Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-27 @ 11:06 AM
Study NCT ID:
NCT03612804
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2018-07-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000074264', 'term': 'Smoking Reduction'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Steven.Zeliadt@va.gov', 'phone': '206-277-4175', 'title': 'Steven B Zeliadt', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'We originally planned to base our smoking cessation outcome on biochemically-confirmed 7-day smoking abstinence. Due to the COVID-19 pandemic, it was not possible to perform the saliva cotinine testing needed for biochemically confirmed abstinence, and no biochemical data were collected. Instead, we updated our study protocol to use a combination of survey and electronic medical record data to determine smoking status at 12 months post-lung cancer screening as our primary outcome.'}}, 'adverseEventsModule': {'timeFrame': '1 year following LCS date', 'description': 'All-cause mortality during the 1 year period following LCS was assessed for all patients (providers not assessed). Serious and other non-serious adverse events were not assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Unstructured Care: Providers', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.\n\nPatients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 422, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Proactive Care: Providers', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nUnsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.\n\nPatients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nUnsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 406, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nUnsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.64', 'pValueComment': 'P-value not adjusted for multiple comparisons. A priori threshold for statistical significance was 0.05.', 'estimateComment': 'Proactive care arm represents numerator of odds ratio, unstructured care arm represents denominator of odds ratio.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with random intercept for provider and main effect term for study site.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months after lung cancer screening visit', 'description': 'The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with complete outcome data. The overall number of participants analyzed is lower than enrolled participants due to missing survey/electronic medical records data.'}, {'type': 'SECONDARY', 'title': 'Cost of Smoking Cessation Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '159.1', 'groupId': 'OG000'}, {'value': '384.2', 'spread': '161.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time period from lung cancer screening through 12 months after lung cancer screening', 'description': 'Costs of implementing smoking cessation care from lung cancer screening to 12 months post-lung cancer screening will be monitored in both the unstructured and proactive care arms. Cost of implementing smoking cessation care is defined as the sum of the cost of behavioral counseling, cost of pharmacotherapies, and cost of intervention staff effort. This measure only applies to patient enrollees.', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patients' Experience With Telephone Counseling", 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after lung cancer screening visit', 'description': 'Binary variable for whether participant reported being either very satisfied or somewhat satisfied with VA Quitline telephone counseling. This measure only applies to patient enrollees in the proactive arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of participants in the Proactive Care arm who responded to the 3 month survey and rated their satisfaction with VA Quitline telephone counseling.'}, {'type': 'SECONDARY', 'title': "Patients' Motivational Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '7.54', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '7.95', 'spread': '3.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after lung cancer screening visit', 'description': 'Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of overall sample who responded to the 3 month survey and rated their motivation to quit smoking.'}, {'type': 'SECONDARY', 'title': "Patients' Perception of Susceptibility to Harm", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after lung cancer screening visit', 'description': "Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective. Patients were asked 5 questions related to smoking and screening, and an overall score based on the sum of correct answers was calculated. Scores range from 0-5 (higher scores indicate greater knowledge about harmful effects of smoking and benefits of screening). This measure only applies to patient enrollees.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of overall sample who responded to the 3 month survey and rated their perceived susceptibility to the harmful effects of smoking and perception of screening as protective.'}, {'type': 'SECONDARY', 'title': "Patients' Self-efficacy Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nUnsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after lung cancer screening visit', 'description': "Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of overall sample who responded to the 3 month survey and rated their self-efficacy for quitting smoking.'}, {'type': 'SECONDARY', 'title': "Patients' Motivational Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '7.48', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after lung cancer screening visit', 'description': 'Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of overall sample who responded to the 12 month survey and rated their motivation to quit smoking.'}, {'type': 'SECONDARY', 'title': "Patients' Self-efficacy Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'OG001', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after lung cancer screening visit', 'description': "Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of overall sample who responded to the 12 month survey and rated their self-efficacy for quitting smoking.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unstructured Care: Providers', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.\n\nPatients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm.'}, {'id': 'FG001', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'FG002', 'title': 'Proactive Care: Providers', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.\n\nPatients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm."}, {'id': 'FG003', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nNote to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '422'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '406'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '412'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '378'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Medication copay coverage issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Not current smoker at time of screening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Non-veteran status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Misassignment to a proactive arm provider', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Provider retired from VA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Provider involved with study activities', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "This was a cluster-randomized trial in which providers were randomized to one of two care arms. Patient participants were assigned to an arm based on their provider's care assignment.", 'preAssignmentDetails': '142 providers and 3,503 patients were screened for eligibility. 26 providers were excluded (19 opt-out before enrolling any patients, 7 not primary care providers) and 2,675 patients were excluded (1,865 not meeting initial inclusion/exclusion criteria, 366 no show to LCS, 178 CT scan not LCS, 130 lung-RADS 4, 87 no copay coverage, 9 provider retired/withdrawn before LCS, 40 no local coordinator to enter notes/COVID complications).