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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early assessment | Experimental | 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. |
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| Late assessment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief telephone advice plus tailored text messages | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?" | 12 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 7-day point prevalence abstinence (0, abstinent; 1, smoking) | 8 weeks post-randomization |
| Exhaled Carbon Monoxide Less Than 8 Parts Per Million |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina R Kruse, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massacusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36880910 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Assessment | 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. Brief 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. Mailed 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. Proactive 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. |
| FG001 | Late Assessment | 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. Brief 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. Mailed 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. Proactive 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. |
| FG002 | Early Assessment Non-responders NRT | 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 |
| FG003 | Early Assessment Non-responders NRT Plus Coaching | 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 |
| FG004 | Late Assessment Non-responders NRT | 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 |
| FG005 | Late Assessment Non-responders NRT Plus Coaching | 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 |
| FG006 | Early Assessment Responders | Individuals reporting past 7 day abstinence from cigarettes at 4 weeks post-enrollment, assigned to continue text messages |
| FG007 | Late Assessment Responders | Individuals reporting past 7 day abstinence from cigarettes at 8 weeks post-enrollment, assigned to continue text messages |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-assessment and Adaptation |
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| Post-assessment and Adaptation |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Assessment | 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. Brief 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. Mailed 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. Proactive 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?" | Excluding n=2 withdrawn, n=3 LTFU | Posted | Count of Participants | Participants | 12 weeks post-randomization |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Assessment Non-responder NRT | 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. Brief 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. Mailed 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. Proactive 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gina Kruse | Massachusetts General Hospital | 6177243157 | gkruse@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2020 | Jan 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Pilot sequential multiple assignment randomized trial
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| Mailed nicotine replacement therapy | Drug | 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). |
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| Proactive telephone coaching | Behavioral | 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. |
|
Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment
| 12 weeks post-randomization |
| Self-reported Number of Days Nicotine Lozenge and/or Patch Used | Number of days when patch and/or lozenge was used | 12 weeks post-randomization |
| Self-reported Change in Average Number of Cigarettes Smoked Per Day | Self-reported change in average cigarettes smoked per day | 12 weeks post-randomization |
| COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Late Assessment | 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. Brief 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. Mailed 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. Proactive 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Time to first cigarette | Count of Participants | Participants |
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| Ready to quit in the next 30 days | Count of Participants | Participants |
|
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
| OG002 | Early Assessment Responder | Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages |
| OG003 | Late Assessment Non-responder NRT | 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 |
| OG004 | Late Assessment Non-responder NRT Plus Coaching | 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 |
| OG005 | Late Assessment Responder | Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages. |
|
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| Secondary | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 7-day point prevalence abstinence (0, abstinent; 1, smoking) | No participants in the late assessment group reported 7 day abstinence (all reported continued smoking) at the 8 week time point. | Posted | Count of Participants | Participants | 8 weeks post-randomization |
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| Secondary | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment | There were no participants in the late assessment group who reported 7 day abstinence at the 8 week assessment. | Posted | Count of Participants | Participants | 12 weeks post-randomization |
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| Secondary | Self-reported Number of Days Nicotine Lozenge and/or Patch Used | Number of days when patch and/or lozenge was used | 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 | Posted | Mean | Standard Deviation | Days | 12 weeks post-randomization |
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| Secondary | Self-reported Change in Average Number of Cigarettes Smoked Per Day | Self-reported change in average cigarettes smoked per day | No participants randomized to late assessment reported 7 day abstinence at 8 weeks post-enrollment. | Posted | Mean | Standard Deviation | Cigarettes per day | 12 weeks post-randomization |
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Early Assessment Non-responder NRT Plus Coaching | 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. Brief 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. Mailed 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. Proactive 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. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | Early Assessment Responder | Reported 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Late Assessment Non-responder NRT | 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. Brief 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. Mailed 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. Proactive 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. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | Late Assessment Non-responder NRT Plus Coaching | 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. Brief 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. Mailed 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. Proactive 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. | 0 | 7 | 0 | 7 | 1 | 7 |
| Hiccup | Gastrointestinal disorders | Non-systematic Assessment |
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| indigestion | Gastrointestinal disorders | Non-systematic Assessment |
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| anxiety | Psychiatric disorders | Non-systematic Assessment | mild anxiety |
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| 1-smoking |
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| 1-biochemically verified abstinence |
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