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| ID | Type | Description | Link |
|---|---|---|---|
| K12DA041449 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Cigarette smoking remains one of the leading causes of preventable death. Effective smoking cessation medications exist but use of these treatments is low, making it difficult for most to quit smoking. Behavioral interventions are needed to engage current smokers in the process of quitting smoking and promote the use of evidence-based cessation medications.
At the same time, genetics influences one's smoking behaviors (e.g., how much they smoke, difficulty quitting) and risk of smoking-related diseases, yet these personalized factors have not been included in existing behavioral interventions. Incorporating these individualized factors into smoking cessation interventions may make them more personally engaging and thus motivating for treatment.
This study will pilot test a risk communication tool that is personalized to one's genetics and will demonstrate the feasibility of a larger trial to test the effect of this personalized genetically-informed intervention on smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetically-Informed RiskProfile | Experimental |
| |
| Brief Cessation Advice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetically-Informed RiskProfile | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days | Participants in both groups were asked about their use of several smoking cessation medications (Question: "In the past 30 days, have you used any of the following prescription medications or over-the-counter aids to help you quit or cut back on smoking?"; Response options: 1=Bupropion or Zyban; 2=Varenicline or Chantix; 3=Nicotine patch; 4=Nicotine gum or lozenge; 5=Other (Specify). | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up |
| Change in Number of Cigarettes Smoked Per Day | Participants in both groups were asked "In the past 30 days, how many days did you smoke cigarettes" and "On the days in which you smoked cigarettes in the past month, about how many cigarettes did you smoke". The values from these questions are multiplied together and then divided by 30 (days) to calculate the number of cigarettes smoked per day for each participant. | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Readiness to Quit Smoking | Participants in both groups were assessed on self-reported stage of readiness to quit smoking. This measure includes one item based on the Transtheoretical Model of Change and measured along stages of Precontemplation, Contemplation, Preparation, and Action. (Question: ""Are you thinking of quitting smoking?""; Response options: 1=No, I am not seriously considering quitting within the next 6 months (Precontemplation); 2=Yes, I am seriously considering quitting within the next 6 months (Contemplation); 3=Yes, I am seriously planning to quit within the next 30 days (Preparation); 4=I have quit smoking within the past 6 months (Action). A higher score represents a higher stage of readiness to quit smoking. " |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex T Ramsey, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Plan to publish within 12 months of ending data collection.
The investigators will disseminate study findings through manuscripts, presentations, and lay reports. The investigators will make available via publications the steps and programs needed to implement the intervention. The investigators will make the protocols and tools available to other researchers to be used as a model template for interventions bringing genetics to the treatment of other substance use disorders.
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The study opened to participant enrollment on 02/08/2021 and closed to participant enrollment on 05/29/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genetically-Informed RiskProfile | Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change. This is a fully remote trial, with intervention delivered via video conferencing. |
| FG001 | Brief Cessation Advice | Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed. This is a fully remote trial, with brief cessation advice delivered via video conferencing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genetically-Informed RiskProfile | Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change. This is a fully remote trial, with intervention delivered via video conferencing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days | Participants in both groups were asked about their use of several smoking cessation medications (Question: "In the past 30 days, have you used any of the following prescription medications or over-the-counter aids to help you quit or cut back on smoking?"; Response options: 1=Bupropion or Zyban; 2=Varenicline or Chantix; 3=Nicotine patch; 4=Nicotine gum or lozenge; 5=Other (Specify). | Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Count of Participants | Participants | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up |
|
Adverse events were collected at baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up.
Adverse events were collected when self-reported by participants during the trial.
