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The purpose of this study is to evaluate the effectiveness of SmokefreeTXT, a smoking cessation text messaging program currently available to anyone in the United States through www.smokefree.gov, and to compare cessation outcomes for smokers living in different regions of Virginia while participants use the program. Participants will be asked to complete assessments at Baseline, 7 weeks, 3 months, and 6 months and will be asked to use a research version of SmokefreeTXT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmokfreeTXT | Experimental | Research version of the publicly available SmokefreeTXT program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmokefreeTXT | Behavioral | The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting "keywords" to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Smoking Cessation | 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) | 7 weeks after study start |
| Self-reported Smoking Cessation | 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Continuous Abstinence | Continuous abstinence, 6 weeks after initiating the quit attempt (Question wording: In the last 6 weeks, have you smoked at all? Response options: Yes; No; Not sure) | 7 weeks after study start |
| Self-reported Continuous Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41257752 | Derived | Kinchen JW, Little MA, Ritterband LM, Wiseman KP. Pilot study examining the effect of rurality on engagement and abstinence for adult users of a text-message cessation intervention. BMC Public Health. 2025 Nov 19;25(1):4061. doi: 10.1186/s12889-025-25284-6. |
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If requested, a de-identified dataset will be available to other researchers after the study is completed.
After study completion
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| ID | Title | Description |
|---|---|---|
| FG000 | SmokfreeTXT | Research version of the publicly available SmokefreeTXT program SmokefreeTXT: The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting "keywords" to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SmokfreeTXT | Research version of the publicly available SmokefreeTXT program SmokefreeTXT: The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting "keywords" to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings. |
| 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 | Self-reported Smoking Cessation | 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) | Non-responders coded as continuing to smoke | Posted | Count of Participants | Participants | 7 weeks after study start |
|
Adverse event data was collected over 6 months from time of enrollment for each participant
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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 | SmokfreeTXT | Research version of the publicly available SmokefreeTXT program SmokefreeTXT: The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting "keywords" to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara P. Wiseman, MPH, PhD | University of Virginia | 434-243-8126 | kara.wiseman@virginia.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 | Aug 25, 2021 | Feb 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
Continuous abstinence 3 months after initiating the quit attempt (Question wording: In the last 3 months, have you smoked at all? Response options: Yes; No; Not sure) |
| 3 months |
| Self-reported Smoking Cessation | 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) | 6 months |
| Self-reported Continuous Abstinence | Continuous abstinence 6 months after initiating the quit attempt (Question wording: In the last 6 months, have you smoked at all? Response options: Yes; No; Not sure) | 6 months |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Daily smoking status | Count of Participants | Participants |
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| County-level rurality | Count of Participants | Participants |
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| Primary | Self-reported Smoking Cessation | 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) | Non-responders coded as continuing to smoke | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Self-reported Continuous Abstinence | Continuous abstinence, 6 weeks after initiating the quit attempt (Question wording: In the last 6 weeks, have you smoked at all? Response options: Yes; No; Not sure) | Participants who did not respond are coded as continuing to smoke | Posted | Count of Participants | Participants | 7 weeks after study start |
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| Secondary | Self-reported Continuous Abstinence | Continuous abstinence 3 months after initiating the quit attempt (Question wording: In the last 3 months, have you smoked at all? Response options: Yes; No; Not sure) | Non-responders coded as continuing to smoke | Posted | Count of Participants | Participants | 3 months |
|
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| Secondary | Self-reported Smoking Cessation | 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) | Non-responders coded as continuing to smoke | Posted | Count of Participants | Participants | 6 months |
|
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| Secondary | Self-reported Continuous Abstinence | Continuous abstinence 6 months after initiating the quit attempt (Question wording: In the last 6 months, have you smoked at all? Response options: Yes; No; Not sure) | Any participants who did not respond to the 6-month survey was coded as continuing to smoke. | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 49 |
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| 49 |
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