Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-04 @ 9:08 AM
Study NCT ID:
NCT02482233
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The END Perioperative Smoking Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}, {'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susanlee.anesthesia@gmail.com', 'phone': '604-520-4253', 'title': 'Dr. Susan Ming Lee', 'organization': 'Royal Columbian Hospital / University of British Columbia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry cough (persistent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry cough (intermittent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'notes': 'includes (for NRT group) irritable mood, patch not sticking properly, increased cravings, jitteriness, diarrhea, dry mouth, anxiety, sleepiness and (for END group) wheezing, productive cough, choking sense, poor appetite, burning sensation, lip burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of surgery (expected average around 1-2 weeks after enrollment/randomization)', 'description': 'Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide \\<10ppm.\n\nTime Frame depends on date of preadmission clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Use of Product - Number Reporting Use Daily or Most Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8-weeks', 'description': 'how often product (e-cigarette or patch) was used (everyday except while hospitalized, most days, a few times a week, once a week, less than once a week, not at all)\n\nResult reported is those that used the product daily or most days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'in-person visit at 8-weeks, or make-up phone call if unavailable in-person'}, {'type': 'SECONDARY', 'title': 'Report of How Helpful the Product Was for Quitting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'as above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'as above'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-weeks', 'description': '7-point likert scale (strongly disagree to strongly agree)\n\n1. strongly disagree\n2. disagree\n3. disagree somewhat\n4. neither agree nor disagree\n5. agree somewhat\n6. agree\n7. strongly agree', 'unitOfMeasure': 'units on a scale out of 7', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'How Satisfied the Patient Was With the Product (E-cigarette or Patch)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'as above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'as above'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-weeks', 'description': '7-point likert scale (strongly disagree to strongly agree)\n\n1. strongly disagree\n2. disagree\n3. disagree somewhat\n4. neither agree nor disagree\n5. agree somewhat\n6. agree\n7. strongly agree', 'unitOfMeasure': 'units on a scale out of 7', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'as above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'as above'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '7'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-weeks', 'description': '7-point likert scale (strongly disagree to strongly agree)\n\n1. strongly disagree\n2. disagree\n3. disagree somewhat\n4. neither agree nor disagree\n5. agree somewhat\n6. agree\n7. strongly agree', 'unitOfMeasure': 'units on a scale out of 7', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8-weeks', 'description': 'by self-report and confirmed by exhaled CO\\<10ppm - confirmed abstinent', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Those lost to follow-up assumed to still be smoking (1 in NRT group). Those who had telephone interview were unable to have exhaled CO verification (n=1 in NRT group, n=2 in END group). Since they were not verified by exhaled CO, they were not considered abstinent.'}, {'type': 'SECONDARY', 'title': 'Smoking Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'on day of surgery and 8-weeks after randomization', 'description': '50% or less regular cigarette use compared to baseline as determined by asking participants to self-report daily cigarette use in cigarettes per day at each time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dual Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'on day of surgery and 8-weeks after randomization', 'description': 'use of both regular and e-cigarettes concurrently', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spirometry - FEV1/FVC Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'title': 'FEV1/FVC on day of surgery compared to baseline', 'categories': [{'measurements': [{'value': '-32.2', 'spread': '74', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'FEV1/FVC at 8 weeks compared to baseline', 'categories': [{'measurements': [{'value': '-38.1', 'spread': '79.2', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of surgery and 8-weeks', 'description': 'Change in FEV1/FVC from baseline to day of surgery / 8-weeks. FEV1/FVC is expressed in percent. For example, if FEV1/FVC was 75%, 80%, and 85% at baseline, day of surgery and 8-weeks, result is reported as change in FEV1/FVC being +5% and +10% for day of surgery and 8-weeks respectively.', 'unitOfMeasure': 'percent (change from baseline)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spirometry - FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'title': 'change in FEV1 day of surgery', 'categories': [{'measurements': [{'value': '-236', 'spread': '585', 'groupId': 'OG000'}, {'value': '-163', 'spread': '549', 'groupId': 'OG001'}]}]}, {'title': 'change in FEV1 8-weeks', 'categories': [{'measurements': [{'value': '-300', 'spread': '497', 'groupId': 'OG000'}, {'value': '292', 'spread': '503', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of surgery and 8-weeks', 'description': 'change in FEV1 (mL) compared to baseline', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cotinine Level (Change in)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'title': 'day of surgery', 'categories': [{'measurements': [{'value': '106', 'spread': '137', 'groupId': 'OG000'}, {'value': '19', 