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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 | Genetically-Informed RiskProfile | Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change. This is a fully remote trial, with intervention delivered via video conferencing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex T. Ramsey, Ph.D. | Washington University School of Medicine | 314-362-5370 | aramsey@wustl.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 | Nov 6, 2023 | Nov 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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|
| Brief Cessation Advice | Other |
|
|
| Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up |
| Change in Perceived Disease Risk | Participants in both groups were assessed on self-reported perceptions of personal susceptibility to smoking-related diseases. This measure includes one item comprising the perceived susceptibility scale (Question: "How likely is it for you to develop a smoking-related disease such as lung cancer or chronic obstructive pulmonary disease (COPD), if you continue to smoke?"; Response options: 1=Very unlikely; 2=Somewhat unlikely; 3=Neither unlikely nor likely; 4=Somewhat likely; 5=Very likely). A higher score represents a higher perceived disease risk. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
| Change in Perceived Benefits of Cessation | Participants in both groups were assessed on self-reported perceptions of personal health benefits related to quitting smoking. This measure is based on 3 items from the Perceived Risks and Benefits Questionnaire (PRBQ) addressing benefits related to reduced risks of smoking-related diseases, avoidance of future health problems, and increased longevity if the participant were to quit smoking. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Very Unlikely to 5=Very Likely. Individual scores on the 3 items were then averaged together for a total scale range of 1 to 5. A higher score represents higher perceived benefits of cessation. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
| Change in Perceived Value of Cessation Treatments | Participants in both groups were assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking. This measure includes 4 items modified from the Beliefs and Attitudes about Buproprion Scale which assesses perceived importance of using medications for smoking cessation, perceived confidence in medications as a smoking cessation aid, general expectancy that smoking cessation medications help people stop smoking, and perceived confidence in being able to use smoking cessation medications within the next month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Extremely. Individual scores on the 4 items were then averaged together for at total scale range of 1-5. A higher score represents a higher perceived value of cessation treatment. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
| Change in Self-efficacy of Cessation | Participants in both groups were assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation. This measure is based on 3 items modified from the Skill Self-Efficacy Scale and 3 items modified from the Try Self-Efficacy Scale. Skill self-efficacy items address confidence to solicit social support, avoid situations with a high risk of relapse, and distract oneself when experiencing cravings during a quit attempt. Try self-efficacy items address perceived personal ability to smoke fewer cigarettes a day, resist smoking for one week, and resist smoking for one month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Very. Individual scores on the 3 items were then averaged together for a total scale range of 1-5. A higher score represents a higher perceived self-efficacy of cessation. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
| Personal Relevance of Intervention | Participants in both groups were assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable. This measure includes 4 items modified from the Personal Relevance Scale and addresses the extent to which the intervention helped participants learn something about themselves, the role that their personal characteristics play in their smoking, how smoking affects their life, and the impact on their smoking cessation attempts. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Strongly Disagree to 5=Strongly Agree. Individual scores on the 4 items were then averaged together for a total scale range of 1 to 5. A higher score represents a higher perception of personal relevance of the intervention. | Immediately following intervention receipt |
| BG001 | Brief Cessation Advice | Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed. This is a fully remote trial, with brief cessation advice delivered via video conferencing. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Brief Cessation Advice | Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed. This is a fully remote trial, with brief cessation advice delivered via video conferencing. |
|
|
| Primary | Change in Number of Cigarettes Smoked Per Day | Participants in both groups were asked "In the past 30 days, how many days did you smoke cigarettes" and "On the days in which you smoked cigarettes in the past month, about how many cigarettes did you smoke". The values from these questions are multiplied together and then divided by 30 (days) to calculate the number of cigarettes smoked per day for each participant. | Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Mean | Standard Deviation | cigarettes smoked per day | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up |
|
|
|
| Secondary | Change in Readiness to Quit Smoking | Participants in both groups were assessed on self-reported stage of readiness to quit smoking. This measure includes one item based on the Transtheoretical Model of Change and measured along stages of Precontemplation, Contemplation, Preparation, and Action. (Question: ""Are you thinking of quitting smoking?""; Response options: 1=No, I am not seriously considering quitting within the next 6 months (Precontemplation); 2=Yes, I am seriously considering quitting within the next 6 months (Contemplation); 3=Yes, I am seriously planning to quit within the next 30 days (Preparation); 4=I have quit smoking within the past 6 months (Action). A higher score represents a higher stage of readiness to quit smoking. " | Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Count of Participants | Participants | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up |
|
|
|
| Secondary | Change in Perceived Disease Risk | Participants in both groups were assessed on self-reported perceptions of personal susceptibility to smoking-related diseases. This measure includes one item comprising the perceived susceptibility scale (Question: "How likely is it for you to develop a smoking-related disease such as lung cancer or chronic obstructive pulmonary disease (COPD), if you continue to smoke?"; Response options: 1=Very unlikely; 2=Somewhat unlikely; 3=Neither unlikely nor likely; 4=Somewhat likely; 5=Very likely). A higher score represents a higher perceived disease risk. | Some participants did not complete assessments at baseline, immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
|
|
|
