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Tobacco-Related CarcinomaNCT06583148

A Smoke-Free Home Intervention in Tribal Communities

A study testing Best Practice, Smoking Cessation Intervention and Survey Administration in people with Tobacco-Related Carcinoma, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco-Related Carcinoma
What is being tested?
Best Practice, Smoking Cessation Intervention and Survey Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
575 participants
Where
1 siteUnited States
Study dates
15 Nov 2024to 31 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Children under the age of 18 will not be included

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Josh Kaufmann contact

404-727-7718

josh.kaufmann@emory.edu

United States1 site, 1 recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Michelle Kegler, DrPH, MPH, 404-712-9957, mkegler@emory.edu

    Michelle Kegler, DrPH, MPH

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Best Practice, Smoking Cessation Intervention, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive usual care

  • Smoking Cessation InterventionBehavioural

    Also called Smoking and Tobacco Use Cessation Interventions

    Receive the smoke-free home program

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06583148
Study groupRoleWhat they receive
Group I (smoke-free home program)ExperimentalParticipants 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.
Receives: Behavioral: Smoking Cessation Intervention; Other: Survey Administration
Group II (waitlist control)Active comparatorParticipants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.
Receives: Other: Best Practice; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At 3 and 6 months

Secondary outcomes (4)

  1. 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.

    Measured: At 3 and 6 months

  2. 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.

    Measured: At 3 and 6 months

  3. 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.

    Measured: At 3 and 6 months

  4. 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).

    Measured: At 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start15 Nov 2024
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
575 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583148
Sponsor's protocol ID
STUDY00006459
Other IDs
NCI-2024-06174, STUDY00006459, RSPH6261-24, P30CA138292, R01CA268024
Status last verified
Dec 2025
First submitted
14 Aug 2024
Last updated
8 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Smoking Cessation Intervention and Survey Administration in people with Tobacco-Related Carcinoma, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Josh Kaufmann (404-727-7718, josh.kaufmann@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported Smoke-Free Home (time frame: At 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06583148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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