A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery (CHAMPION)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms; Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 290

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital, Capital Medical University
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Shanghai, China, 200000
    • Ruijin Hospital, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; No drug will be administered as part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson (China) Investment Ltd.
• Investigators: Study Director: Johnson & Johnson (China) Investment Ltd. Clinical Trial, Johnson & Johnson (China) Investment Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms
• Other Study ID Numbers: CR108767; NOPRODLUC4001 (Other Identifier: Johnson & Johnson (China) Investment Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No