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

April 25, 2025 updated by: Johnson & Johnson (China) Investment Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline Prior to the Surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Baseline prior to the surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Baseline
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Baseline prior to surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
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
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.
At 1 day prior to discharge
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.
Within 2 weeks after surgery
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.
Within 1 month post-surgery
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.
Within 3 months post-surgery
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.
Within 6 months post-surgery
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.
Baseline prior to surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Baseline prior to surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery
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.
Baseline prior to surgery
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.
Month 1 post-surgery
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.
Month 3 post-surgery
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.
Month 6 post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson (China) Investment Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson & Johnson (China) Investment Ltd. Clinical Trial, Johnson & Johnson (China) Investment Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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