TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol—a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of “high-intensity” vs. “low-intensity” smoking cessation intervention in active smokers with chronic obstructive pulmonary disease
Mohamad Isam Saeed,
Pradeesh Sivapalan,
Josefin Eklöf,
Charlotte Suppli Ulrik,
Charlotta Pisinger,
Therese Lapperre,
Philip Tønnesen,
Nils Hoyer,
Julie Janner,
Marie Lavesen Karlsson,
Charlotte Sandau Bech,
Kristoffer Marså,
Nina Godtfredsen,
Eva Brøndum,
Birgit Munk,
Merete Raaschou,
Andrea Browatzski,
Pernille Lütken,
Jens-Ulrik Stæhr Jensen
Affiliations
Mohamad Isam Saeed
Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital
Pradeesh Sivapalan
Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital
Josefin Eklöf
Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital
Charlotte Suppli Ulrik
Department of Respiratory Medicine, Hvidovre University Hospital
Charlotta Pisinger
Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital
Therese Lapperre
Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital
Philip Tønnesen
Department of Respiratory Medicine, Rigshospitalet
Nils Hoyer
Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital
Julie Janner
Department of Respiratory Medicine, Hvidovre University Hospital
Marie Lavesen Karlsson
Department of Respiratory and Infectious Medicine, Nordsjællands Hospital
Charlotte Sandau Bech
Department of Respiratory Medicine, Hvidovre University Hospital
Kristoffer Marså
Palliation Unit, Herlev and Gentofte University Hospital
Nina Godtfredsen
Department of Respiratory Medicine, Hvidovre University Hospital
Eva Brøndum
Department of Respiratory Medicine, Hvidovre University Hospital
Birgit Munk
Rygestopcaféen, Hvidovre University Hospital
Merete Raaschou
Patient Representative
Andrea Browatzski
Department of Respiratory and Infectious Medicine, Nordsjællands Hospital
Pernille Lütken
Rygestopkonsulenterne ApS
Jens-Ulrik Stæhr Jensen
Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital
Abstract Background Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15–20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD. Methods This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, “low intensity” group) or an intervention (“high-intensity” group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and “buddy-matching” (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months. Discussion The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases. Trial registration ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019