'spread': '119', 'groupId': 'OG001'}]}]}, {'title': '8-weeks', 'categories': [{'measurements': [{'value': '34', 'spread': '89', 'groupId': 'OG000'}, {'value': '-48', 'spread': '103', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of surgery and 8-weeks', 'description': 'salivary', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Complications (Composite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'title': 'by chart review', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'by telephone self-report', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-days postop', 'description': 'by chart review - research assistant or investigator examined notes and investigations postoperatively for complications by telephone self-report - patients were asked open-ended question about whether they experienced any postoperative complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Long-term Smoking Status - Use of Conventional Cigarettes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'by self-report (7-day point prevalence)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'those lost assumed to still be smoking'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'title': 'any adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'moderate adverse event (required intervention)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'all patients will be asked about adverse events each time they are contacted (day of surgery, 30-days postoperatively, and 8-weeks after randomization), and they will also be able to call to report adverse events to the study team any time during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Postoperative Complications (Composite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As above'}, {'id': 'OG001', 'title': 'Electronic Cigarette (END)', 'description': 'As above'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-days postop', 'description': 'by telephone self-report', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Replacement Patch Group (Control)', 'description': 'Patients randomized to the NRT group received a 6-week supply of NicodermCQ patches (5 weeks) and placebo patches (1 week) appropriate to baseline nicotine consumption.'}, {'id': 'FG001', 'title': 'Electronic Cigarette (END) Group', 'description': 'Those allocated to the END group received a 6-week supply of NJOY e-cigarettes (Scottsdale, AZ, USA) and were instructed to use the Bold (4.5%) e-cigarettes ad libitum for 3 weeks, the Gold (2.4%) e-cigarettes ad libitum for 2 weeks and the Study (0%) ecigarettes ad libitum for the final week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Replacement Therapy (NRT)', 'description': 'As described above'}, {'id': 'BG001', 'title': 'Electronic Cigarette (END)', 'description': 'As described above'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '54', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '54', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Day seen prior to surgery', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '11.2', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '13.0', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart disease', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COPD', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '13.8', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of years smoking', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '32', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '32', 'spread': '15.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fagerstrom score', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Fagerstrom is a validated scale for nicotine dependence. Higher score indicates more dependence. (min 1 max 10) 1-2 = low, 3-4 = low/mod, 5-7 = moderate, 8+ = high dependence', 'unitOfMeasure': 'units on a scale out of 10 min 1 max 10', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Salivary cotinine (ng/ml)', 'classes': [{'categories': [{'measurements': [{'value': '130.1', 'spread': '75.3', 'groupId': 'BG000'}, {'value': '209.6', 'spread': '110.3', 'groupId': 'BG001'}, {'value': '183.1', 'spread': '98.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exhaled CO (ppm)', 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '21.7', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ppm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 (L)', 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'spread': '1.35', 'groupId': 'BG000'}, {'value': '2.78', 'spread': '1.11', 'groupId': 'BG001'}, {'value': '2.9', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FVC (L)', 'classes': [{'categories': [{'measurements': [{'value': '3.52', 'spread': '1.28', 'groupId': 'BG000'}, {'value': '4.03', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '1.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1/FVC (%)', 'classes': [{'categories': [{'measurements': [{'value': '105', 'spread': '81.3', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '80.5', 'spread': '35.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2015-06-17', 'resultsFirstSubmitDate': '2018-11-09', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-23', 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)', 'timeFrame': 'day of surgery (expected average around 1-2 weeks after enrollment/randomization)', 'description': 'Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide \\<10ppm.