Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04020718
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2019-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gkruse@mgh.harvard.edu', 'phone': '6177243157', 'title': 'Dr. Gina Kruse', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Early Assessment Non-responder NRT', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Early Assessment Non-responder NRT Plus Coaching', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Early Assessment Responder', 'description': 'Reported 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Late Assessment Non-responder NRT', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Late Assessment Non-responder NRT Plus Coaching', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.", 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccup', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'notes': 'mild anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG001', 'title': 'Early Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG002', 'title': 'Early Assessment Responder', 'description': 'Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages'}, {'id': 'OG003', 'title': 'Late Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG004', 'title': 'Late Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG005', 'title': 'Late Assessment Responder', 'description': 'Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.'}], 'classes': [{'title': '0-abstinent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '1-smoking', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks post-randomization', 'description': '7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Excluding n=2 withdrawn, n=3 LTFU'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG001', 'title': 'Early Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG002', 'title': 'Early Assessment Responder', 'description': 'Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continued text messages.'}, {'id': 'OG003', 'title': 'Late Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG004', 'title': 'Late Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG005', 'title': 'Late Assessment Responder', 'description': 'Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continued text messages'}], 'classes': [{'title': '0-abstinent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '1-smoking', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks post-randomization', 'description': '7-day point prevalence abstinence (0, abstinent; 1, smoking)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants in the late assessment group reported 7 day abstinence (all reported continued smoking) at the 8 week time point.'}, {'type': 'SECONDARY', 'title': 'Exhaled Carbon Monoxide Less Than 8 Parts Per Million', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG001', 'title': 'Early Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG002', 'title': 'Early Assessment Responder', 'description': 'Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continued text messages.'}, {'id': 'OG003', 'title': 'Late Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG004', 'title': 'Late Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG005', 'title': 'Late Assessment Responder', 'description': 'Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.'}], 'classes': [{'title': '0-no biochemically verified abstinence', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '1-biochemically verified abstinence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks post-randomization', 'description': 'Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no participants in the late assessment group who reported 7 day abstinence at the 8 week assessment.'}, {'type': 'SECONDARY', 'title': 'Self-reported Number of Days Nicotine Lozenge and/or Patch Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mailed 4-week Supply of Combination NRT', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."}, {'id': 'OG001', 'title': 'Mailed 4-week Supply of Combination NRT Plus Proactive Telephone Coaching', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post-randomization', 'description': 'Number of days when patch and/or lozenge was used', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis compares those randomized to NRT in the second period with those randomized to NRT plus coaching in the second period, pooling early and late assessment arms together for this analysis. Excludes n=2 withdrawn, n=2 quit before second randomization, and n=2 LTFU before second randomization'}, {'type': 'SECONDARY', 'title': 'Self-reported Change in Average Number of Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG001', 'title': 'Early Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG002', 'title': 'Early Assessment Responder', 'description': 'Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages.'}, {'id': 'OG003', 'title': 'Late Assessment Non-responder NRT', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG004', 'title': 'Late Assessment Non-responder NRT Plus Coaching', 'description': 'Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching'}, {'id': 'OG005', 'title': 'Late Assessment Responder', 'description': 'Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '9.9', 'groupId': 'OG002'}, {'value': '-12.5', 'spread': '9.3', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '7.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post-randomization', 'description': 'Self-reported change in average cigarettes smoked per day', 'unitOfMeasure': 'Cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants randomized to late assessment reported 7 day abstinence at 8 weeks post-enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early Assessment', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."}, {'id': 'FG001', 'title': 'Late Assessment', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."