scholarly journals A Pilot Randomized Controlled Trial of Smoking Cessation in an Outpatient Respirology Clinic

2015 ◽  
Vol 22 (2) ◽  
pp. 91-96 ◽  
Author(s):  
Smita Pakhale ◽  
Justine Baron ◽  
Michael A Armstrong ◽  
Avanti Garde ◽  
Robert D Reid ◽  
...  

OBJECTIVE: To assess the feasibility and potential effectiveness of a modified version of the Ottawa Model for Smoking Cessation in an outpatient respirology clinic.METHODS: Adult tobacco smokers attending the respirology clinic and willing to choose a quit date within one month of enrollment were randomly assigned to receive standard care or the intervention. Standard care participants received smoking cessation advice, a brochure and a prescription for smoking cessation medication if requested. Intervention participants received a $110 voucher to purchase smoking cessation pharmacotherapy and were registered to an automated calling system. Answers to automated calls determined which participants required nurse telephone counselling. Feasibility indicators included recruitment and retention rates, and intervention adherence. The effectiveness indicator was self-reported smoking status at 26 to 52 weeks.RESULTS: Forty-nine (54.4%) of 90 eligible smokers were randomly assigned to the intervention (n=23) or control (n=26) group. Self-reported smoking status at 26 to 52 weeks was available for 32 (65.3%) participants. The quit rate for intervention participants was 18.2% compared with 7.7% for controls (OR2.36 [95% CI 0.39 to 14.15]).CONCLUSION: It would be feasible to evaluate this intervention in a larger trial. Alternatives to face-to-face follow-up at the clinic are recommended.

2018 ◽  
Author(s):  
Laurie Zawertailo ◽  
Tara Mansoursadeghi-Gilan ◽  
Helena Zhang ◽  
Sarwar Hussain ◽  
Bernard Le Foll ◽  
...  

BACKGROUND Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. OBJECTIVE The primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation. METHODS This is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales. RESULTS The project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway. CONCLUSIONS To the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials. CLINICALTRIAL ClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ) REGISTERED REPORT IDENTIFIER RR1-10.2196/10826


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jaqueline Scholz ◽  
Tania O Abe ◽  
Patricia Gaya ◽  
Iana R Moraes ◽  
Bianca Bellini ◽  
...  

Introduction: Varenicline effectively helps smokers quit by reducing withdrawal symptoms and blocking the reward of smoking. However, most quitters return to smoking within 1 year. “Cue-restricted smoking” is a behavioral technique designed to increase quit rates by asking smokers attempting to quit to restrict smoking to the standing position, while alone, in an isolated area facing a wall, with the cigarette as the only stimulus. Hypothesis: We compared the effectiveness of cue-restricted smoking cessation advice versus standard target quit date advice from day 8 of initiating varenicline in smokers making a quit attempt at the Smoking Cessation Service at the Prevention Department of the Heart Institute, Sao Paulo, Brazil. Methods: Using retrospective clinic records we compared quit rates in 281 smokers (50% males) instructed in the cue-restricted smoking cessation method during 2016-18 to quit rates in 324 smokers (46% males) advised to completely stop smoking on the target quit date which we previously used during 2011-14. All were prescribed varenicline for 12 weeks alone, with the addition of bupropion if needed after 4 weeks. Follow-up consisted of behavioral support at 4-6 visits during active drug treatment and telephone counselling at 24 and 52 weeks. The smoking cessation rate was confirmed with expired carbon monoxide at the 12-week clinic visit and only by telephone at 52 weeks. Results: The mean age of smokers was 49 ±12 years both groups and the number of cigarettes smoked daily was similar (18/day in the cue-restricted versus 19/day in the target quit day group). The smoking cessation rate at 12 weeks was 75% in the cue-restricted versus 45% in the target quit day group (relative risk 1.8; 95% confidence interval 1.4-2.2; p<0.001). At 52 weeks the quit rate was 65% vs 34% respectively (relative risk 1.9; 95% confidence interval 1.5-2.4; p<0.001). Conclusion: Cue restricted smoking substantially increased the chance of quitting compared with standard advice during treatment with varenicline . These results should be further studied in a randomized controlled trial.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Mégane Héron ◽  
Anne-Laurence Le Faou ◽  
Gladys Ibanez ◽  
Brigitte Métadieu ◽  
Maria Melchior ◽  
...  

