Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT03808818
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eatrials@jimmy.harvard.edu', 'phone': '617-632-3012', 'title': 'Study Statistician', 'organization': 'ECOG-ACRIN Statistical Office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'from randomization up to 1 year', 'description': 'Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 13, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Virtual Counseling (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'deathsNumAffected': 10, 'seriousNumAffected': 10}], 'seriousEvents': [{'term': 'Death, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE4.0'}, {'term': 'Other', 'notes': 'Other Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE4.0'}, {'term': 'Disease progression', 'notes': 'Death, Renal Cell Carcinoma disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE4.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'timeFrame': 'At 6 months', 'description': 'We will define 7-day point-prevalence by saliva cotinine (\\< 15 ng/ml) or expired air CO (\\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker.\n\nCOVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 restrictions saliva and CO samples could not be collected. Biochemical outcome data is not available for analysis.'}, {'type': 'SECONDARY', 'title': 'Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'timeFrame': 'At 3 months', 'description': 'We will define 7-day point-prevalence by saliva cotinine (\\< 15 ng/ml) or expired air CO (\\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker.\n\nCOVID-19 restrictions prevented any saliva or CO sample collection or analysis as part of this study. Therefore, no biochemical outcome results are available for reporting for this aim.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 restrictions saliva and CO samples could not be collected. Biochemical outcome data is not available for analysis.'}, {'type': 'SECONDARY', 'title': '7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.28', 'ciUpperLimit': '4.13', 'pValueComment': 'No correction for multiple comparisons', 'groupDescription': 'For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.\n\nThe primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'the smallest detectable difference will be 22%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months', 'description': '7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.'}, {'type': 'SECONDARY', 'title': '7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '1.04', 'ciUpperLimit': '3.33', 'groupDescription': '7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'the smallest detectable difference will be 22% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 28%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3 months', 'description': '7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.'}, {'type': 'SECONDARY', 'title': 'Self-reported Continuous Tobacco Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'the smallest detectable difference will be 21% with 80% power and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3months and 6 months', 'description': 'Continued cessation of cigarette use was analyzed by comparing 3- and 6-month 7-day point prevalence in smoking cessation.\n\nIf participants withdrew or did not answer the survey, they were marked as having recently smoked. Thus, participants needed to complete the survey and indicate that they had stopped tobacco use at both 3- and 6-month timepoints to be identified as having continuous cessation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'If participants withdrew or did not answer the survey at the specified timepoint, they were marked as having recently smoked Analysis only includes participants having a result for the 6-month timepoint'}, {'type': 'SECONDARY', 'title': 'Sustained Tobacco Abstinence at 6 Months (Not Evaluated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'timeFrame': 'At 6 months', 'description': 'To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups.\n\nCOVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 restrictions saliva and CO samples could not be collected'}, {'type': 'SECONDARY', 'title': 'Significant Reduction in Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'no margin'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 6 months', 'description': 'Significant reduction in daily smoking from baseline to 6 months was defined as \\> 50% reduction in reported number of cigarettes per day.\n\nPatients were ask to report the average number of cigarettes smoked per day on the 6mo and baseline surveys.\n\nif Xb is the average number smoked at baseline and X6 is the average number smoked at 6 months Then the reduction was calculated as (Xb-X6)/Xb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Significant Reduction in Smoking @ 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'no margin'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 3 months', 'description': 'Significant reduction in daily smoking from baseline to 6 months was defined as \\> 50% reduction in reported number of cigarettes per day.\n\nPatients were ask to report the average number of cigarettes smoked per day on the 3mo and baseline surveys.\n\nif Xb is the average number smoked at baseline and X3 is the average number smoked at 3 months Then the reduction was calculated as (Xb-X3)/Xb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Potential Effect of Sociodemographics on Treatment Effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-06'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Potential Effect of Medical and Smoking History on Treatment Effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Potential Effect of Cancer Variables on Treatment Effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-06'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Implementation of the Intervention at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': "Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability).", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Acceptability (Satisfaction With Content/Delivery) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Adoption (Program Uptake) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Appropriateness (Relevance) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Cost at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Fidelity/Adaptation at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Penetration (Reach) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Sustainability at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-06'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability: Needs Were Met', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Virtual Counseling (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'title': 'None of my needs have been met', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Only a few of my needs have been met', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Most of my needs have been met', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Almost all of my needs have been met', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Skipped question', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Alpha level 0.01', 'groupDescription': "Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'No equivalence margin'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "To what extent has the Smoke Free Support Study program met your needs?" acceptability question on the 6-month questionnaire rating from 1 (None of my needs have been met) to 4 (Almost all of my needs have been met) with higher scores indicating more needs met.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability: Assistance Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced Usual Care patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'categories': [{'title': 'No, definitely not', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No, not really', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Yes, generally', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Yes, definitely', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Alpha level 0.01', 'groupDescription': "Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'No equivalence margin'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "Did you get the kind of smoking cessation assistance that you wanted?" acceptability question on the 6-month questionnaire rating from 1 (No, definitely not) to 4 (Yes, definitely) with higher scores indicating greater confidence that assistance met desired level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients answering the acceptability question are reported'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability: Helpfulness of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Virtual Counseling (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'title': 'Not at all helpful', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Not very helpful', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neutral', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat helpful', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Very helpful', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Alpha level 0.01', 'groupDescription': "Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'No equivalence margin'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "How helpful has the Smoke Free Support Study been for you?" acceptability question on the 6-month questionnaire rating from 1 (Not at all helpful) to 5 (Very helpful) with higher scores indicating increased helpfulness.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability: Quality of Assistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Virtual Counseling (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'title': 'Did not answer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "How would you rate the quality of the smoking cessation assistance that you received?" acceptability question on the 6-month questionnaire rating from 1 (Poor) to 4 (Excellent) with higher scores indicating more greater quality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability: Would Recommend Study to Friends', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Virtual Counseling (Virtual Counseling Sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'classes': [{'title': 'No, definitely not', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': "No, I don't think so", 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Yes, I think so', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Yes, definitely', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Did Not Answer', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Alpha level 0.01', 'groupDescription': "Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'No equivalence margin'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "If a friend were in need of similar help, would you recommend the Smoke Free Support Study to him or her?" acceptability question on the 6-month questionnaire Ratings from 1 (No, definitely not) to 4 (Yes, definitely) with higher scores indicating more greater likelihood of recommending.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'FG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both)\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'Baseline Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': '3 Month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': '7-day Point Prevalence @3mo (Value or Imputed)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': '6 Month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': '7-day Point Prevalence @6mo (Value or Imputed)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}]}], 'recruitmentDetails': 'patients recruited between April 2019 and December 2022'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EUC (Smoking Assessment, Quitting Advice, Quitline Referral)', 'description': 'Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.