Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2025-12-25 @ 12:09 PM
Study NCT ID:
NCT04313361
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2020-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery', 'timeFrame': 'Baseline Prior to the Surgery', 'description': 'Percentage of smokers and recent smoking quitters at baseline prior to the surgery will be reported.'}, {'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', 'description': "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."}, {'measure': 'Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': "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."}, {'measure': 'Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': "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."}, {'measure': 'Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': "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."}, {'measure': 'Number of Smoking Cessation Attempts at Baseline Prior to the Surgery', 'timeFrame': 'Baseline prior to the surgery', 'description': 'Number of smoking cessation attempts at baseline prior to the surgery will be reported.'}, {'measure': 'Number of Smoking Cessation Attempts at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': 'Number of smoking cessation attempts at Month 1 post-surgery will be reported.'}, {'measure': 'Number of Smoking Cessation Attempts at Month 3 Post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Number of smoking cessation attempts at Month 3 post-surgery will be reported.'}, {'measure': 'Number of Smoking Cessation Attempts at Month 6 Post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Number of smoking cessation attempts at Month 6 post-surgery will be reported.'}, {'measure': 'Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline', 'timeFrame': 'Baseline', 'description': 'Number of participants who used prior methods and medications for smoking cessation at baseline will be reported.'}, {'measure': 'Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': 'Number of participants who used current methods or medication for smoking cessation at Month 1 post-surgery will be reported.'}, {'measure': 'Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Number of participants who used current methods or medication for smoking cessation at Month 3 post-surgery will be reported.'}, {'measure': 'Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Number of participants who used current methods or medication for smoking cessation at Month 6 post-surgery will be reported.'}, {'measure': 'Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery', 'timeFrame': 'Baseline prior to surgery', 'description': 'Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at baseline prior to surgery will be reported.'}, {'measure': 'Percentage of Participants Using NRTs at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': 'Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 1 post surgery will be reported.'}, {'measure': 'Percentage of Participants Using NRTs at Month 3 Post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 3 post surgery will be reported.'}, {'measure': 'Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 6 post surgery will be reported.'}, {'measure': 'Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': '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.'}, {'measure': 'Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 3 post-surgery will be reported.'}, {'measure': 'Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 6 post-surgery will be reported.'}, {'measure': 'Percentage of Participants with Smoking Relapse at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': 'Percentage of participants with smoking relapse at Month 1 post-surgery will be reported.'}, {'measure': 'Percentage of Participants with Smoking Relapse at Month 3 Post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Percentage of participants with smoking relapse at Month 3 post-surgery will be reported.'}, {'measure': 'Percentage of Participants with Smoking Relapse at Month 6 Post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Percentage of participants with smoking relapse at Month 6 post-surgery will be reported.'}, {'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', 'description': 'Overall incidence of PCs and PPCs post-surgery (at 1 day prior to discharge) and by baseline smoking status will be reported.'}, {'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', 'description': 'Overall incidence of PCs and PPCs post-surgery (within 2 weeks after surgery) and by baseline smoking status will be reported.'}, {'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', 'description': 'Overall incidence of PCs and PPCs post-surgery (within 1 month post-surgery) and by baseline smoking status will be reported.'}, {'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', 'description': 'Overall incidence of PCs and PPCs post-surgery (within 3 months post-surgery) and by baseline smoking status will be reported.'}, {'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', 'description': 'Overall incidence of PCs and PPCs post-surgery (within 6 months post-surgery) and by baseline smoking status will be reported.'}, {'measure': 'Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery', 'timeFrame': 'Baseline prior to surgery', 'description': 'Percentage of participants who received advice from HCPs to quit smoking at baseline prior to surgery will be reported.'}, {'measure': 'Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery', 'timeFrame': 'Month 1 post-surgery', 'description': 'Percentage of participants who received advice from HCPs to quit smoking at Month 1 post-surgery will be reported.'}, {'measure': 'Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Percentage of participants who received advice from HCPs to quit smoking at Month 3 post-surgery will be reported.'}, {'measure': 'Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Percentage of participants who received advice from HCPs to quit smoking at Month 6 post-surgery will be reported.'}, {'measure': 'Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery', 'timeFrame': 'Baseline prior to surgery', 'description': 'Percentage of specific smoking cessation methods and service participants received from HCPs at baseline prior to surgery will be reported.'}, {'measure': 'Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery', 'timeFrame': 'Month 1 post-surgery', 'description': 'Percentage of specific smoking cessation methods and service participants received from HCPs at Month 1 post-surgery will be reported.'}, {'measure': 'Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery', 'timeFrame': 'Month 3 post-surgery', 'description': 'Percentage of specific smoking cessation methods and service participants received from HCPs at Month 3 post-surgery will be reported.'}, {'measure': 'Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery', 'timeFrame': 'Month 6 post-surgery', 'description': 'Percentage of specific smoking cessation methods and service participants received from HCPs at Month 6 post-surgery will be reported.'}, {'measure': "Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery", 'timeFrame': 'Baseline prior to surgery', 'description': "Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at baseline prior to surgery will be reported."}, {'measure': "Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery", 'timeFrame': 'Month 1 post-surgery', 'description': "Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 1 post-surgery will be reported."}, {'measure': "Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery", 'timeFrame': 'Month 3 post-surgery', 'description': "Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 3 post-surgery will be reported."}, {'measure': "Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery", 'timeFrame': 'Month 6 post-surgery', 'description': "Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 6 post-surgery will be reported."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Neoplasms', 'Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* 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\n* Being willing to participate the study and sign the participant informed consent form (ICF)\n\nExclusion Criteria:\n\n* Participants who have emergency lung surgery due to accident or injury\n* Participants are not likely to be able to complete the 6-month follow-up after the lung surgery"}, 'identificationModule': {'nctId': 'NCT04313361', 'acronym': 'CHAMPION', 'briefTitle': 'A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson (China) Investment Ltd.'}, 'officialTitle': 'China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)', 'orgStudyIdInfo': {'id': 'CR108767'}, 'secondaryIdInfos': [{'id': 'NOPRODLUC4001', 'type': 'OTHER', 'domain': 'Johnson & Johnson (China) Investment Ltd.'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers or Recent Smoking Quitters who Have lung Surgery', 'description': "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.", 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No drug will be administered as part of this study.', 'armGroupLabels': ['Smokers or Recent Smoking Quitters who Have lung Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'country': 'China', 'facility': 'Xuanwu Hospital ,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510120', 'city': 'Guangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200000', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Johnson & Johnson (China) Investment Ltd. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson (China) Investment Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson (China) Investment Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}