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Completed

NCT Number: NCT04313361

A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery

The purpose of this study is to assess the current smoking status and smoking cessation attempts among smokers or recent smoking quitters during the perioperative period, to describe postoperative pulmonary complications (PPCs) and other postoperative complications (PCs) following a lung surgery, and to describe the smoking cessation methods and services patients received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example, nodule, or ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China.

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Key information

Conditions

Lung Neoplasms Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital ,Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who have been scheduled for an elective lung surgery by the treating physician's judgement, due to the following conditions: known lung cancer, COPD, a pulmonary lesion (example. nodule, ground glass opacity) or other pulmonary conditions
  • Smokers who are or were smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years within 3 months prior to the scheduled surgery, or recent smoking quitters with a history of smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years, who quit smoking between 3 months and 5 years prior to the scheduled surgery
  • Being willing to participate the study and sign the participant informed consent form (ICF)

Exclusion criteria

  • Participants who have emergency lung surgery due to accident or injury
  • Participants are not likely to be able to complete the 6-month follow-up after the lung surgery

Treatment and study plan

No intervention

Other

No drug will be administered as part of this study.

Primary outcomes

  1. Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery

    Time frame: Baseline Prior to the Surgery

    Percentage of smokers and recent smoking quitters at baseline prior to the surgery will be reported.

  2. Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery

    Time frame: Baseline Prior to the Surgery

    Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.

  3. Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.

  4. Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.

  5. Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.

  6. Number of Smoking Cessation Attempts at Baseline Prior to the Surgery

    Time frame: Baseline prior to the surgery

    Number of smoking cessation attempts at baseline prior to the surgery will be reported.

  7. Number of Smoking Cessation Attempts at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Number of smoking cessation attempts at Month 1 post-surgery will be reported.

  8. Number of Smoking Cessation Attempts at Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Number of smoking cessation attempts at Month 3 post-surgery will be reported.

  9. Number of Smoking Cessation Attempts at Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Number of smoking cessation attempts at Month 6 post-surgery will be reported.

  10. Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline

    Time frame: Baseline

    Number of participants who used prior methods and medications for smoking cessation at baseline will be reported.

  11. Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Number of participants who used current methods or medication for smoking cessation at Month 1 post-surgery will be reported.

  12. Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Number of participants who used current methods or medication for smoking cessation at Month 3 post-surgery will be reported.

  13. Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Number of participants who used current methods or medication for smoking cessation at Month 6 post-surgery will be reported.

  14. Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery

    Time frame: Baseline prior to surgery

    Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at baseline prior to surgery will be reported.

  15. Percentage of Participants Using NRTs at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 1 post surgery will be reported.

  16. Percentage of Participants Using NRTs at Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 3 post surgery will be reported.

  17. Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 6 post surgery will be reported.

  18. Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Percentage of participants with self-reported smoking abstinence and 7-days/30-day point prevalence of smoking at Month 1 post-surgery will be reported.

  19. Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 3 post-surgery will be reported.

  20. Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 6 post-surgery will be reported.

  21. Percentage of Participants with Smoking Relapse at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Percentage of participants with smoking relapse at Month 1 post-surgery will be reported.

  22. Percentage of Participants with Smoking Relapse at Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Percentage of participants with smoking relapse at Month 3 post-surgery will be reported.

  23. Percentage of Participants with Smoking Relapse at Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Percentage of participants with smoking relapse at Month 6 post-surgery will be reported.

  24. Overall Incidence of Postoperative Complications (PCs) and Postoperative Pulmonary Complications (PPCs) Post-surgery (at 1 Day Prior to Discharge)and by Baseline Smoking Status

    Time frame: At 1 day prior to discharge

    Overall incidence of PCs and PPCs post-surgery (at 1 day prior to discharge) and by baseline smoking status will be reported.

  25. Overall Incidence of PCs and PPCs Post-surgery (Within 2 Weeks After Surgery) and by Baseline Smoking Status

    Time frame: Within 2 weeks after surgery

    Overall incidence of PCs and PPCs post-surgery (within 2 weeks after surgery) and by baseline smoking status will be reported.

  26. Overall Incidence of PCs and PPCs Post-surgery (Within 1 Month Post-surgery) and by Baseline Smoking Status

    Time frame: Within 1 month post-surgery

    Overall incidence of PCs and PPCs post-surgery (within 1 month post-surgery) and by baseline smoking status will be reported.

  27. Overall Incidence of PCs and PPCs Post-surgery (Within 3 Months Post-surgery) and by Baseline Smoking Status

    Time frame: Within 3 months post-surgery

    Overall incidence of PCs and PPCs post-surgery (within 3 months post-surgery) and by baseline smoking status will be reported.

  28. Overall Incidence of PCs and PPCs Post-surgery (Within 6 Months Post-surgery) and by Baseline Smoking Status

    Time frame: Within 6 months post-surgery

    Overall incidence of PCs and PPCs post-surgery (within 6 months post-surgery) and by baseline smoking status will be reported.

  29. Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery

    Time frame: Baseline prior to surgery

    Percentage of participants who received advice from HCPs to quit smoking at baseline prior to surgery will be reported.

  30. Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Percentage of participants who received advice from HCPs to quit smoking at Month 1 post-surgery will be reported.

  31. Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery

    Time frame: Month 3 post-surgery

    Percentage of participants who received advice from HCPs to quit smoking at Month 3 post-surgery will be reported.

  32. Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery

    Time frame: Month 6 post-surgery

    Percentage of participants who received advice from HCPs to quit smoking at Month 6 post-surgery will be reported.

  33. Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery

    Time frame: Baseline prior to surgery

    Percentage of specific smoking cessation methods and service participants received from HCPs at baseline prior to surgery will be reported.

  34. Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery

    Time frame: Month 1 post-surgery

    Percentage of specific smoking cessation methods and service participants received from HCPs at Month 1 post-surgery will be reported.

  35. Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery

    Time frame: Month 3 post-surgery

    Percentage of specific smoking cessation methods and service participants received from HCPs at Month 3 post-surgery will be reported.

  36. Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery

    Time frame: Month 6 post-surgery

    Percentage of specific smoking cessation methods and service participants received from HCPs at Month 6 post-surgery will be reported.

  37. Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery

    Time frame: Baseline prior to surgery

    Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at baseline prior to surgery will be reported.

  38. Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery

    Time frame: Month 1 post-surgery

    Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 1 post-surgery will be reported.

  39. Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery

    Time frame: Month 3 post-surgery

    Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 3 post-surgery will be reported.

  40. Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery

    Time frame: Month 6 post-surgery

    Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 6 post-surgery will be reported.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson (China) Investment Ltd.

Industry

Registry information

Official study title

China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)

Acronym: CHAMPION

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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