A Smoke-Free Home Intervention in Tribal Communities

Assessing the Effectiveness of a Smoke-Free Home Program in Tribal Communities

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Best Practice; Other: Survey Administration; Behavioral: Smoking Cessation Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 575
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josh Kaufmann; Phone Number: 404-727-7718; Email: josh.kaufmann@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
      • Contact: Michelle Kegler, DrPH, MPH; Phone Number: 404-712-9957; Email: mkegler@emory.edu
      • Principal Investigator: Michelle Kegler, DrPH, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age and older
• Self-report as being a smoker or living with a smoker
• Indicate that they do not reside in a smoke-free home
• Identify as living in an American Indian household

Exclusion Criteria:

• Children under the age of 18 will not be included

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (smoke-free home program); 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.	Other: Survey Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention; Receive the smoke-free home program; Other Names: Smoking and Tobacco Use Cessation Interventions
Active Comparator: Group II (waitlist control); Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Survey Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Michelle Kegler, DrPH, MPH, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00006459 (Other Identifier: Emory University Hospital/Winship Cancer Institute); P30CA138292 (U.S. NIH Grant/Contract); NCI-2024-06174 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RSPH6261-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute); R01CA268024 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No