Smoking Cessation for Tobacco-Related Cancer Prevention

Overseen By Josh Kaufmann

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Children under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

575 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce tobacco-related cancer risk by promoting smoke-free homes in rural tribal communities. By encouraging households to go smoke-free, it seeks to cut down on secondhand smoke exposure and support quitting smoking. Participants will either receive educational materials and coaching calls through the Smoke-Free Home Intervention or continue their usual routines, with the option to join the program later. Smokers, those living with a smoker, and individuals without a smoke-free home in an American Indian household are well-suited for this study.

As an unphased trial, participants contribute to valuable research that may lead to healthier communities.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on creating smoke-free homes to reduce secondhand smoke exposure.

What prior data suggests that the smoke-free home intervention is safe?

Research shows that the smoke-free home program is safe for participants. Studies on this program have found no harmful effects. Data from several trials, each involving about 500 participants, demonstrate that the program successfully reached many households, with positive results observed at six months. The program focuses on educating families and encouraging smoke-free homes, which helps reduce exposure to secondhand smoke, known to harm health. No reports of negative effects have emerged, making it a well-accepted method for promoting healthier living spaces. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smoke-Free Home Intervention for smoking cessation because it takes a novel approach by focusing on creating a smoke-free environment at home. Unlike traditional methods like nicotine replacement therapies or prescription medications, this intervention emphasizes behavioral change through education and coaching. Participants receive educational materials and a coaching call, which aims to reinforce the benefits of maintaining a smoke-free home. This method could lead to sustainable lifestyle changes, potentially reducing tobacco-related cancer risks for both smokers and their families.

What evidence suggests that the Smoke-Free Home Intervention is effective for reducing secondhand smoke exposure?

Research shows that programs promoting smoke-free homes can greatly reduce exposure to secondhand smoke. In this trial, participants in Group I will receive the Smoke-Free Home Program, which includes mailed educational information and a coaching call. Studies have found that more families establish smoke-free rules after joining these programs compared to those who do not. These programs can also lead to smoking fewer cigarettes and more frequent quit attempts. In some cases, people who made their homes smoke-free experienced better health over time. The goal is to keep the air cleaner for everyone in the family and to help smokers cut back or quit. ^{1 2 4 6 7}

Who Is on the Research Team?

Michelle Kegler, DrPH, MPH

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals living in rural tribal communities who are interested in reducing secondhand smoke exposure from commercial tobacco in their homes. It aims to support smoking cessation and prevent tobacco-related cancer.

Inclusion Criteria

Indicate that they do not reside in a smoke-free home

Self-report as being a smoker or living with a smoker

Identify as living in an American Indian household

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the smoke-free home program, consisting of mailed educational information and a coaching call

6 weeks

1 coaching call (virtual)

Follow-up

Participants are monitored for effectiveness of the smoke-free home intervention

6 months

Follow-up assessments at 3 and 6 months

Optional Extension

Participants in the control group may optionally receive the smoke-free home program after the 6 months follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Smoke-Free Home Intervention

Trial Overview The study tests a smoke-free home intervention against best practices and survey administration to see if it can reduce secondhand smoke exposure and help people quit smoking.

How Is the Trial Designed?

Group I: Group I (smoke-free home program) Experimental Treatment 2 Interventions

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: Group II (waitlist control) Active Control 2 Interventions

Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The Smoke-Free Homes (SFH) Program was found to be acceptable and feasible for implementation across multiple 2-1-1 sites, with 70% of staff believing it contributed to more smoke-free homes in their communities.

Despite its perceived effectiveness, challenges such as sustainability, resource demands, and integration into existing workflows were significant barriers to successful implementation, highlighting the need for ongoing support and funding for future tobacco control initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an Evidence-based Tobacco Control Program at Five 2-1-1 Call Centers: An Evaluation Using the Consolidated Framework for Implementation Research. Thompson, T., Kreuter, MW., Caito, N., et al.[2023]

Self-help and minimal intervention strategies for smoking cessation can be as effective as formal programs, offering lower costs and greater accessibility for smokers.

The National Cancer Institute's Expert Advisory Panel recommended essential elements for these strategies, including increasing motivation to quit, targeting specific populations, and providing widely available resources focused on health consequences and relapse prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of self-help/minimal intervention strategies for smoking cessation. Glynn, TJ., Boyd, GM., Gruman, JC.[2019]

Implementing a tobacco order set in a computerized order-entry system significantly improved the identification of smoking status and increased referrals for smoking counseling and nicotine replacement therapy (NRT) among admitted patients, with usage rates of 76% and 81% respectively.

The intervention led to a notable increase in the percentage of patients receiving counseling (from 0.8% to 2.1%) and NRT orders (from 1.6% to 2.5%), which also enhanced the hospital's performance on smoking cessation quality measures, demonstrating its efficacy in promoting smoking cessation in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized aid to support smoking cessation treatment for hospital patients. Koplan, KE., Regan, S., Goldszer, RC., et al.[2021]

A study of 479 smokers receiving a comprehensive nurse-led smoking cessation intervention showed a 56.1% abstinence rate at 1 year and a 36.4% rate at 5 years, indicating that while long-term abstinence decreases, it remains relatively high.

The number of clinic visits was crucial for success; those attending fewer than 5 visits were significantly more likely to relapse, highlighting the importance of engagement in the cessation program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a nurse-led smoking cessation clinic at a comprehensive cancer center. Martínez, C., Castellano, Y., Fu, M., et al.[2023]

This study aims to determine if adding a smoke-free homes intervention to standard quitline services can engage more low-income smokers who are not ready to quit, potentially increasing their long-term cessation rates.