Abstract Background Compared to smokers with favorable socio-economic position (SEP), those with low SEP are less likely to have a successful smoking cessation attempt. Tailored approaches are therefore needed, and general practitioners could help reaching and assisting usually hard-to-reach population. Method STOP (Sevrage Tabagique à l’aide d’Outils dédiés selon la Préférence) is a pilot study, examining the feasibility, acceptability and potentiality of a smoking cessation intervention centered on smoker’s preference. Smokers with low SEP, wishing to quit, were recruited in six healthcare centers in the Greater Paris area. They were asked to choose between different types of nicotine replacement therapy (NRT) products and/or e-cigarette with liquids delivered free of charge to aid their smoking cessation attempt. We describe the characteristics of recruited participants, their perception of smoking cessation aids, and the evolution of their smoking status 4 to 6 weeks after recruitment. Results We recruited 49 participants, of which 29% chose an e-cigarette, 29% chose NRT and 42% chose both an e-cigarette and NRT. The intervention was shown to be acceptable by participants and health professionals. Among the 24 participants followed for at least one month, 14 (28% of all participants) stopped smoking, and 9 (18%) considerably reduced their consumption. Conclusion The STOP intervention is feasible and acceptable, even if more efforts should be made to limit lost-to-follow-up. This preference-based intervention also shows interesting prospect in helping smokers with low SEP quit smoking. We will test the efficacy of this preference-based intervention in a randomized controlled trial.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Yim Wah Mak ◽  
Doris Y. P. Leung ◽  
Alice Yuen Loke

Abstract Background The aim of this study was to examine the effectiveness of delivering an individual Acceptance and Commitment Therapy (ACT) for smoking cessation among a Chinese population. Methods Participants were recruited from six primary health care centers. A total of 144 were eligible to take part in the study and agreed to be randomized to the intervention (ACT) group (n = 70) and control group (n = 74), respectively. Both groups received self-help materials on smoking cessation. The ACT group also underwent an initial face-to-face session and two telephone ACT sessions at 1 week and 1 month following the first session. They were re-contacted through telephone follow-ups at 3, 6, and 12 months by research assistants. The primary outcome was self-reported 7-day point-prevalence abstinence at the 12-month follow-up session. Other outcomes included biochemically validated quitting, quitting attempts, the intention to quit, the self-perception of quitting, and psychological flexibility. Results There was no significant difference in the self-reported 7-day point prevalence quit rate at the 12-month follow-up between the intervention group (24.3%) and the control group (21.6%) (risk ratio = 1.12; 95%CI = (0.62, 2.05); p = 0.704). Greater improvements in secondary outcomes from baseline to the 12-month follow-up were observed in the ACT group than in the control group, including a forward progression in the participants’ readiness to quit smoking (p = 0.014) and increased psychological flexibility (p = 0.022). Conclusions This study is the first evidence of a randomized-controlled trial on the adoption of an individual ACT for smoking cessation, delivered initially in primary health care settings and subsequently by telephone within a Chinese population. The present study found that the brief ACT intervention could not produce a significant quit rate but was promising in terms of bringing about cognitive changes, including greater psychological flexibility, and more confidence about quitting, when compared to the use of self-help materials only among the general population. Trial registration This trial was registered prospectively with the U.S. National Library of Medicine: (NCT01652508) on 26th July 2012.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Coja ◽  
K A Mullen ◽  
A L Pipe ◽  
R D Reid

Abstract Background/Introduction Tobacco use is a major risk factor for the leading chronic diseases, is a leading cause of preventable death worldwide, and is a large cost driver of healthcare spending. Quitting smoking is the single most effective thing a patient can do to improve their health. The Ottawa Model for Smoking Cessation (OMSC) is a systematic, comprehensive approach to clinical tobacco dependence treatment. It provides support to healthcare settings in establishing a high quality tobacco treatment protocol and addressing common barriers to ensure optimal delivery of evidence-based smoking cessation interventions. Purpose The OMSC assists healthcare professionals to transform clinical practices through knowledge translation, implementation support, and quality evaluation. It promotes the delivery of evidence-based interventions to a greater number of smokers using a systematic approach, ultimately increasing cessation rates. The OMSC assists providers to identify smoking status, provide strategic advice to quit, support patients in making a quit attempt, and provide follow-up support. Methods OMSC Outreach Facilitators work with healthcare setting to assist with implementing evidence-based smoking cessation interventions. This is guided by an OMSC workplan which covers planning, implementing, evaluating and sustainability. Pre and post implementation along with program-level data is collected and used to determine rates of smoking status documentation, brief advice to stop smoking, delivery of cessation support and patient quit rates. Results The OMSC program has worked with approximately 450 healthcare settings, trained over 20,000 healthcare professionals, and supported approximately 500,000 patients with quitting smoking. Of those not ready to quit, 45% of patients seen in primary care were supported in reducing the amount they smoke. For OMSC hospital and specialty care patients receiving follow-up support, the six month responder-quit rate was 48%. For OMSC primary care patients, the two month responder-quit rate was 57%. Patients who had previously been supported by their OMSC primary care practice but had not presented to their provider in at least 6 months were contacted to assess their smoking status. Of those reached, 44% were smoke-free. Of those who relapsed, 53% indicated they would be willing to make another quit attempt, 37% of which went back to their healthcare provider to try again. Conclusion The OMSC has shown to be a simple, systematic step-by-step approach to addressing tobacco use in healthcare settings. It provides a way to create clinical efficiencies while increasing the rates at which evidence-based smoking cessation interventions are being delivered to patients, which leads to more patients making further quit attempts. The OMSC continues to expand across Canada and internationally in hopes of creating a wider smoking cessation network to support more patients with quitting smoking. Acknowledgement/Funding Ontario Ministry of Health and Long-Term Care


