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Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial.

ABSTRACT: Despite smoking cessation can largely improve cancer prognosis and quality of life, many patients continued smoking after the diagnosis of cancer. This study aims to test the effectiveness of a smoking cessation intervention using risk communication approach to help cancer patients quit smoking, and to improve their health related quality of life.A cluster randomized controlled trial will be employed. Cancer patients who continued smoking after the diagnosis of cancer and have medical follow-up at the out-patient clinics of the five acute hospitals in Hong Kong will be invited to participate. Subjects in the experimental group will receive (1) health warnings of smoking based on a special designed leaflet; and (2) a patient-centred counseling from nurse counselors with emphasis on risk perceptions of smoking to cancer prognosis. Additionally, they will receive two more telephone counseling at 1-week and 1-month. Control group receive standard care and a generic self-help smoking cessation booklet. Outcomes measure include (a) self-reported and the biochemically validated quit rate, (b) patient's smoking reduction by at least 50% compared to baseline, (c) quit attempt(s), (d) change in the intention to quit, (e) change in risk perceptions of smoking, and (f) change in health related quality of life.This study will make an important contribution to evidence-based practice by testing the effectiveness of a tailored smoking cessation intervention for cancer patients. The results will support the development of clinical practice guidelines to promote smoking cessation in cancer patients to improve their prognosis and quality of life.ClinicalTrials.gov NCT01685723. Registered 9 November 2012.

SUBMITTER: Li WH

PROVIDER: S-EPMC4486692 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial.

Li William H C WH Chan Sophia S C SS Wang Kelvin M P KM Lam T H TH

BMC cancer 20150630

<h4>Background</h4>Despite smoking cessation can largely improve cancer prognosis and quality of life, many patients continued smoking after the diagnosis of cancer. This study aims to test the effectiveness of a smoking cessation intervention using risk communication approach to help cancer patients quit smoking, and to improve their health related quality of life.<h4>Methods</h4>A cluster randomized controlled trial will be employed. Cancer patients who continued smoking after the diagnosis of ...[more]

PMID: 26122078

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Project description:BackgroundDespite evidence showing that continued smoking in patients with non-communicable diseases can reduce treatment efficacy and increase the risk of disease progression and multimorbidity, many smoker patients either have no intention to quit or have had failed attempts at quitting.ObjectiveTo examine the feasibility of a general health promotion approach that uses instant messaging to deliver brief motivational interviewing to help smokers with non-communicable diseases quit smoking.MethodsIn total, 60 participants who had medical follow-up in a special out-patient clinic were randomized into two groups, 30 in the intervention group received brief motivational interviewing to assist them with their chosen behavioral changes, and 30 in the control group received only a smoking cessation booklet. The outcome measures included self-reported 7-day point prevalence of smoking abstinence and any behavioral change reported by the participants at 6 and 12 months. Biochemical validation was performed for those who verbally reported a 7-day point prevalence of smoking abstinence at 12 months.ResultsThe majority (95%) of smokers who attended the out-patient clinic owned a smartphone. The response rate was 73.2%. Retention rates at 6-month and 12-month follow-up were 83.3 and 71.7%, respectively. The process evaluation indicated that participants were satisfied with the content of the brief MI messages and appreciated the use of instant messaging as a way to provide them with professional advice and support for managing their health-related lifestyles. The intervention group had a higher biochemically validated abstinence rate than the control group at 12 months (16.7 vs. 6.7 P = 0.23) although the difference was not statistically significant (Adjusted odd ratio 2.4, 95% confidence interval, 0.43-13.75; P = 0.32.), In addition, the proportion of participants reporting a behavioral change was higher in the intervention group at 6 and 12 months.ConclusionThis study suggested the potential efficacy and feasibility of a general health promotion approach that uses instant messaging to deliver brief motivational interviewing to help smokers with non-communicable diseases quit smoking. The findings can be used to create a new smoking cessation service model that implements a flexible, proactive and personalized approach to help smokers quit smoking.Clinical trial registrationClinicalTrials.gov, identifier: NCT03983330.