\n\nTime Frame depends on date of preadmission clinic visit'}], 'secondaryOutcomes': [{'measure': 'Frequency of Use of Product - Number Reporting Use Daily or Most Days', 'timeFrame': '8-weeks', 'description': 'how often product (e-cigarette or patch) was used (everyday except while hospitalized, most days, a few times a week, once a week, less than once a week, not at all)\n\nResult reported is those that used the product daily or most days'}, {'measure': 'Report of How Helpful the Product Was for Quitting', 'timeFrame': '8-weeks', 'description': '7-point likert scale (strongly disagree to strongly agree)\n\n1. strongly disagree\n2. disagree\n3. disagree somewhat\n4. neither agree nor disagree\n5. agree somewhat\n6. agree\n7. strongly agree'}, {'measure': 'How Satisfied the Patient Was With the Product (E-cigarette or Patch)', 'timeFrame': '8-weeks', 'description': '7-point likert scale (strongly disagree to strongly agree)\n\n1. strongly disagree\n2. disagree\n3. disagree somewhat\n4. neither agree nor disagree\n5. agree somewhat\n6. agree\n7. strongly agree'}, {'measure': 'How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others', 'timeFrame': '8-weeks', 'description': '7-point likert scale (strongly disagree to strongly agree)\n\n1. strongly disagree\n2. disagree\n3. disagree somewhat\n4. neither agree nor disagree\n5. agree somewhat\n6. agree\n7. strongly agree'}, {'measure': 'Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)', 'timeFrame': '8-weeks', 'description': 'by self-report and confirmed by exhaled CO\\<10ppm - confirmed abstinent'}, {'measure': 'Smoking Reduction', 'timeFrame': 'on day of surgery and 8-weeks after randomization', 'description': '50% or less regular cigarette use compared to baseline as determined by asking participants to self-report daily cigarette use in cigarettes per day at each time point.'}, {'measure': 'Number of Participants With Dual Use', 'timeFrame': 'on day of surgery and 8-weeks after randomization', 'description': 'use of both regular and e-cigarettes concurrently'}, {'measure': 'Spirometry - FEV1/FVC Change', 'timeFrame': 'day of surgery and 8-weeks', 'description': 'Change in FEV1/FVC from baseline to day of surgery / 8-weeks. FEV1/FVC is expressed in percent. For example, if FEV1/FVC was 75%, 80%, and 85% at baseline, day of surgery and 8-weeks, result is reported as change in FEV1/FVC being +5% and +10% for day of surgery and 8-weeks respectively.'}, {'measure': 'Spirometry - FEV1', 'timeFrame': 'day of surgery and 8-weeks', 'description': 'change in FEV1 (mL) compared to baseline'}, {'measure': 'Cotinine Level (Change in)', 'timeFrame': 'day of surgery and 8-weeks', 'description': 'salivary'}, {'measure': 'Number of Participants With Postoperative Complications (Composite)', 'timeFrame': '30-days postop', 'description': 'by chart review - research assistant or investigator examined notes and investigations postoperatively for complications by telephone self-report - patients were asked open-ended question about whether they experienced any postoperative complications'}, {'measure': 'Long-term Smoking Status - Use of Conventional Cigarettes', 'timeFrame': '6 months', 'description': 'by self-report (7-day point prevalence)'}, {'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '8 weeks', 'description': 'all patients will be asked about adverse events each time they are contacted (day of surgery, 30-days postoperatively, and 8-weeks after randomization), and they will also be able to call to report adverse events to the study team any time during the study.'}, {'measure': 'Number of Participants Postoperative Complications (Composite)', 'timeFrame': '30-days postop', 'description': 'by telephone self-report'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electronic cigarette', 'nicotine replacement therapy', 'smoking cessation', 'perioperative'], 'conditions': ['Smoking', 'Nicotine Addiction', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '30280019', 'type': 'RESULT', 'citation': 'Lee SM, Tenney R, Wallace AW, Arjomandi M. E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial. PeerJ. 2018 Sep 28;6:e5609. doi: 10.7717/peerj.5609. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'https://peerj.com/articles/5609/', 'label': 'Full peer-reviewed results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead to increased smoking cessation in the perioperative setting in smokers presenting for elective surgery at the San Francisco Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit, hospital length-of-stay, postoperative complications within the first 30-days, and smoking status 8-weeks after randomization. This pilot study is designed to provide the preliminary data necessary to plan and fund a larger-scale randomized clinical trial that will assess the utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking cessation, specifically in the perioperative setting where the risks of continued smoking are great and the motivation to stop is high.', 'detailedDescription': 'It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. Despite this knowledge, it is unclear what clinicians can do to minimize this risk. Surgery represents a \'teachable moment\' that might encourage smokers to engage in permanent cessation. Several small trials have shown that smoking cessation interventions can increase smoking cessation and reduce postoperative complications, particularly wound-healing complications, which can have an absolute risk reduction of up to 25%. Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation. Despite the benefits of comprehensive smoking cessation interventions including nicotine replacement therapy, current standard of care at the SFVAMC does not routinely include specific preoperative smoking cessation pharmacotherapy or counselling. Although there is an urgent need for more data, e-cigarettes have been proposed as an alternative to nicotine replacement therapy that are at least as effective for smoking cessation, and may be more acceptable to some patients.\n\nThe main hypothesis of this pilot study is that the use of e-cigarettes and telephone counselling, compared to telephone counselling and transdermal nicotine replacement, in the perioperative period results in increased smoking cessation on the day of surgery and at 8-weeks after randomization in smokers presenting for elective surgery. As secondary hypotheses, the study will also assess the acceptability of e-cigarettes versus nicotine patches, postoperative complications within the first 30-days, length-of-stay in the PACU and hospital length-of-stay. The investigators will examine the above hypotheses through the following aims:\n\n" Aim 1) To determine how e-cigarettes plus counselling compare to transdermal nicotine replacement plus counselling for the achievement of smoking cessation, when introduced prior to elective surgery in veterans.