A Smoke-Free Home Intervention in Tribal Communities

NCT06583148 | Recruiting

• 5 other identifiers: STUDY00006459NCI-2024-06174RSPH6261-24P30CA138292R01CA268024
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Smoke-Free Vehicles Assessed Via Telephone Interview

  At 3 and 6 months

• Secondhand Smoke (SHS) Exposure In The Home Assessed via Telephone Interview

  At 3 and 6 months

• Number of Cigarettes Smoked In the Home

  At 3 and 6 months

• Public Support for Smoke-Free Tribal Housing Assessed Via Telephone Interview

  At 3 and 6 months

Study Arms (2)

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.

Behavioral: Smoking Cessation Intervention; Other: Survey Administration

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.

Other: Best Practice; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group II (waitlist control)

Smoking Cessation Intervention BEHAVIORAL

Receive the smoke-free home program

Also known as: Smoking and Tobacco Use Cessation Interventions

Group I (smoke-free home program)

Survey Administration OTHER

Ancillary studies

Group I (smoke-free home program); Group II (waitlist control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Children under the age of 18 will not be included

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• Emory University: lead

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Smoking Devices

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Michelle Kegler, DrPH, MPH

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josh Kaufmann

CONTACT

404-727-7718; josh.kaufmann@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be supervised by the study statistician and data collection staff will be blind to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 3, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)