China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 3
- 主要终点
- Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery
时间窗: 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.
Number of Smoking Cessation Attempts at Baseline Prior to the Surgery
时间窗: Baseline prior to the surgery
Number of smoking cessation attempts at baseline prior to the surgery will be reported.
Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery
时间窗: Month 6 post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 6 post surgery will be reported.
Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery
时间窗: 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.
Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery
时间窗: 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.
Number of Smoking Cessation Attempts at Month 1 Post-surgery
时间窗: Month 1 post-surgery
Number of smoking cessation attempts at Month 1 post-surgery will be reported.
Percentage of Participants Using NRTs at Month 1 Post-surgery
时间窗: Month 1 post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 1 post surgery will be reported.
Percentage of Participants Using NRTs at Month 3 Post-surgery
时间窗: Month 3 post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 3 post surgery will be reported.
Percentage of Participants with Smoking Relapse at Month 3 Post-surgery
时间窗: Month 3 post-surgery
Percentage of participants with smoking relapse at Month 3 post-surgery will be reported.
Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery
时间窗: Baseline Prior to the Surgery
Percentage of smokers and recent smoking quitters at baseline prior to the surgery will be reported.
Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery
时间窗: 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.
Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery
时间窗: Baseline prior to surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at baseline prior to surgery will be reported.
Percentage of Participants with Smoking Relapse at Month 1 Post-surgery
时间窗: Month 1 post-surgery
Percentage of participants with smoking relapse at Month 1 post-surgery will be reported.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery
时间窗: 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.
Number of Smoking Cessation Attempts at Month 3 Post-surgery
时间窗: Month 3 post-surgery
Number of smoking cessation attempts at Month 3 post-surgery will be reported.
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery
时间窗: 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.
Percentage of Participants with Smoking Relapse at Month 6 Post-surgery
时间窗: Month 6 post-surgery
Percentage of participants with smoking relapse at Month 6 post-surgery will be reported.
Overall Incidence of PCs and PPCs Post-surgery (Within 6 Months Post-surgery) and by Baseline Smoking Status
时间窗: 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.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery
时间窗: Baseline prior to surgery
Percentage of participants who received advice from HCPs to quit smoking at baseline prior to surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery
时间窗: Month 6 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 6 post-surgery will be reported.
Number of Smoking Cessation Attempts at Month 6 Post-surgery
时间窗: Month 6 post-surgery
Number of smoking cessation attempts at Month 6 post-surgery will be reported.
Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline
时间窗: Baseline
Number of participants who used prior methods and medications for smoking cessation at baseline will be reported.
Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery
时间窗: Month 1 post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 1 post-surgery will be reported.
Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery
时间窗: Month 3 post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 3 post-surgery will be reported.
Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery
时间窗: Month 6 post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 6 post-surgery will be reported.
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery
时间窗: 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.
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery
时间窗: 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.
Overall Incidence of PCs and PPCs Post-surgery (Within 2 Weeks After Surgery) and by Baseline Smoking Status
时间窗: 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.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery
时间窗: Month 3 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 3 post-surgery will be reported.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery
时间窗: Month 6 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 6 post-surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery
时间窗: Month 3 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 3 post-surgery will be reported.
Overall Incidence of Postoperative Complications (PCs) and Postoperative Pulmonary Complications (PPCs) Post-surgery (at 1 Day Prior to Discharge)and by Baseline Smoking Status
时间窗: 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.
Overall Incidence of PCs and PPCs Post-surgery (Within 3 Months Post-surgery) and by Baseline Smoking Status
时间窗: 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.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery
时间窗: Month 1 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 1 post-surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
时间窗: Month 1 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 1 post-surgery will be reported.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery
时间窗: 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.
Overall Incidence of PCs and PPCs Post-surgery (Within 1 Month Post-surgery) and by Baseline Smoking Status
时间窗: 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.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery
时间窗: 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.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery
时间窗: 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.
次要结局
未报告次要终点