Conducted across 211 helplines in 9 states, the trial will assess the effectiveness of this approach by measuring self-reported smoking abstinence at 6 months, providing valuable insights into improving tobacco control services for low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding population-level interventions to help more low-income smokers quit: Study protocol for a randomized controlled trial. Wolff, JM., McQueen, A., Garg, R., et al.[2023]

Smoking is a major risk factor for various types of cancer, making smoking cessation a crucial step in cancer prevention.

The review emphasizes the benefits of quitting smoking for cancer patients and discusses updated findings from controlled smoking cessation studies, reinforcing the importance of following clinical guidelines for effective cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches in smoking cessation. Skaar, K., Tsoh, J., Cinciripini, P., et al.[2019]

A dedicated improvement team successfully increased the documentation of tobacco use status in hospitalized patients to 80-90%, ensuring better identification of those who need cessation support.

Counseling rates for tobacco cessation among patients admitted with heart failure or pneumonia improved significantly to 82-96%, highlighting the effectiveness of standardized processes and community resources in supporting hospitalized tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the quality of care for the hospitalized tobacco user--one institution's transformational journey. Liu, SK., Prior, E., Warren, C., et al.[2021]

A quit-line for smoking cessation in Iran successfully helped 122 out of 148 participants (82.4%) quit smoking, demonstrating the efficacy of telephone counseling for smokers who cannot attend in-person programs.

The program showed a sustained abstinence rate of 59% after 1 month, which decreased over time, indicating that while initial success is high, ongoing support is crucial for long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telephone quit-line for smokers in iran: 12 months follow up results. Heydari, G., Jianfar, G., Alvanpour, A., et al.[2021]

The 'Staying Free' program is a research-based smoking cessation model specifically designed for hospitalized patients, highlighting the importance of utilizing hospital stays as a chance to promote quitting smoking.

Insights gained from implementing this program suggest a systematic approach is essential for effectively integrating smoking cessation interventions into clinical practice and training for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating smoking cessation research findings into clinical practice: the "staying free" program. Miller, NH.[2019]

A hospital-based smoking cessation program that included behavioral counseling and support was effective, achieving a 32% abstinence rate at 12 months among participants who attended at least two sessions.

Factors such as self-belief in quitting, having a heart condition, and not growing up with smoking siblings were linked to higher chances of long-term abstinence, highlighting the importance of social and psychological influences in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of hospital-based smoking cessation. Fung, PR., Snape-Jenkinson, SL., Godfrey, MT., et al.[2019]

Creating a smoke-free home (SFH) significantly increases the likelihood of quitting smoking among low-income smokers, with effects observed at both 3-month and 6-month follow-ups in a study involving 941 participants.

For smokers who did not quit, those with a SFH reported a greater reduction in daily cigarette consumption and more frequent quit attempts compared to those without a SFH, indicating that SFHs can support smoking reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cessation and reduction in smoking behavior: impact of creating a smoke-free home on smokers. Haardörfer, R., Kreuter, M., Berg, CJ., et al.[2020]

The 'Don't smoke in our home' trial, involving 218 women, showed that while brief counseling did not significantly enhance the implementation of totally smoke-free homes and cars, written materials alone led to modest increases in smoke-free environments among participants.

Despite the intervention, only a small percentage of smokers quit or reduced smoking indoors and in cars, indicating that while awareness and resources can help, more effective strategies are needed to achieve substantial behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "Don't smoke in our home" randomized controlled trial to protect children from second-hand smoke exposure at home. Chellini, E., Gorini, G., Carreras, G.[2022]

The 'Intervention Programme Against Smoking' in Austria aims to integrate smoking cessation into standard healthcare practices by training health professionals, including physicians and pharmacists, to support smokers in quitting.

The program targets 'dissonant smokers'—those who want to quit—by providing a range of cessation techniques, from self-help to pharmacological interventions, as part of a broader strategy to combat tobacco-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smoking intervention program]. Schmeiser-Rieder, A., Schoberberger, R., Gredler, B., et al.[2006]

Youths living in smoke-free homes (SFH) were significantly less likely to become established smokers over an 11-year period, with those in non-SFH being nearly twice as likely to start smoking compared to their peers in SFH.

The study found that the protective effect of SFH applied to both children and adolescents, regardless of whether their parents smoked, highlighting the importance of implementing household smoking bans to reduce smoking initiation among youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke-Free Homes and Youth Smoking Behavior in Italy: Findings From the SIDRIAT Longitudinal Study. Gorini, G., Carreras, G., Cortini, B., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7368345/

Disseminating a Smoke-free Homes Program to Low ... All three RCTs, with a sample size around 500 per trial, showed significant program effects, with 38%–63% of households reached for follow-up at 6 months ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06583148

A Smoke-Free Home Intervention in Tribal Communities 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 ...

3. sph.emory.edu sph.emory.edu/eprc/research/smoke-free-homes

Smoke-Free Homes Our results showed that more intervention participants made their home smoke-free than comparison participants. We next conducted an effectiveness trial in ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-022-14423-y

The smoke-free home study: study protocol for a cluster ... In prior population-based studies, a smoke-free home was associated with reduced consumption, increased quit attempts [16, 17], reduced relapse ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2825372

Survival Outcomes of an Early Intervention Smoking ... Survival over 15 years increased for those quitting smoking at 3 months (adjusted hazard ratio [aHR], 0.75 [95% CI, 0.67-0.83]), 6 months (aHR, 0.79 [95% CI, ...

6. reporter.nih.gov reporter.nih.gov/project-details/10442550

Intergrating a Smoke-Free Home Intervention into the 5As to ... Pooled data from our three RCTs, combined with results from a national dissemination study, document the potential of the intervention to support cessation. We ...

7. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10371944&term=CA268024

Division of Cancer Control & Population Sciences - Grant Details ABSTRACT Smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural American Indian communities.