Project description:BackgroundSmoking cessation is the most common preventative for an array of diseases, including lung cancer and chronic obstructive pulmonary disease. Although there are many efforts advocating for smoking cessation, smoking is still highly prevalent. For instance, in the USA in 2015, 50% of all smokers attempted to quit smoking, and only 5-7% of them succeeded - with slight deviation depending on external assistance. Previous studies show that computer-tailored messages which support smoking abstinence are effective. The combination of health recommender systems and behavioral-change theories is becoming increasingly popular in computer-tailoring. The objective of this study is to evaluate patients's smoking cessation rates by means of two randomized controlled trials using computer-tailored motivational messages. A group of 100 patients will be recruited in medical centers in Taiwan (50 patients in the intervention group, and 50 patients in the control group), and a group of 1000 patients will be recruited on-line (500 patients in the intervention group, and 500 patients in the control group). The collected data will be made available to the public in an open-source data portal.MethodsOur study will gather data from two sources. The first source is a clinical pilot in which a group of patients from two Taiwanese medical centers will be randomly assigned to either an intervention or a control group. The intervention group will be provided with a mobile app that sends motivational messages selected by a recommender system that takes the user profile (including gender, age, motivations, and social context) and similar users' opinions. For 6 months, the patients' smoking activity will be followed up, and confirmed as "smoke-free" by using a test that measures expired carbon monoxide and urinary cotinine levels. The second source will be a public pilot in which Internet users wanting to quit smoking will be able to download the same mobile app as used in the clinical pilot. They will be randomly assigned to a control group that receives basic motivational messages or to an intervention group, that receives personalized messages by the recommender system. For 6 months, patients in the public pilot will be assessed periodically with self-reported questionnaires.DiscussionThis study will be the first to use the I-Change behavioral-change model in combination with a health recommender system and will, therefore, provide relevant insights into computer-tailoring for smoking cessation. If our hypothesis is validated, clinical practice for smoking cessation would benefit from the use of our mobile solution.Trial registrationClinicalTrials.gov, ID: NCT03108651 . Registered on 11 April 2017.

Project description:Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group).The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates) and patient participation (proportion referred who go to the website). We will then compare the effectiveness of the standard and augmented patient websites.Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login) and patient outcomes (six-month smoking cessation).Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO) - a randomized controlled trial: NCT00797628.

Project description:BackgroundAutomatic processes to approach smoking-related cues have been repeatedly linked to smoking status, intensity of smoking, and cigarette craving. Moreover, recent findings suggest that targeting those tendencies directly by means of approach bias modification (ABM) has merit in changing maladaptive approach tendencies for drug cues and reducing drug consumption. However, training effects tend to be small. Embedding the training into virtual reality (VR) technology could be a promising way to improve training efficacy. The present protocol describes a randomized controlled trial that aims to assess the efficacy of a newly developed VR-ABM as a means of reducing smoking-related approach biases or nicotine consumption in smokers seeking abstinence.MethodsOne hundred daily smokers who are motivated to quit smoking will be recruited into the randomized controlled trial. All participants will attend a brief smoking cessation intervention (TAU) and will be randomly assigned either to the experimental (VR-avoidance training) or the placebo-control group (VR-placebo training). During the VR-avoidance training, participants are implicitly instructed to make an avoidance movement in response to smoking-related objects (e.g., cigarettes) and an approach movement in response to alternative objects (e.g., healthy food). During the VR-placebo training, no such contingency between arm movement and item content exists. Trainings are administered in six sessions within two weeks. Training effects on automatic approach tendencies and smoking behavior are measured immediately after training and at a 7-week follow-up.DiscussionEmbedding the training into virtual reality (VR) technology could be a promising new way to improve ecological validity, realism, and immersion and thereby increase ABM training effects. The results of this study can inform future research in the optimization and advancement of treatment for addiction.Trial registrationRegistered with Current Controlled Trials: study ID ISRCTN16006023. Registered on 28 March 2019.

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.

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Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial.

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Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial.

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