2020 ◽  
Author(s):  
Elizabeth L Seaman ◽  
Cendrine D Robinson ◽  
David Crane ◽  
Jennifer M Taber ◽  
Rebecca A Ferrer ◽  
...  

BACKGROUND Most smokers attempt to stop using cigarettes numerous times before successfully quitting. Cigarette cravings may undermine perceived competence to quit and thus constitute psychological threats to the individual’s self-concept. Self-affirmation may promote smoking cessation by offsetting these threats. OBJECTIVE This study examines whether self-affirmation is associated with smoking cessation in the context of a cessation app. Two types of self-affirmation are examined: tendency to spontaneously self-affirm, and self-affirmation inductions added to a publicly available smoking cessation app (Smoke-Free Quit Smoking Now). In addition, this study explores whether optimism and emotional states (happiness, anger, anxiousness, hopefulness, sadness) predict smoking cessation. METHODS All users who met the inclusion criteria, provided consent to participate, and completed a baseline assessment, including all individual difference measures, were randomized to 1 of 4 conditions. Half of the participants were randomly assigned to complete a self-affirmation induction upon study entry. Orthogonally, half of the participants were randomly assigned to receive self-affirming text notifications during their quit attempt or to receive conventional notifications. The induction and the text notifications were fully automated, and all data were collected through self-assessments in the app. Self-reported smoking cessation was assessed 1 month and 3 months following study entry. RESULTS The study enrolled 7899 participants; 647 completed the 1-month follow-up. Using an intent-to-treat analysis at the 1-month follow-up, 7.2% (569/7899) of participants self-reported not smoking in the previous week and 6.4% (503/7899) self-reported not smoking in the previous month. Greater tendency to spontaneously self-affirm predicted a greater likelihood of cessation (<i>P</i>&lt;.001) at 1 month after controlling for smoking-related variables. Neither self-affirmation induction influenced cessation. In addition, spontaneous self-affirmation did not moderate the relationship between self-affirmation inductions and cessation. Greater baseline sadness was associated with a lower likelihood of reporting successful cessation. Optimism predicted past-week cessation at the 1-month follow-up, and both happiness and anger predicted past-month cessation at the 1-month follow-up; however, none of these potential predictors moderated the relationship between self-affirmation conditions and successful cessation. CONCLUSIONS Spontaneous self-affirmation may be an important psychological resource for managing threats to self-concept during the smoking cessation process. Sadness may hinder quit attempts. Future research can explicate how spontaneous versus induced self-affirmation can promote smoking cessation and examine boundary conditions for the effectiveness of disseminated self-affirmation interventions. CLINICALTRIAL ISRCTN Registry 56646695; https://www.isrctn.com/ISRCTN56646695


10.2196/23989 ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. e23989
Author(s):  
Sebastian Linnemayr ◽  
Rushil Zutshi ◽  
William Shadel ◽  
Eric Pedersen ◽  
Maria DeYoreo ◽  
...  