| Secondary | Change in Perceived Benefits of Cessation | Participants in both groups were assessed on self-reported perceptions of personal health benefits related to quitting smoking. This measure is based on 3 items from the Perceived Risks and Benefits Questionnaire (PRBQ) addressing benefits related to reduced risks of smoking-related diseases, avoidance of future health problems, and increased longevity if the participant were to quit smoking. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Very Unlikely to 5=Very Likely. Individual scores on the 3 items were then averaged together for a total scale range of 1 to 5. A higher score represents higher perceived benefits of cessation. | Some participants did not complete assessments at baseline, immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
|
|
|
| Secondary | Change in Perceived Value of Cessation Treatments | Participants in both groups were assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking. This measure includes 4 items modified from the Beliefs and Attitudes about Buproprion Scale which assesses perceived importance of using medications for smoking cessation, perceived confidence in medications as a smoking cessation aid, general expectancy that smoking cessation medications help people stop smoking, and perceived confidence in being able to use smoking cessation medications within the next month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Extremely. Individual scores on the 4 items were then averaged together for at total scale range of 1-5. A higher score represents a higher perceived value of cessation treatment. | Some participants did not complete assessments at immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
|
|
|
| Secondary | Change in Self-efficacy of Cessation | Participants in both groups were assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation. This measure is based on 3 items modified from the Skill Self-Efficacy Scale and 3 items modified from the Try Self-Efficacy Scale. Skill self-efficacy items address confidence to solicit social support, avoid situations with a high risk of relapse, and distract oneself when experiencing cravings during a quit attempt. Try self-efficacy items address perceived personal ability to smoke fewer cigarettes a day, resist smoking for one week, and resist smoking for one month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Very. Individual scores on the 3 items were then averaged together for a total scale range of 1-5. A higher score represents a higher perceived self-efficacy of cessation. | Some participants did not complete assessments at immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up |
|
|
|
| Secondary | Personal Relevance of Intervention | Participants in both groups were assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable. This measure includes 4 items modified from the Personal Relevance Scale and addresses the extent to which the intervention helped participants learn something about themselves, the role that their personal characteristics play in their smoking, how smoking affects their life, and the impact on their smoking cessation attempts. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Strongly Disagree to 5=Strongly Agree. Individual scores on the 4 items were then averaged together for a total scale range of 1 to 5. A higher score represents a higher perception of personal relevance of the intervention. | Some participants did not complete the assessment immediately following intervention so that is why the number of participants analyzed does not match the number of participants enrolled. | Posted | Mean | Standard Deviation | score on a scale | Immediately following intervention receipt |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 1 |
| 74 |
| EG001 | Brief Cessation Advice | Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed. This is a fully remote trial, with brief cessation advice delivered via video conferencing. | 0 | 74 | 0 | 74 | 0 | 74 |
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| D001519 | Behavior |
| Self-reported cigarettes per day at prior to intervention |
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| Self-reported cigarettes per day at 30-day follow-up |
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| Self-reported cigarettes per day at 6-month follow-up |
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| Baseline, Contemplation count |
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| Baseline, Preparation count |
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| Baseline, Action count |
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| Prior to intervention, Precontemplation count |
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| Prior to intervention, Contemplation count |
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| Prior to intervention, Preparation count |
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| Prior to intervention, Action count |
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| 30-day follow-up, Precontemplation count |
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| 30-day follow-up, Contemplation count |
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| 30-day follow-up, Preparation count |
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| 30-day follow-up, Action count |
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| 6-month follow-up, Precontemplation count |
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| 6-month follow-up, Contemplation count |
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| 6-month follow-up, Preparation count |
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| 6-month follow-up, Action count |
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| Immediately following intervention receipt |
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| 30-day follow-up |
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| 6-month follow-up |
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| Self-reported perception of benefits of cessation immediately following intervention receipt |
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| Self-reported perception of benefits of cessation at 30-day follow-up |
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| Self-reported perception of benefits of cessation at 6-month follow-up |
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| Immediately following intervention receipt |
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| 30-day follow-up |
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| 6-month follow-up |
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| Self-reported skill self-efficacy immediately following intervention receipt |
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| Self-reported skill self-efficacy at 30-day follow-up |
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| Self-reported skill self-efficacy at 6-month follow-up |
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| Self-reported try self-efficacy at baseline |
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| Self-reported try self-efficacy immediately following intervention receipt |
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| Self-reported try self-efficacy at 30-day follow-up |
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| Self-reported try self-efficacy at 6-month follow-up |
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