A Smoke-Free Home Intervention in Tribal Communities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2029-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Randomization will be supervised by the study statistician and data collection staff will be blind to group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Receive the smoke-free home program

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Smoking Cessation Intervention

Receive the smoke-free home program

Intervention Type BEHAVIORAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Smoking and Tobacco Use Cessation Interventions

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Michelle C. Kegler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Kegler, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

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Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Josh Kaufmann

Role: CONTACT

[email protected]

404-727-7718

Facility Contacts

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Michelle Kegler, DrPH, MPH

Role: primary

[email protected]

404-712-9957