TY - JOUR

T1 - TOB-STOP-COP (TOBacco STOP in COPd trial)

T2 - 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

AU - Saeed, Mohamad Isam

AU - Sivapalan, Pradeesh

AU - Eklöf, Josefin

AU - Ulrik, Charlotte Suppli

AU - Pisinger, Charlotta

AU - Lapperre, Therese

AU - Tønnesen, Philip

AU - Hoyer, Nils

AU - Janner, Julie

AU - Karlsson, Marie Lavesen

AU - Bech, Charlotte Sandau

AU - Marså, Kristoffer

AU - Godtfredsen, Nina

AU - Brøndum, Eva

AU - Munk, Birgit

AU - Raaschou, Merete

AU - Browatzski, Andrea

AU - Lütken, Pernille

AU - Jensen, Jens-Ulrik Stæhr

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

U2 - 10.1186/s13063-020-04653-z

DO - 10.1186/s13063-020-04653-z

M3 - Journal article

C2 - 32825845

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 730

ER -