Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06174 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00006459 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| RSPH6261-24 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source | |
| R01CA268024 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial evaluates a smoke-free home intervention for reducing exposure to secondhand smoke from commercial tobacco in homes of participants who live in rural tribal communities. Smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural tribal communities. Smoke-free policies, including those that target homes, can reduce exposure to secondhand smoke and support smoking cessation. Rural and racial/ethnic inequities intersect to increase tobacco-related harms among Indigenous populations. A smoke-free home program may improve the health of the household as well as impact smoking behavior among the family unit by reducing secondhand smoke exposure.
PRIMARY OBJECTIVE:
I. To assess the effectiveness of a smoke-free homes intervention for tribal communities.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2.
GROUP II: Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.
After completion of study intervention, participants are followed up at 3 and 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (smoke-free home program) | Experimental | Participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2. |
|
| Group II (waitlist control) | Active Comparator | Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Smoke-Free Home | Which statement best describes rules about smoking inside your home? There are no rules about smoking inside your home? Smoking is not allowed anywhere inside your home? Smoking is allowed in some places or at some times in your home? Smoking is allowed anywhere inside your home? Those answering that smoking is not allowed anywhere inside their home are classified as having a smoke-free home. It will be self-reported & measured using air nicotine monitor from a subset of 20% participants to assess validity of the self-report, adjusting for possible traditional uses of tobacco and use of electronic cigarettes. Receiver-operator curve analysis to determine the optimal thresholds for a smoke-free home & complete case data, two-level logistic multilevel models accounting for nesting of participants in tribal communities with group assignment predicting a binary smoke-free home status (full ban/no full ban). | At 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoke-Free Vehicles Assessed Via Telephone Interview | Smoke-Free Vehicles will be assessed via telephone interview using a measure adapted from the Centers for Disease Control and Prevention (CDC)'s National Adult Tobacco Survey, 2009-2010. What about smoking cigarettes in your vehicle(s) (including cars, SUVs, and trucks) - would you say: There are no rules about smoking in the vehicle(s), smoking is sometimes allowed in the/some vehicle(s), smoking is never allowed in the/any vehicle, no car, don't know. Those answering smoking is never allowed in the/any vehicle are classified as having a smoke-free vehicle rule. We will use 3-level logistic growth curve models using Statistical Analysis System (SAS) procedure (PROC) Bayesian Generalized Linear Mixed Modeling (BGLIMM) to model all of the collected data. Data cleaning, descriptive analyses, as well as bivariate and multilevel modeling, will be conducted using Statistical Analysis System (SAS) version 9.4. Mediation analyses will be conducted in Mplus statistical software version 8.5. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josh Kaufmann | Contact | 404-727-7718 | josh.kaufmann@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Kegler, DrPH, MPH | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Randomization will be supervised by the study statistician and data collection staff will be blind to group assignment.
| Smoking Cessation Intervention | Behavioral | Receive the smoke-free home program |
|
|
| Survey Administration | Other | Ancillary studies |
|
| At 3 and 6 months |
| Secondhand Smoke (SHS) Exposure In The Home Assessed via Telephone Interview | SHS exposure in the home will be assessed via telephone interview using a measure adapted from the Centers for Disease Control and Prevention (CDC)'s National Youth Tobacco Survey, 2023. During the past 7 days, how many days have people smoked in your home in your presence? Response options 0 to 7. We will use 3-level logistic growth curve models using Statistical Analysis System (SAS) procedure (PROC) Bayesian Generalized Linear Mixed Modeling (BGLIMM) to model all of the collected data. Data cleaning, descriptive analyses, as well as bivariate and multilevel modeling will be conducted using Statistical Analysis System (SAS) 9.4. Mediation analyses will be conducted in Mplus statistical software version 8.5. | At 3 and 6 months |
| Number of Cigarettes Smoked In the Home | Will use 3-level logistic growth curve models using Statistical Analysis System (SAS) procedure (PROC) Bayesian Generalized Linear Mixed Modeling (BGLIMM) to model all of the collected data. Data cleaning, descriptive analyses, as well as bivariate and multilevel modeling will be conducted using Statistical Analysis System (SAS) version 9.4. Mediation analyses will be conducted in Mplus statistical software version 8.5. | At 3 and 6 months |
| Public Support for Smoke-Free Tribal Housing Assessed Via Telephone Interview | To what extent do you support or oppose a complete cigarette smoking ban in the following settings: tribally owned multi-unit housing. Response options include a range from 1 (strongly oppose) to 4 (strongly support). | At 3 and 6 months |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |