Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-07 @ 4:01 AM
Study NCT ID:
NCT02730260
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Worksite Phone Counseling for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wsumner@dom.wustl.edu', 'phone': '314-454-8164', 'title': 'Dr. Walton Sumner', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years, 5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Directive', 'description': 'Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nDirective smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.', 'otherNumAtRisk': 258, 'otherNumAffected': 0, 'seriousNumAtRisk': 258, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nondirective', 'description': 'Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nNondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.', 'otherNumAtRisk': 260, 'otherNumAffected': 0, 'seriousNumAtRisk': 260, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Abstinence for 7 Days at Last Contact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Directive', 'description': 'Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nDirective smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.'}, {'id': 'OG001', 'title': 'Nondirective', 'description': 'Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nNondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.8', 'groupDescription': 'Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.6', 'groupDescription': 'Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6-12 months', 'description': 'By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Directive', 'description': 'Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nDirective smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.'}, {'id': 'FG001', 'title': 'Nondirective', 'description': 'Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nNondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}, {'groupId': 'FG001', 'numSubjects': '260'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '75'}]}]}], 'preAssignmentDetails': '978 persons inquired about the program. 847 took steps to qualify for an employer health insurance discount Of these, 294 declined to enroll, e.g. for being in the precontemplative stage of change.\n\n553 persons participated in coaching. Of these, 35 worked with coaches in training. 518 participants enrolled in the randomized trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Directive', 'description': 'Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nDirective smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.'}, {'id': 'BG001', 'title': 'Nondirective', 'description': 'Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.\n\nNondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '46.0', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Income', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Income levels are:\n\n1. $0-$15,000\n2. \\>$15,000-$30,000\n3. \\>$30,000-$45,000\n4. \\>$45,000-$60,000\n5. \\>$60,000-$75,000\n6. \\>$75,000-$90,000\n7. \\>$90,000', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Education', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'description': "The education scale is:\n\n1. Less than 9th grade\n2. 9th grade\n3. 10th grade\n4. 11th grade\n5. High school graduate or General Educational Development (GED)\n6. Some college or trade school\n7. Bachelor's degree\n8. Master's degree\n9. Doctoral degree", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fagerström Test for Nicotine Dependence (FTND)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores for 3 binary and 3 multiple choice items in the Fagerstrom Test for Nicotine Dependence are summed to yield a total score of 0-10.\n\n.\n\nClassification of dependence:\n\n0-2 Very low; 3-4 Low; 5 Moderate; 6-7 High; 8-10 Very high.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 518}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2016-03-31', 'resultsFirstSubmitDate': '2016-06-01', 'studyFirstSubmitQcDate': '2016-03-31', 'lastUpdatePostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-31', 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Abstinence for 7 Days at Last Contact', 'timeFrame': '6-12 months', 'description': 'By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Directive coaching', 'Nondirective coaching', 'smoking cessation quitline', 'social support'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '39868569', 'type': 'DERIVED', 'citation': 'Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.'}, {'pmid': '27400966', 'type': 'DERIVED', 'citation': 'Sumner W 2nd, Walker MS, Highstein GR, Fischer I, Yan Y, McQueen A, Fisher EB. A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline. BMC Public Health. 2016 Jul 11;16:550. doi: 10.1186/s12889-016-3202-y.'}]}, 'descriptionModule': {'briefSummary': 'Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.', 'detailedDescription': 'BACKGROUND Given the association of smoking with low socioeconomic status, the potential of telephone counseling for smoking cessation to reach diverse audiences needs evaluation. In addition, different approaches to counseling have not been systematically examined, and may differentially affect reach, retention, and success.\n\nPURPOSE To describe employee participation and outcomes in a trial of two counseling styles for telephone-based smoking cessation support.\n\nAPPROACH Employees and spouses of two large organizations are invited to participate in a trial of a telephone quitline. Participants are randomized to one of two coaching styles. A protocol-driven (Directive) coaching approach follows a script for each of seven calls over 9 weeks. A participant-centered (Nondirective) coaching approach allowed smokers to select topics of interest, with prompting by the coach as needed. A computer assisted telephone interview program and database provide topics in correct sequence for directive coaching, allow coaches to indicate topics during nondirective coaching, and track time spent on topics in both conditions.\n\nPREDICTOR VARIABLES Demographics, smoking history and conventional self-reported measures of nicotine dependence, smoking urges, preference for patient-centric care, and depression are collected at baseline.\n\nOUTCOMES The primary outcome measure is self-reported abstinence from smoking for 7 days at the time of last follow up, 6 or 12 months after baseline assessment.\n\nANALYSES Interactions of Race and Income with coaching approach are analyzed. Based on results with asthma patients, a positive interaction of low income with nondirective coaching is tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change\n* English speaking\n\nExclusion Criteria:\n\n* Smoker in precontemplation stage of change'}, 'identificationModule': {'nctId': 'NCT02730260', 'briefTitle': 'Worksite Phone Counseling for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Worksite Phone Counseling for Smoking Cessation', 'orgStudyIdInfo': {'id': '04-1335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Directive', 'description': 'Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.', 'interventionNames': ['Behavioral: Directive smoking cessation coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Nondirective', 'description': 'Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.', 'interventionNames': ['Behavioral: Nondirective smoking cessation coaching']}], 'interventions': [{'name': 'Nondirective smoking cessation coaching', 'type': 'BEHAVIORAL', 'description': 'Quitline coach allows participant to set agenda for each call.', 'armGroupLabels': ['Nondirective']}, {'name': 'Directive smoking cessation coaching', 'type': 'BEHAVIORAL', 'description': 'Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.', 'armGroupLabels': ['Directive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Walton Sumner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}