or when pooling the lung age groups. Comparing contingency management to non-contingency management, 6-month cessation rates were not different (7% vs. 2%; p = 0.36), but total number of visits with exhaled carbon monoxide-confirmed abstinence were higher for contingency management than non-contingency management participants (0.38 vs. 0.06; p = 0.03), and more contingency management participants showed reduction in their Fagerstrom score from baseline to follow-up (39% vs. 18%; p = 0.03). CONCLUSIONS:While lung age appeared ineffective, contingency management was associated with more short-term abstinence and lowered nicotine addiction. Contingency management may be a useful tool in development of effective tobacco cessation strategies among current and former injection drug users. TRIAL REGISTRATION:Clinicaltrials.gov NCT01334736 (April 12, 2011).

Project description:BackgroundCigarette smoking is disproportionately high among people experiencing homelessness (PEH). Contingency management (CM) is a strategy that has shown considerable efficacy for smoking cessation and has been used in short-term studies of smoking abstinence in PEH. We describe a pilot, pragmatic randomized controlled trial protocol, which leverages an electronic health record (EHR) infrastructure to assess the feasibility and acceptability of an extended CM intervention to improve long-term abstinence in PEH.MethodsWe will conduct the study at three safety-net clinics in San Francisco among 90 adults experiencing homelessness who smoke cigarettes currently and have a desire to quit. We will encourage all participants to receive smoking cessation services that include behavioral counseling and pharmacotherapy through their clinics. We will randomly assign participants to an extended CM intervention group with escalating incentives contingent on abstinence or to a control group with fixed incentives for attending study visits. We will use the EHR to recruit participants, track receipt of counseling and pharmacotherapy during clinical care, and communicate with providers on participants' progress. CM participants will get escalating incentives for demonstration of carbon monoxide-verified abstinence over 6 months, with a total possible earnings of $475. Control participants will receive a fixed incentive of $5 for attending study visits, totaling $125. We will conduct the carbon-monoxide verified abstinence assessments-which will determine CM incentive amounts-daily during week 1, bi-weekly through week 4, weekly through week 13, and monthly through week 24. Measures of feasibility and acceptability, both quantitative and qualitative, will include assessments of screening and recruitment, adherence to study visits, engagement in smoking cessation clinical care, retention, and participant satisfaction. One of the primary clinical outcomes will be biochemically verified 7-day point prevalence abstinence at 6 months. We will measure secondary outcomes, which will include 7-day point prevalence abstinence at 2 weeks, 3 and 12 months.DiscussionThis trial will allow us to assess the feasibility and acceptability of a CM cessation intervention among PEH. The protocol's clinical setting and use of EHRs gives it significant potential for scalability. If found to be feasible, acceptable, and subsequently efficacious in a larger trial, the intervention could reduce tobacco-related health disparities by increasing long-term smoking abstinence among this vulnerable population.Trial registrationClinicalTrials.gov NCT04982952. Registered on July 29, 2021.

Project description:IntroductionContinued smoking following a cancer diagnosis has substantial health risks including increased overall and cancer-specific mortality, risk of secondary malignancies, cancer treatment toxicity and risk of surgical complications. These risks can be mitigated by quitting smoking. The preoperative period represents a prime opportunity in which to administer robust smoking cessation treatment to both improve health and support and improve surgical outcomes. We will conduct a randomised clinical trial to evaluate the effectiveness of financial incentives delivered contingent on biochemically verified smoking abstinence (contingency management (CM)) in patients with cancer undergoing surgery.Methods and analysisThe study will take place across two study sites, and participants (N=282) who smoke, are diagnosed with or suspected to have any type of operable cancer and have a surgical procedure scheduled in the next 10 days to 5 weeks will be randomised to receive standard care plus Monitoring Only or CM prior to surgery. All patients will receive breath carbon monoxide (CO) tests three times per week, nicotine replacement therapy and counselling. The CM group will also earn payments for self-reported smoking abstinence confirmed by CO breath test ≤4 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Point prevalence abstinence (PPA) outcomes (self-report of 7-day abstinence confirmed by CO≤4 ppm and/or anabasine ≤2 ng/mL) will be assessed on the day of surgery and 6 months after surgery. The effect of CM on 7-day PPA at the time of surgery and 6-month follow-up will be modelled using generalised linear mixed effects models.Ethics and disseminationThis study has been reviewed and approved by the Medical University of South Carolina Institutional Review Board. We will disseminate our scientific results through traditional research-oriented outlets such as presentations at scientific meetings and publications in peer-reviewed journals.Trial registration numberNCT04605458.

Project description:BackgroundSmoking among sexual and gender minority (SGM) groups, which include lesbian, gay, bisexual, transgender, and queer individuals, has been reported to be highly prevalent. This is attributed to several factors, including minority-specific stress and targeted tobacco marketing. Therefore, this population is at an increased risk for tobacco-related diseases. SMS text messaging programs have been found to be effective for smoking cessation and appeal to traditionally hard-to-reach populations over other interventions. It has also been suggested that targeted and tailored interventions could be more effective among SGM smokers because they can be designed to assure a safe, validating health care environment that enhances receptivity to cessation.ObjectiveThe aim of this study is to develop SmokefreeSGM, a text-based smoking cessation program tailored to and tested among SGM smokers.MethodsThe study consists of three phases, culminating in a feasibility trial. In Phase 1, our research team will collaborate with a Community Advisory Board to develop and pretest the design of SmokefreeSGM. In Phase 2, the tailored text messaging program will be beta tested among 16 SGM smokers. Our research team will use a mixed-methods approach to collect and analyze data from participants who will inform the refinement of SmokefreeSGM. In Phase 3, a feasibility trial will be conducted among 80 SGM smokers either enrolled in SmokefreeSGM or SmokefreeTXT, the original text-based program developed by the National Cancer Institute for the general population. Our research team will examine recruitment, retention, and smoking abstinence rates at 1-, 3-, and 6-month follow-up. Additionally, a qualitative interview will be conducted among 32 participants to evaluate the feasibility and acceptability of the programs (SmokefreeSGM and SmokefreeTXT).ResultsThis study received approval from The University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects to begin research on August 21, 2020. Recruitment for the beta testing of SmokefreeSGM (Phase 2) began in January 2022. We estimate that the feasibility trial (Phase 3) will begin in September 2022 and that results will be available in December 2023.ConclusionsFindings from this research effort will help reduce tobacco-related health disparities among SGM smokers by determining the feasibility and acceptability of SmokefreeSGM, an SGM-tailored smoking cessation intervention.Trial registrationClinicalTrials.gov NCT05029362; https://clinicaltrials.gov/ct2/show/NCT05029362.International registered report identifier (irrid)DERR1-10.2196/42553.

Dataset Information

Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial.

Publications

Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial.

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