A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery

NCT04313361 | Completed

• 2 other identifiers: CR108767NOPRODLUC4001
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (40)

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

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

  Baseline Prior to the Surgery

• Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at 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.

  Baseline Prior to the Surgery

• Smoking Dependence Among Smokers as Measured by FTND Scale at 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.

  Month 1 post-surgery

• Smoking Dependence Among Smokers as Measured by FTND Scaleat 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.

  Month 3 post-surgery

• Smoking Dependence Among Smokers as Measured by FTND Scaleat 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.

  Month 6 post-surgery

• Number of Smoking Cessation Attempts at Baseline Prior to the Surgery

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

  Baseline prior to the surgery

• Number of Smoking Cessation Attempts at Month 1 Post-surgery

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

  Month 1 post-surgery

• Number of Smoking Cessation Attempts at Month 3 Post-surgery

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

  Month 3 post-surgery

• Number of Smoking Cessation Attempts at Month 6 Post-surgery

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

  Month 6 post-surgery

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

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

  Baseline

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

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

  Month 1 post-surgery

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

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

  Month 3 post-surgery

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

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

  Month 6 post-surgery

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

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

  Baseline prior to surgery

• Percentage of Participants Using NRTs at Month 1 Post-surgery

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

  Month 1 post-surgery

• Percentage of Participants Using NRTs at Month 3 Post-surgery

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

  Month 3 post-surgery

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

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

  Month 6 post-surgery

• Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at 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.

  Month 1 post-surgery

• Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at 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.

  Month 3 post-surgery

• Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at 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.

  Month 6 post-surgery

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

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

  Month 1 post-surgery

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

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

  Month 3 post-surgery

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

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

  Month 6 post-surgery

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

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

  At 1 day prior to discharge

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

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

  Within 2 weeks after surgery

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

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

  Within 1 month post-surgery

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

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

  Within 3 months post-surgery

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

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

  Within 6 months post-surgery

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

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

  Baseline prior to surgery

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

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

  Month 1 post-surgery

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

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

  Month 3 post-surgery

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

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

  Month 6 post-surgery

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

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

  Baseline prior to surgery

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

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

  Month 1 post-surgery

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

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

  Month 3 post-surgery

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

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

  Month 6 post-surgery

• Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at 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.

  Baseline prior to surgery

• Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at 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.

  Month 1 post-surgery

• Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at 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.

  Month 3 post-surgery

• Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at 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.

  Month 6 post-surgery

Study Arms (1)

Smokers or Recent Smoking Quitters who Have lung Surgery

The enrolled eligible participants, that is smokers or recent smoking quitters, will be assessed for the current smoking status and smoking cessation attempts during the perioperative period, to describe postoperative complications (PCs) including postoperative pulmonary complications (PPCs) following a lung surgery, and to describe the smoking cessation methods and services participants 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, ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China.

Other: No intervention

Interventions

No intervention OTHER

No drug will be administered as part of this study.

Smokers or Recent Smoking Quitters who Have lung Surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes adult participant with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion, or other pulmonary conditions with a scheduled lung surgery and their treating health care providers (HCPs) from three participating hospitals in China.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson (China) Investment Ltd.: lead

Study Sites (3)

Xuanwu Hospital ,Capital Medical University

Beijing, 100053, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Johnson & Johnson (China) Investment Ltd. Clinical Trial

  Johnson & Johnson (China) Investment Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 18, 2020
• Study Start: May 6, 2020
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)