\n\n116 providers and 828 patients were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '906', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Unstructured Care: Providers', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.\n\nPatients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm.'}, {'id': 'BG001', 'title': 'Unstructured Care: Patients', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'id': 'BG002', 'title': 'Proactive Care: Providers', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nUnsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.\n\nPatients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm."}, {'id': 'BG003', 'title': 'Proactive Care: Patients', 'description': "Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.\n\nUnsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.\n\nProactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '790', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '66.7', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '6.5', 'groupId': 'BG003'}, {'value': '66.7', 'spread': '6.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not collected for providers.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '790', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '393', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG003'}, {'value': '753', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected for providers.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '790', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '382', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG003'}, {'value': '718', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected for providers.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '790', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '50', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '346', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG003'}, {'value': '592', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected for providers.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '906', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '906', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-29', 'size': 585633, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-08T17:10', 'hasProtocol': True}, {'date': '2023-02-16', 'size': 407817, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-12T17:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 944}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2018-07-23', 'resultsFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-30', 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported Smoking Abstinence', 'timeFrame': '12 months after lung cancer screening visit', 'description': 'The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.'}], 'secondaryOutcomes': [{'measure': 'Cost of Smoking Cessation Care', 'timeFrame': 'Time period from lung cancer screening through 12 months after lung cancer screening', 'description': 'Costs of implementing smoking cessation care from lung cancer screening to 12 months post-lung cancer screening will be monitored in both the unstructured and proactive care arms. Cost of implementing smoking cessation care is defined as the sum of the cost of behavioral counseling, cost of pharmacotherapies, and cost of intervention staff effort. This measure only applies to patient enrollees.'}, {'measure': "Patients' Experience With Telephone Counseling", 'timeFrame': '3 months after lung cancer screening visit', 'description': 'Binary variable for whether participant reported being either very satisfied or somewhat satisfied with VA Quitline telephone counseling. This measure only applies to patient enrollees in the proactive arm.'}, {'measure': "Patients' Motivational Assessment", 'timeFrame': '3 months after lung cancer screening visit', 'description': 'Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.'}, {'measure': "Patients' Perception of Susceptibility to Harm", 'timeFrame': '3 months after lung cancer screening visit', 'description': "Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective. Patients were asked 5 questions related to smoking and screening, and an overall score based on the sum of correct answers was calculated. Scores range from 0-5 (higher scores indicate greater knowledge about harmful effects of smoking and benefits of screening). This measure only applies to patient enrollees."}, {'measure': "Patients' Self-efficacy Assessment", 'timeFrame': '3 months after lung cancer screening visit', 'description': "Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees."}, {'measure': "Patients' Motivational Assessment", 'timeFrame': '12 months after lung cancer screening visit', 'description': 'Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.'}, {'measure': "Patients' Self-efficacy Assessment", 'timeFrame': '12 months after lung cancer screening visit', 'description': "Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'lung cancer screening', 'telephone counseling', 'quitline'], 'conditions': ['Smoking Reduction', 'Tobacco Use', 'Tobacco Smoking', 'Tomography', 'Lung Diseases', 'Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.', 'detailedDescription': 'This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Providers who schedule patients for a lung cancer screening at either of the two VA sites.\n* Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.\n\nExclusion Criteria:\n\n* Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded.\n* Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded.\n* Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded.\n* Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.'}, 'identificationModule': {'nctId': 'NCT03612804', 'acronym': 'PROACT', 'briefTitle': 'Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment', 'orgStudyIdInfo': {'id': 'IIR 16-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Unstructured care', 'description': 'Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.'}, {'type': 'EXPERIMENTAL', 'label': 'Proactive care', 'description': 'Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.', 'interventionNames': ['Behavioral: Unsigned note to provider about cessation medication prescription', 'Behavioral: Proactive Telephone Counseling from VA Quitline']}], 'interventions': [{'name': 'Unsigned note to provider about cessation medication prescription', 'type': 'BEHAVIORAL', 'description': "For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.", 'armGroupLabels': ['Proactive care']}, {'name': 'Proactive Telephone Counseling from VA Quitline', 'type': 'BEHAVIORAL', 'description': 'Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.', 'armGroupLabels': ['Proactive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010-5011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '02908-4734', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VA Medical Center, Providence, RI', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '98108-1532', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Steven B Zeliadt, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'De-identified final datasets will be made available through publisher portals or other repositories identified by SCALE collaboration for ensuring dissemination and publication of trial findings upon completion of the study (2022). Preliminary (de-identified) datasets, study protocol, and statistical analysis plans may be made available to other researchers in the SCALE collaboration throughout the duration of the project.', 'ipdSharing': 'YES', 'description': 'The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.', 'accessCriteria': 'Access will only be provided as necessary to allow transparency and evaluation of the results originally obtained by the Principal Investigator who generated the data or to expand upon the work. This assumes the recipient has knowledge, training and resources to adequately design and conduct the studies replicating the original work, or can otherwise determine the validity of results by reviewing the data provided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}