\n\nBehavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies'}, {'id': 'BG001', 'title': 'VST (Virtual Counseling Sessions, NRT)', 'description': 'Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).\n\nNicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling\n\nSurvey Administration: Ancillary studies\n\nTobacco Cessation Counseling: Receive virtual tobacco cessation counseling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '81'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '77'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', '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': '1', 'groupId': 'BG001'}, {'value': '2', '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': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '264', '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': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living with a smoker', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-01', 'size': 935158, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-12T16:46', 'hasProtocol': True}, {'date': '2021-07-01', 'size': 228392, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-12T16:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2019-01-08', 'resultsFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-10', 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Potential Effect of Sociodemographics on Treatment Effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.'}, {'measure': 'Potential Effect of Medical and Smoking History on Treatment Effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.'}, {'measure': 'Potential Effect of Cancer Variables on Treatment Effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.'}, {'measure': 'Implementation of the Intervention at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': "Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability)."}, {'measure': 'Intervention Acceptability (Satisfaction With Content/Delivery) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Intervention Adoption (Program Uptake) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Intervention Appropriateness (Relevance) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Intervention Cost at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Treatment Fidelity/Adaptation at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Intervention Penetration (Reach) at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Intervention Sustainability at Community Oncology Sites', 'timeFrame': 'Up to 36 months', 'description': 'Outcome will be assessed with mixed methods using qualitative \\& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.'}, {'measure': 'Acceptability: Needs Were Met', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "To what extent has the Smoke Free Support Study program met your needs?" acceptability question on the 6-month questionnaire rating from 1 (None of my needs have been met) to 4 (Almost all of my needs have been met) with higher scores indicating more needs met.'}, {'measure': 'Acceptability: Assistance Support', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "Did you get the kind of smoking cessation assistance that you wanted?" acceptability question on the 6-month questionnaire rating from 1 (No, definitely not) to 4 (Yes, definitely) with higher scores indicating greater confidence that assistance met desired level.'}, {'measure': 'Acceptability: Helpfulness of Study', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "How helpful has the Smoke Free Support Study been for you?" acceptability question on the 6-month questionnaire rating from 1 (Not at all helpful) to 5 (Very helpful) with higher scores indicating increased helpfulness.'}, {'measure': 'Acceptability: Quality of Assistance', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "How would you rate the quality of the smoking cessation assistance that you received?" acceptability question on the 6-month questionnaire rating from 1 (Poor) to 4 (Excellent) with higher scores indicating more greater quality'}, {'measure': 'Acceptability: Would Recommend Study to Friends', 'timeFrame': '6-months', 'description': 'Guided by Proctor and colleagues\' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process.\n\nResults of the responses to the "If a friend were in need of similar help, would you recommend the Smoke Free Support Study to him or her?" acceptability question on the 6-month questionnaire Ratings from 1 (No, definitely not) to 4 (Yes, definitely) with higher scores indicating more greater likelihood of recommending.'}], 'primaryOutcomes': [{'measure': 'Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)', 'timeFrame': 'At 6 months', 'description': 'We will define 7-day point-prevalence by saliva cotinine (\\< 15 ng/ml) or expired air CO (\\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker.\n\nCOVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.'}], 'secondaryOutcomes': [{'measure': 'Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)', 'timeFrame': 'At 3 months', 'description': 'We will define 7-day point-prevalence by saliva cotinine (\\< 15 ng/ml) or expired air CO (\\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker.\n\nCOVID-19 restrictions prevented any saliva or CO sample collection or analysis as part of this study. Therefore, no biochemical outcome results are available for reporting for this aim.'}, {'measure': '7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report', 'timeFrame': 'At 6 months', 'description': '7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.'}, {'measure': '7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report', 'timeFrame': 'At 3 months', 'description': '7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.'}, {'measure': 'Self-reported Continuous Tobacco Abstinence', 'timeFrame': 'At 3months and 6 months', 'description': 'Continued cessation of cigarette use was analyzed by comparing 3- and 6-month 7-day point prevalence in smoking cessation.