| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA235773-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.
There is an urgent need to engage more low-income smokers in activities that lead to quitting. The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines. But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers. Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers. Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation. These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home. In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes). In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes. At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services. The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day. The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services. With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Quitline only | Active Comparator | Smokers in this study group will be offered their state Tobacco Quitline programs |
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| Tobacco Quitline plus Smoke Free Homes | Experimental | Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco Quitline | Behavioral | Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline ("fax-back"). |
| Measure | Description | Time Frame |
|---|---|---|
| 7day Point Prevalence for Smoking | Percentage of participants who have 7 day smoking abstinence | 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Accept the Tobacco Quitline Program |
|
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Inclusion Criteria:
Exclusion Criteria:
-Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Kreuter, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40018164 | Derived | McQueen A, Wolff J, Grimes L, Teshome E, Garg R, Thompson T, Carpenter K, Kegler MC, Kreuter MW. Comparing acceptance of smoking cessation and smoke-free home intervention offers and associated factors among people with low income in the USA: baseline results of a randomised controlled trial. BMJ Public Health. 2024 Apr 22;2(1):e000843. doi: 10.1136/bmjph-2023-000843. eCollection 2024 Jun. | |
| 37080354 | Derived | Wolff JM, McQueen A, Garg R, Thompson T, Fu Q, Brown DS, Kegler M, Carpenter KM, Kreuter MW. Expanding population-level interventions to help more low-income smokers quit: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Jun;129:107202. doi: 10.1016/j.cct.2023.107202. Epub 2023 Apr 18. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The HCRL Data Center will make the datasets and other materials available without cost to researchers and analysts after a data sharing agreement is completed. Consistent with NIH guidelines, the data sharing agreement: (1) records a request for data use and detailed description of the intent of use; (2) details the study's publication guidelines, including acknowledging and citing project personnel as appropriate; (3) ensures IRB compliance, including not using these data for non-research purposes; and (4) stipulates that users will not share or distribute the data to others without written permission.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tobacco Quitline Only | Smokers in this study group will be offered their state Tobacco Quitline programs |
| FG001 | Tobacco Quitline Plus Smoke Free Homes | Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tobacco Quitline Only | Smokers in this study group will be offered their state Tobacco Quitline programs |
| BG001 | Tobacco Quitline Plus Smoke Free Homes | Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 7day Point Prevalence for Smoking | Percentage of participants who have 7 day smoking abstinence | Participants were not included if they were lost to follow-up or were duplicate enrollees. | Posted | Count of Participants | Participants | 6 month follow-up |
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From date of enrollment through completion of follow-up (up to 6 months).
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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 | Tobacco Quitline Only | Smokers in this study group will be offered their state Tobacco Quitline programs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Kreuter, Ph.D. | Washington University School of Medicine | 314-935-3701 | mkreuter@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 | Jan 4, 2022 | Sep 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2020 | Sep 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Two group intervention; standard care vs. standard + additional service
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Participants are unaware of the arms and principal investigators are unaware of participant's randomization to study arm
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| Smoke Free Home | Behavioral | The intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free. Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach. |
|
| Baseline and 3-month follow-up |
| Death |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Proportion of Participants Who Accept the Tobacco Quitline Program |
| At baseline, participants weren't included if they were duplicate entries. At 3-month follow-up, participants weren't included if they were duplicated entries or if they were lost to follow-up. Also, in Arm 2 at 3-month follow-up, if participants had chosen the quitline at baseline and did not quit, they were not re-offered the quitline; they were only offered Smoke-Free Homes. This was a planned part of the study design. | Posted | Count of Participants | Participants | Baseline and 3-month follow-up |
|
|
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| 1 |
| 987 |
| 0 |
| 987 |
| 0 |
| 987 |
| EG001 | Tobacco Quitline Plus Smoke Free Homes | Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention | 0 | 986 | 0 | 986 | 0 | 986 |
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| 3-month follow-up |
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