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Lung NeoplasmsCHAMPIONNCT04313361

A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery

An observational study of Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Johnson & Johnson (China) Investment Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 years
How many people
290 participants
Where
3 sitesChina
Study dates
6 May 2020to 9 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites
  • Xuanwu Hospital ,Capital Medical University

    Beijing, 100053

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200000

Other trials in China

About this study

Official title: 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.

Being tested
No intervention
Medical subject headings
Lung Neoplasms, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No drug will be administered as part of this study.

Study groups in NCT04313361
Study groupRoleWhat they receive
Smokers or Recent Smoking Quitters who Have lung SurgeryThe 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.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline Prior to the Surgery

  2. 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.

    Measured: Baseline Prior to the Surgery

  3. 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.

    Measured: Month 1 post-surgery

  4. 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.

    Measured: Month 3 post-surgery

  5. 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.

    Measured: Month 6 post-surgery

  6. 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.

    Measured: Baseline prior to the surgery

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

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

    Measured: Month 1 post-surgery

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

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

    Measured: Month 3 post-surgery

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

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

    Measured: Month 6 post-surgery

  10. 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.

    Measured: Baseline

  11. 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.

    Measured: Month 1 post-surgery

  12. 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.

    Measured: Month 3 post-surgery

  13. 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.

    Measured: Month 6 post-surgery

  14. 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.

    Measured: Baseline prior to surgery

  15. 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.

    Measured: Month 1 post-surgery

  16. 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.

    Measured: Month 3 post-surgery

  17. 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.

    Measured: Month 6 post-surgery

  18. 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.

    Measured: Month 1 post-surgery

  19. 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.

    Measured: Month 3 post-surgery

  20. 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.

    Measured: Month 6 post-surgery

  21. 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.

    Measured: Month 1 post-surgery

  22. 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.

    Measured: Month 3 post-surgery

  23. 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.

    Measured: Month 6 post-surgery

  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

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

    Measured: At 1 day prior to discharge

  25. 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.

    Measured: Within 2 weeks after surgery

  26. 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.

    Measured: Within 1 month post-surgery

  27. 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.

    Measured: Within 3 months post-surgery

  28. 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.

    Measured: Within 6 months post-surgery

  29. 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.

    Measured: Baseline prior to surgery

  30. 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.

    Measured: Month 1 post-surgery

  31. 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.

    Measured: Month 3 post-surgery

  32. 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.

    Measured: Month 6 post-surgery

  33. 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.

    Measured: Baseline prior to surgery

  34. 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.

    Measured: Month 1 post-surgery

  35. 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.

    Measured: Month 3 post-surgery

  36. 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.

    Measured: Month 6 post-surgery

  37. 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.

    Measured: Baseline prior to surgery

  38. 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.

    Measured: Month 1 post-surgery

  39. 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.

    Measured: Month 3 post-surgery

  40. 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.

    Measured: Month 6 post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start6 May 2020
  3. Primary completion9 Dec 2021
  4. Study completion9 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313361
Sponsor's protocol ID
CR108767
Other IDs
NOPRODLUC4001
Acronym
CHAMPION
Status last verified
Apr 2025
First submitted
5 Mar 2020
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Johnson & Johnson (China) Investment Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery (time frame: Baseline Prior to the Surgery). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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