New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial

Registry record from ClinicalTrials.gov (NCT07900724). This is a study registration, not published results. Lead sponsor: Helse Nord-Trøndelag HF. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 620 participants (ESTIMATED). Conditions: Smoking Cessation, Smoking Cessation Counselling. Interventions: BEHAVIORAL: WillQuit App; BEHAVIORAL: Smoking cessation standard treatment,. Primary outcome measures: Rate of smoking cessation , From enrollment to 1 year after.. Brief summary: Cigarette smoking remains the leading modifiable risk factor for lung cancer4 and 16 other types of cancer, as well as chronic cardiovascular and pulmonary diseases. Despite public health efforts, smoking prevalence remains a major national as well as international challenge. Currently in Norway 16% of those 25-74 years of age are still daily or occasional smokers (9% and 7%, respectively), projecting a 10% of smoking prevalence during the current decade. In Europe it was estimated to be more than 183 millions current and former smokers (42% of the population) in 2017. Thus, smoking is a central public health issue nationally and internationally. Smoking cessation not only significantly reduces lung cancer risk and other smoking related diseases, but also improves life expectancy, making this intervention a critical component of primary cancer prevention. Despite a decline in smoking rates, approximately 10% of Norwegians still smoke, with non-daily smoking on the rise among young people (16-24 years), affecting 19% of men and 13% of women. This underscores the urgent need for more effective cessation strategies. A number of smoking cessation treatments have been developed, but the majority of people relapse within the first year of cessation. Primary care faces significant barriers in delivering effective smoking cessation interventions. On the clinician side, challenges include a lack of personalized treatment options, time constraints, and unclear guidelines. From the patient perspective, there is often a lack of motivation and a perception that treatments are not tailored to individual needs. This project aims to evaluate the effectiveness of a newly developed, personalized smoking cessation app designed to assists GPs in providing tailored smoking cessation treatments. Specifically, we will test whether the use of this app results in improved smoking cessation outcomes and enhanced quality of life for smokers in primary healthcare settings, compared to the current standard smoking cessation treatments. Based on the results from the app, GPs will receive advice on how to motivate this particular person to quit smoking. The point of the app is that healthcare professionals will be able to provide a more personalized smoking cessation treatment based on the information that the smoker has entered into the app compared to current practice. Our hypothesis is that by using our newly developed app, healthcare professionals will be able to achieve better smoking cessation results compared to the standard smoking cessation approach used today. The project is a clinical randomized-controlled phase 3 study in which we, through GP offices across the country, will include smokers who want to quit smoking to test this app. The intervention group (n=310) will be a group of smokers where the GP uses the app to help them quit smoking, while the control group (n=310) will be smokers who only receive regular smoking cessation treatment as is currently provided by GPs. The health benefits of increased smoking cessation success rates are major, including prevention of various cancers as well as other chronic smoking-related diseases such as cardiovascular disease and lung disease e.g. COPD. This will in turn provide significant cost savings at a societal level.