Background Smoking rates are significantly higher among young people experiencing homelessness than in the general population. Despite a willingness to quit, homeless youth have little success in doing so on their own, and existing cessation resources tailored to this population are lacking. Homeless youth generally enjoy the camaraderie and peer support that group-based programs offer, but continuous in-person support during a quit attempt can be prohibitively expensive. Objective This study aimed to assess the feasibility and acceptability of an automated text messaging intervention (TMI) as an adjunct to group-based cessation counseling and provision of nicotine patches to help homeless youth quit smoking. This paper outlines the lessons learned from the implementation of the TMI intervention. Methods Homeless youth smokers aged 18 to 25 years who were interested in quitting (n=77) were recruited from drop-in centers serving homeless youth in the Los Angeles area. In this pilot randomized controlled trial, all participants received a group-based cessation counseling session and nicotine patches, with 52% (40/77) randomly assigned to receive 6 weeks of text messages to provide additional support for their quit attempt. Participants received text messages on their own phone rather than receiving a study-issued phone for the TMI. We analyzed baseline and follow-up survey data as well as back-end data from the messaging platform to gauge the acceptability and feasibility of the TMI among the 40 participants who received it. Results Participants had widespread (smart)phone ownership—16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages. Participants experienced interruptions in their phone use (eg, 44% [16/36] changed phone numbers during the follow-up period) but reported being able to receive the majority of messages. These survey results were corroborated by back-end data (from the program used to administer the TMI) showing a message delivery rate of about 95%. Participant feedback points to the importance of carefully crafting text messages, which led to high (typically above 70%) approval of most text messaging components of the intervention. Qualitative feedback indicated that participants enjoyed the group counseling session that preceded the TMI and suggested including more such group elements into the intervention. Conclusions The TMI was well accepted and feasible to support smoking cessation among homeless youth. Given high rates of smartphone ownership, the next generation of phone-based smoking cessation interventions for this population should consider using approaches beyond text messages and focus on finding ways to develop effective approaches to include group interaction using remote implementation. Given overall resource constraints and in particular the exigencies of the currently ongoing COVID-19 epidemic, phone-based interventions are a promising approach to support homeless youth, a population urgently in need of effective smoking cessation interventions. Trial Registration ClinicalTrials.gov NCT03874585; https://clinicaltrials.gov/ct2/show/NCT03874585 International Registered Report Identifier (IRRID) RR2-10.1186/s13722-020-00187-6


2018 ◽  
Author(s):  
Paul Krebs ◽  
Jack Burkhalter ◽  
Jeffrey Fiske ◽  
Herbert Snow ◽  
Elizabeth Schofield ◽  
...  

BACKGROUND Although smoking cessation apps have become popular, few have been tested in randomized clinical trials or undergone formative evaluation with target users. OBJECTIVE We developed a cessation app targeting tobacco-dependent cancer patients. Game design and behavioral rehearsal principles were incorporated to help smokers identify, model, and practice coping strategies to avoid relapse to smoking. In this randomized pilot trial, we examined feasibility (recruitment and retention rates), acceptability (patient satisfaction), quitting self-confidence, and other cessation-related indices to guide the development of a larger trial. METHODS We randomized 42 English-speaking cancer patients scheduled for surgical treatment to either the Standard Care (SC; telecounseling and cessation pharmacotherapies) or the experimental QuitIT study arm (SC and QuitIT game). Gameplay parameters were captured in-game; satisfaction with the game was assessed at 1-month follow-up. We report study screening, exclusion, and refusal reasons; compare refusal and attrition by key demographic and clinical variables; and report tobacco-related outcomes. RESULTS Follow-up data were collected from 65% (13/20) patients in the QuitIT and 61% (11/18) in SC arms. Study enrollees were 71% (27/38) females, 92% (35/38) white people, and 95% (36/38) non-Hispanic people. Most had either lung (12/38, 32%) or gastrointestinal (9/38, 24%) cancer. Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05). Of 20 patients in the QuitIT arm, 40% (8/20) played the game (system data). There were no differences between those who played and did not play by demographic, clinical, technology use, and tobacco-related variables. Users completed an average of 2.5 (SD 4.0) episodes out of 10. A nonsignificant trend was found for increased confidence to quit in the QuitIT arm (d=0.25, 95% CI −0.56 to 1.06), and more participants were abstinent in the QuitIT group than in the SC arm (4/13, 30%, vs 2/11, 18%). Satisfaction with gameplay was largely positive, with most respondents enjoying use, relating to the characters, and endorsing that gameplay helped them cope with actual smoking urges. CONCLUSIONS Recruitment and retention difficulties suggest that the perihospitalization period may be a less than ideal time for delivering a smoking cessation app intervention. Framing of the app as a “game” may have decreased receptivity as participants may have been preoccupied with hospitalization demands and illness concerns. Less tablet experience and older age were associated with participant dropout. Although satisfaction with the gameplay was high, 60% (12/20) of QuitIT participants did not play the game. Paying more attention to patient engagement, changing the intervention delivery period, providing additional reward and support for use, and improving cessation app training may bolster feasibility for a larger trial. CLINICALTRIAL ClinicalTrials.gov NCT01915836; https://clinicaltrials.gov/ct2/show/NCT01915836 (Archived by WebCite at http://www.webcitation.org/73vGsjG0Y)


Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.


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