\n\nIf participants withdrew or did not answer the survey, they were marked as having recently smoked. Thus, participants needed to complete the survey and indicate that they had stopped tobacco use at both 3- and 6-month timepoints to be identified as having continuous cessation.'}, {'measure': 'Sustained Tobacco Abstinence at 6 Months (Not Evaluated)', 'timeFrame': 'At 6 months', 'description': 'To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups.\n\nCOVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.'}, {'measure': 'Significant Reduction in Smoking', 'timeFrame': 'baseline and 6 months', 'description': 'Significant reduction in daily smoking from baseline to 6 months was defined as \\> 50% reduction in reported number of cigarettes per day.\n\nPatients were ask to report the average number of cigarettes smoked per day on the 6mo and baseline surveys.\n\nif Xb is the average number smoked at baseline and X6 is the average number smoked at 6 months Then the reduction was calculated as (Xb-X6)/Xb'}, {'measure': 'Significant Reduction in Smoking @ 3 Months', 'timeFrame': 'baseline and 3 months', 'description': 'Significant reduction in daily smoking from baseline to 6 months was defined as \\> 50% reduction in reported number of cigarettes per day.\n\nPatients were ask to report the average number of cigarettes smoked per day on the 3mo and baseline surveys.\n\nif Xb is the average number smoked at baseline and X3 is the average number smoked at 3 months Then the reduction was calculated as (Xb-X3)/Xb'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma In Situ', 'Current Smoker', 'Malignant Neoplasm', 'Primary Neoplasm', 'Recurrent Neoplasm', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '35841024', 'type': 'DERIVED', 'citation': 'Goshe BM, Rasmussen AW, Wagner LI, Sicks JD, Gareen IF, Carlos RC, Herman BA, Walter AW, Regan S, Levy DE, Mahon I, Muzikansky A, Neil JM, Lui M, Dilip D, Malloy L, Gonzalez I, Finkelstein-Fox L, McCann C, Perez E, Ostroff JS, Park ER. Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]. BMC Public Health. 2022 Jul 15;22(1):1359. doi: 10.1186/s12889-022-13631-w.'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment.\n\nSECONDARY OBJECTIVES:\n\nI. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.\n\nII. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.\n\nIII. Significant reduction (\\> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up.\n\nIV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months).\n\nEXPLORATORY OBJECTIVES:\n\nI. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms.\n\nII. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of the investigator's intervention at community oncology sites.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A (Enhanced Usual Care \\[EUC\\]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline.\n\nARM B (Virtual Intervention Treatment \\[VIT\\]): Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge combined or alone).\n\nAfter completion of study, patients may be followed up for 1 year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STAFF ELIGIBILITY CRITERIA:\n* Must be English speaking.\n* Must be employed at NCI Community Oncology Research Program (NCORP) site for at least three months.\n* PATIENT ELIGIBILITY CRITERIA STEP 0:\n* Patient presenting with any type of cancer with a date of diagnosis within the past 4 months. Recurrence, diagnosed within the last 4 months, of tumors in patients with past cancer diagnoses will be considered eligible. Patients with a new primary cancer, diagnosed within the last 4 months, who have been treated previously for other types of cancer will also be considered eligible. ?In situ? cancers, diagnosed within the past 4 months, will also be considered eligible.\n* Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days.\n* Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish.\n* Patient must have telephone, e-mail access, and have access to the internet with a camera-enabled device (e.g., smartphone, tablet, computer, laptop with a webcam/camera)\n\n * NOTE: The restriction to those with web and e-mail access is based on the primary intention of the study; to assess the implementation of the virtual intervention in the NCORP network.\n* ELIGIBILITY CRITERIA STEP 1: Patient must still meet all criteria outlined in step 0.\n* ELIGIBILITY STEP 2 (RANDOMIZATION): Patient must have completed baseline survey in Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes (EASEEPRO) within 1 month (30 days) of the date of informed consent (Step 1).\n\nExclusion Criteria:\n\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above, or is deemed medically unable to participate by study investigators or oncology clinician (i.e., referral to hospice).\n* Patient has no intention to receive their cancer care or monitoring at an NCORP community cancer site.'}, 'identificationModule': {'nctId': 'NCT03808818', 'briefTitle': 'Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"', 'orgStudyIdInfo': {'id': 'EAQ171CD'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02826', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'EAQ171CD', 'type': 'OTHER', 'domain': 'ECOG-ACRIN Cancer Research Group'}, {'id': 'ECOG-ACRIN-EAQ171CD', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'EAQ171CD', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'R01CA214427', 'link': 'https://reporter.nih.gov/quickSearch/R01CA214427', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A (smoking assessment, quitting advice, Quitline referral)', 'description': 'Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.', 'interventionNames': ['Other: Behavioral, Psychological or Informational Intervention', 'Other: Quality-of-Life Assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (virtual counseling sessions, NRT)', 'description': 'Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).', 'interventionNames': ['Drug: Nicotine Replacement', 'Other: Quality-of-Life Assessment', 'Other: Survey Administration', 'Other: Tobacco Cessation Counseling']}], 'interventions': [{'name': 'Behavioral, Psychological or Informational Intervention', 'type': 'OTHER', 'description': 'Receive information about tobacco cessation', 'armGroupLabels': ['Arm A (smoking assessment, quitting advice, Quitline referral)']}, {'name': 'Nicotine Replacement', 'type': 'DRUG', 'otherNames': ['Nicotine Replacement Therapy', 'NRT'], 'description': 'Given NRT patch or lozenge (or both)', 'armGroupLabels': ['Arm B (virtual counseling sessions, NRT)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (smoking assessment, quitting advice, Quitline referral)', 'Arm B (virtual counseling sessions, NRT)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm B (virtual counseling sessions, NRT)']}, {'name': 'Tobacco Cessation Counseling', 'type': 'OTHER', 'description': 'Receive virtual tobacco cessation counseling', 'armGroupLabels': ['Arm B (virtual counseling sessions, NRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Women's Cancer Care", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Katmai Oncology Group', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '61832', 'city': 'Danville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle on Vermilion', 'geoPoint': {'lat': 40.12448, 'lon': -87.63002}}, {'zip': '62864', 'city': 'Mount Vernon', 'state': 'Illinois', 'country': 'United States', 'facility': 'Good Samaritan Regional Health Center', 'geoPoint': {'lat': 38.31727, 'lon': -88.90312}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '52402', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': "Physicians' Clinic of Iowa PC", 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Methodist Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Oncology and Hematology Associates-Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Unity Hospital', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '38671', 'city': 'Southhaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Baptist Memorial Hospital and Cancer Center-Desoto', 'geoPoint': {'lat': 34.99176, 'lon': -90.12759}}, {'zip': '64804', 'city': 'Joplin', 'state': 'Missouri', 'country': 'United States', 'facility': 'Freeman Health System', 'geoPoint': {'lat': 37.08423, 'lon': -94.51328}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Heartland Regional Medical Center', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CoxHealth South Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Moses Campus', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CaroMont Regional Medical Center', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '28791', 'city': 'Hendersonville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Margaret R Pardee Memorial Hospital', 'geoPoint': {'lat': 35.31873, 'lon': -82.46095}}, {'zip': '45714', 'city': 'Belpre', 'state': 'Ohio', 'country': 'United States', 'facility': 'Strecker Cancer Center-Belpre', 'geoPoint': {'lat': 39.27396, 'lon': -81.5729}}, {'zip': '45750', 'city': 'Marietta', 'state': 'Ohio', 'country': 'United States', 'facility': 'Marietta Memorial Hospital', 'geoPoint': {'lat': 39.41535, 'lon': -81.45484}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'OhioHealth Marion General Hospital', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '45662', 'city': 'Portsmouth', 'state': 'Ohio', 'country': 'United States', 'facility': 'Southern Ohio Medical Center', 'geoPoint': {'lat': 38.73174, 'lon': -82.99767}}, {'zip': '29640', 'city': 'Easley', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Easley', 'geoPoint': {'lat': 34.82984, 'lon': -82.60152}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Butternut', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Faris', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Eastside', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29650', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Greer', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29672', 'city': 'Seneca', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Seneca', 'geoPoint': {'lat': 34.68566, 'lon': -82.9532}}, {'zip': '29307', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Spartanburg', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial Hospital and Cancer Center-Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial Hospital for Women', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '98001', 'city': 'Auburn', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Auburn Medical Center', 'geoPoint': {'lat': 47.30732, 'lon': -122.22845}}, {'zip': '98335', 'city': 'Gig Harbor', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Gig Harbor Medical Park', 'geoPoint': {'lat': 47.32926, 'lon': -122.58013}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Good Samaritan Hospital', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Tacoma General Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '54911', 'city': 'Appleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'ThedaCare Regional Cancer Center', 'geoPoint': {'lat': 44.26193, 'lon': -88.41538}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Saint Vincent Hospital Cancer Center Green Bay', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Saint Vincent Hospital Cancer Center at Saint Mary's", 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54311', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora BayCare Medical Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54154', 'city': 'Oconto Falls', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Saint Vincent Hospital Cancer Center at Oconto Falls', 'geoPoint': {'lat': 44.87388, 'lon': -88.14288}}, {'zip': '53081', 'city': 'Sheboygan', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'HSHS Saint Nicholas Hospital', 'geoPoint': {'lat': 43.75083, 'lon': -87.71453}}, {'zip': '54235-1495', 'city': 'Sturgeon Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Saint Vincent Hospital Cancer Center at Sturgeon Bay', 'geoPoint': {'lat': 44.83416, 'lon': -87.37704}}], 'overallOfficials': [{'name': 'Elyse Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ECOG-ACRIN Cancer Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ECOG-ACRIN Cancer Research Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}