}, {'id': 'FG002', 'title': 'Early Assessment Non-responders NRT', 'description': 'Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching'}, {'id': 'FG003', 'title': 'Early Assessment Non-responders NRT Plus Coaching', 'description': 'Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching'}, {'id': 'FG004', 'title': 'Late Assessment Non-responders NRT', 'description': 'Individuals reporting past 7 day smoking at 8 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching'}, {'id': 'FG005', 'title': 'Late Assessment Non-responders NRT Plus Coaching', 'description': 'Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching'}, {'id': 'FG006', 'title': 'Early Assessment Responders', 'description': 'Individuals reporting past 7 day abstinence from cigarettes at 4 weeks post-enrollment, assigned to continue text messages'}, {'id': 'FG007', 'title': 'Late Assessment Responders', 'description': 'Individuals reporting past 7 day abstinence from cigarettes at 8 weeks post-enrollment, assigned to continue text messages'}], 'periods': [{'title': 'Pre-assessment and Adaptation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Post-assessment and Adaptation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Assessment', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."}, {'id': 'BG001', 'title': 'Late Assessment', 'description': "Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.\n\nBrief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.\n\nMailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.\n\nProactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '51.3', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White, Non-Hispanic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'arican American, Non-Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Mixed, Non-Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other, Non-Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time to first cigarette', 'classes': [{'title': 'After 60 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '31-60 minutes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '6-30 minutes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Within 5 minutes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ready to quit in the next 30 days', 'classes': [{'title': 'No, not ready to quit in the next 30 days', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Yes, ready to quit in the next 30 days', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-06', 'size': 403325, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-21T15:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Pilot sequential multiple assignment randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2019-07-12', 'resultsFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-14', 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks', 'timeFrame': '12 weeks post-randomization', 'description': '7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks', 'timeFrame': '8 weeks post-randomization', 'description': '7-day point prevalence abstinence (0, abstinent; 1, smoking)'}, {'measure': 'Exhaled Carbon Monoxide Less Than 8 Parts Per Million', 'timeFrame': '12 weeks post-randomization', 'description': 'Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment'}, {'measure': 'Self-reported Number of Days Nicotine Lozenge and/or Patch Used', 'timeFrame': '12 weeks post-randomization', 'description': 'Number of days when patch and/or lozenge was used'}, {'measure': 'Self-reported Change in Average Number of Cigarettes Smoked Per Day', 'timeFrame': '12 weeks post-randomization', 'description': 'Self-reported change in average cigarettes smoked per day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile health'], 'conditions': ['Tobacco Use Cessation']}, 'referencesModule': {'references': [{'pmid': '36880910', 'type': 'DERIVED', 'citation': 'Kruse GR, Joyce A, Yu L, Park ER, Neil J, Chang Y, Rigotti NA. A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke. J Subst Use Addict Treat. 2023 Feb;145:208930. doi: 10.1016/j.josat.2022.208930. Epub 2023 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years)\n* Smoking status of current smoker in structured field of electronic health record (EHR)\n* Language listed as English in EHR\n* Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)\n* PCP visit in the past 2 years\n* Mobile telephone number listed in EHR\n\nExclusion Criteria:\n\n* Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking\n* Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.\n* Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.\n* Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs\n* Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation\n* Ever had an allergy to nicotine patch\n* Weight \\< 100 pounds\n* Unstable coronary disease\n* Unstable arrhythmia\n* Dementia or active psychosis or schizoaffective disorder\n* Willing and able to receive and participate with a text message program for up to 12 weeks\n* Unable to read English or unable to write English'}, 'identificationModule': {'nctId': 'NCT04020718', 'briefTitle': 'Engagement With an Adaptive Mobile Health Smoking Cessation Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Engagement With an Adaptive Mobile Health Smoking Cessation Intervention', 'orgStudyIdInfo': {'id': '2019A005710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early assessment', 'description': 'Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.', 'interventionNames': ['Behavioral: Brief telephone advice plus tailored text messages', 'Drug: Mailed nicotine replacement therapy', 'Behavioral: Proactive telephone coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Late assessment', 'description': 'Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.', 'interventionNames': ['Behavioral: Brief telephone advice plus tailored text messages', 'Drug: Mailed nicotine replacement therapy', 'Behavioral: Proactive telephone coaching']}], 'interventions': [{'name': 'Brief telephone advice plus tailored text messages', 'type': 'BEHAVIORAL', 'description': "All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.", 'armGroupLabels': ['Early assessment', 'Late assessment']}, {'name': 'Mailed nicotine replacement therapy', 'type': 'DRUG', 'description': 'Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).', 'armGroupLabels': ['Early assessment', 'Late assessment']}, {'name': 'Proactive telephone coaching', 'type': 'BEHAVIORAL', 'description': "Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.", 'armGroupLabels': ['Early assessment', 'Late assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massacusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gina R Kruse, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gina Kruse', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}