\n\nThe investigators plan to carry-out a pilot randomized controlled trial with parallel design comparing e-cigarettes and telephone counselling with transdermal nicotine replacement and telephone counselling. Our primary outcome is smoking cessation on the day of surgery, as confirmed biochemically by exhaled carbon monoxide. Smoking reduction (self-reported cigarettes per day) of 50% or more and bedside spirometry readings will be assessed as secondary outcomes.\n\n" Aim 2) To determine the acceptability of e-cigarettes amongst veterans as an aid for smoking cessation and to determine the feasibility of recruitment, randomization, and follow-up procedures in preparation for large-scale trial.\n\nThrough implementation of this pilot trial, the investigators will determine the feasibility and acceptability of e-cigarettes for smoking cessation perioperatively in the veteran population and obtain the preliminary data necessary to run a larger trial on the effectiveness of e-cigarettes as a perioperative smoking cessation aid.\n\n" Aim 3) To determine the safety of e-cigarettes as a harm reduction strategy to achieve short-term perioperative smoking cessation.\n\nThe investigators plan to improve the overall knowledge of the safety of short-term e-cigarettes use through careful surveillance for adverse events and side effects.\n\n" Aim 4) To determine if e-cigarette use preoperatively is associated with a lower risk of complications postoperatively.\n\nThe investigators plan to measure the following secondary outcomes: postoperative complications and mortality within the first 30 days, post-anesthesia care unit (PACU) length-of-stay, and hospital length-of-stay. This will help us understand if e-cigarettes have the potential to be used for harm-reduction perioperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults (age \\>18)\n* any gender\n* scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical Center (SFVAMC)\n* daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in the last 7 days\n* presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively\n\nExclusion Criteria:\n\n* emergency surgery (booked \\<24 hours preoperatively)\n* consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or marijuana only\n* already enrolled in a smoking cessation trial\n* current smoking cessation pharmacotherapy\n* daily user of e-cigarettes\n* previous adverse reaction to e-cigarette or transdermal nicotine\n* poor proficiency of English language¸as indicated by need for an interpreter (including family members) at the preadmission visit\n* lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by consent for surgery and other medical procedures being obtained from a substitute decision maker\n* pregnant or breastfeeding\n* unstable cardiac condition (unstable angina, unstable arrhythmia)'}, 'identificationModule': {'nctId': 'NCT02482233', 'briefTitle': 'The END Perioperative Smoking Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"', 'orgStudyIdInfo': {'id': '14-15274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ENDD', 'description': '6-week supply of disposable "NJOY" ENDDs (e-cigarettes)\n\n* the number of e-cigarettes will be determined by equating the number of e-cigarettes to the number of cigarettes smoked per day (1 pack per day = 2 e-cigarettes per day = 14 e-cigarettes/week)\n* veterans will be given detailed instructions for use and also instructed to start with the high nicotine content (4.5%) strength for three weeks, then decrease to the low nicotine content (2.4%) for two weeks, then switch to nicotine-free for the final week\n\nBoth groups will receive:\n\ni) referral to the California Smokers\' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery', 'interventionNames': ['Behavioral: ENDD (NJOY)', 'Behavioral: telephone counseling', 'Behavioral: brief advice', 'Behavioral: brochure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NRT (NicoDerm CQ)', 'description': "A prescription for 6 weeks of transdermal nicotine replacement (on-formulary at the VA) in the following doses: For smokers of 10 cigarettes per day or more, a 3-week supply of 21 mg/d, 1-week supply of 14 mg/d, 1-week supply of 7 mg/d, and 1-week of 0mg/d. Smokers of \\<10 cigarettes per day, 3 weeks of 14 mg/d patches 2 weeks of 7 mg/d patches, and 1-week of 0mg/d.\n\nBoth groups will receive:\n\ni) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery", 'interventionNames': ['Drug: NRT (NicoDerm CQ)', 'Behavioral: telephone counseling', 'Behavioral: brief advice', 'Behavioral: brochure']}], 'interventions': [{'name': 'ENDD (NJOY)', 'type': 'BEHAVIORAL', 'otherNames': ['electronic nicotine delivery device', 'NJOY e-cigarettes'], 'description': 'As described above.', 'armGroupLabels': ['ENDD']}, {'name': 'NRT (NicoDerm CQ)', 'type': 'DRUG', 'otherNames': ['nicotine patch'], 'description': 'As described above.', 'armGroupLabels': ['NRT (NicoDerm CQ)']}, {'name': 'telephone counseling', 'type': 'BEHAVIORAL', 'description': "Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.", 'armGroupLabels': ['ENDD', 'NRT (NicoDerm CQ)']}, {'name': 'brief advice', 'type': 'BEHAVIORAL', 'description': 'Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There\'s evidence that the longer you quit before your surgery, the fewer complications you\'ll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."', 'armGroupLabels': ['ENDD', 'NRT (NicoDerm CQ)']}, {'name': 'brochure', 'type': 'BEHAVIORAL', 'description': 'A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.\n\nAvailable free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure\\_%20For%20Posting.pdf', 'armGroupLabels': ['ENDD', 'NRT (NicoDerm CQ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Susan M Lee, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF / SFVAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}