Clinical trial NCT04313361: A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery
Official title: China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Johnson & Johnson (China) Investment Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 290
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery
timeFrame: Baseline Prior to the Surgery
measure: Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery
timeFrame: Baseline Prior to the Surgery
measure: Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery
timeFrame: Month 6 post-surgery
measure: Number of Smoking Cessation Attempts at Baseline Prior to the Surgery
timeFrame: Baseline prior to the surgery
measure: Number of Smoking Cessation Attempts at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Number of Smoking Cessation Attempts at Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Number of Smoking Cessation Attempts at Month 6 Post-surgery
timeFrame: Month 6 post-surgery
measure: Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline
timeFrame: Baseline
measure: Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery
timeFrame: Month 6 post-surgery
measure: Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery
timeFrame: Baseline prior to surgery
measure: Percentage of Participants Using NRTs at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Percentage of Participants Using NRTs at Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery
timeFrame: Month 6 post-surgery
measure: Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery
timeFrame: Month 6 post-surgery
measure: Percentage of Participants with Smoking Relapse at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Percentage of Participants with Smoking Relapse at Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Percentage of Participants with Smoking Relapse at Month 6 Post-surgery
timeFrame: Month 6 post-surgery
measure: Overall Incidence of Postoperative Complications (PCs) and Postoperative Pulmonary Complications (PPCs) Post-surgery (at 1 Day Prior to Discharge)and by Baseline Smoking Status
timeFrame: At 1 day prior to discharge
measure: Overall Incidence of PCs and PPCs Post-surgery (Within 2 Weeks After Surgery) and by Baseline Smoking Status
timeFrame: Within 2 weeks after surgery
measure: Overall Incidence of PCs and PPCs Post-surgery (Within 1 Month Post-surgery) and by Baseline Smoking Status
timeFrame: Within 1 month post-surgery
measure: Overall Incidence of PCs and PPCs Post-surgery (Within 3 Months Post-surgery) and by Baseline Smoking Status
timeFrame: Within 3 months post-surgery
measure: Overall Incidence of PCs and PPCs Post-surgery (Within 6 Months Post-surgery) and by Baseline Smoking Status
timeFrame: Within 6 months post-surgery
measure: Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery
timeFrame: Baseline prior to surgery
measure: Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery
timeFrame: Month 3 post-surgery
measure: Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery
timeFrame: Month 6 post-surgery
measure: Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
timeFrame: Baseline prior to surgery
measure: Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
timeFrame: Month 1 post-surgery
measure: Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery
timeFrame: Month 3 post-surgery
measure: Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery
timeFrame: Month 6 post-surgery
measure: Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery
timeFrame: Baseline prior to surgery
measure: Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery
timeFrame: Month 1 post-surgery
measure: Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery
timeFrame: Month 3 post-surgery
measure: Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery
timeFrame: Month 6 post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital ,Capital Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
Study officials:
affiliation: Johnson & Johnson (China) Investment Ltd.
name: Johnson & Johnson (China) Investment Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: