Smoking Cessation Program for Quitting Smoking

(tANBL Trial)

Overseen By Luke Swimmer, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lehigh University

Disqualifiers: Unstable phone number, Household member

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This project formally test an individual, telephone-based version of the All Nations Breath of Life smoking cessation program (tANBL) for American Indians (AI) for efficacy versus an untailored comparison program (CP). The primary outcome is 7-day point prevalence abstinence from smoking cigarettes at 6 months post-baseline. Secondarily, the study examines continuous abstinence and reduction in smoking at both 6 and 12 months post-baseline, as well as demographic predictors of cessation and/or reduction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Smoking Cessation Program for Quitting Smoking treatment?

Research shows that telephone quitlines, like the one used in the Smoking Cessation Program, are effective in helping people quit smoking. These quitlines provide accessible and evidence-based support, which can significantly reduce the number of tobacco users when combined with healthcare professional referrals. ^{1 2 3 4 5}

Is the All Nations Breath of Life program safe for humans?

The available research does not specifically mention any safety concerns for the All Nations Breath of Life program, suggesting it is generally safe for participants. ^{6 7 8 9 10}

How is the Telephone All Nations Breath of Life treatment for quitting smoking different from other treatments?

The Telephone All Nations Breath of Life treatment is unique because it uses a toll-free telephone quitline, which provides smokers with easy and free access to support for quitting smoking, unlike traditional face-to-face clinician visits. This approach simplifies the process and makes it more accessible to a wider audience. ^{1 11 12 13 14}

Research Team

Christine M Daley, PhD, MA, SM

Principal Investigator

Lehigh University

Eligibility Criteria

This trial is for American Indians aged 18 or older who smoke at least one cigarette per day. Participants must have a stable telephone number and address for receiving calls and program materials over 12 months. Those with household members already in the study, or without a stable phone number, cannot join.

Inclusion Criteria

Have a home address or stable address to which we can mail program supplies

You smoke cigarettes daily.

You identify as an American Indian based on your own statement.

Exclusion Criteria

Household member already in the study

Cannot provide a stable phone number for the purpose of the study that will be available for a minimum of 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual telephone counseling, motivational text messaging, and educational materials for smoking cessation

6 months

Weekly phone calls

Follow-up

Participants are monitored for smoking cessation outcomes and reduction in smoking

6 months

Long-term Follow-up

Participants are further monitored for continuous abstinence and smoking reduction

6 months

Treatment Details

Interventions

• Comparison Program
• Telephone All Nations Breath of Life

Trial Overview The study compares two smoking cessation programs: Telephone All Nations Breath of Life (tANBL) tailored for American Indians, against an untailored comparison program (CP). Success is measured by participants' ability to abstain from smoking after six months and continuous abstinence or reduction in smoking up to twelve months.

Participant Groups

Group I: Telephone All Nations Breath of Life Experimental Treatment 1 Intervention

This is a culturally targeted smoking cessation program developed for American Indian communities. It includes individual telephone counseling, text messaging, and educational materials.

Group II: Comparison Program Active Control 1 Intervention

This is a non-culturally targeted smoking cessation program. It includes individual counseling, text messaging, and educational materials.

Telephone All Nations Breath of Life is already approved in United States for the following indications:

Approved in United States as Telephone All Nations Breath of Life for:

• Smoking cessation

Who Is Running the Clinical Trial?

Lehigh University

Lead Sponsor

Trials

24

Recruited

6,800+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Findings from Research

The Louisiana Tobacco Control Program has established a smoking cessation helpline, which is a valuable resource for clinicians to help their patients quit smoking.

Research shows that simple discussions by physicians about quitting smoking can increase success rates by 40%, highlighting the significant role healthcare providers play in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smoking cessation helpline for Louisiana smokers--and a new resource for medical professionals. Gleckler, E., Bates, BR., Schilleci, E., et al.[2004]

The Ask-Advise-Connect (AAC) approach significantly increased the enrollment of smokers in treatment programs, with 7.8% of identified smokers enrolling compared to only 0.6% in the traditional Ask-Advise-Refer (AAR) method, representing a 13-fold increase.

This study involved 10 family practice clinics in Houston, Texas, and assessed smoking status for over 42,000 patients, demonstrating that proactive outreach by quitlines can effectively link smokers to cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ask-Advise-Connect: a new approach to smoking treatment delivery in health care settings. Vidrine, JI., Shete, S., Cao, Y., et al.[2022]

A Web-based educational program significantly improved nurses' ability to refer smokers to a quitline and perform smoking cessation interventions, with 333 nurses participating in the study across 30 hospitals.

Nurses who accessed the educational program showed a 74% higher likelihood of consistently referring smokers to the quitline compared to those who only received printed materials, highlighting the effectiveness of interactive training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing nursing referral to telephone quitlines for smoking cessation using a web-based program. Sarna, L., Bialous, SA., Ong, MK., et al.[2021]

Tobacco use is the leading preventable cause of death and disability in the U.S., highlighting the urgent need for effective cessation resources.

Establishing a national tobacco quitline network, as recommended in 2003, can significantly reduce tobacco use by providing accessible, evidence-based support through health professionals, emphasizing the importance of collaboration between nurses and quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco quitlines in the United States. Fildes, EE., Wilson, MA., Crawford, BJ., et al.[2018]

A study involving 600 hospitalized smokers tested a brief intervention to facilitate access to telephone quitline services, but found no difference in 6-month abstinence rates compared to standard cessation advice, with both groups reporting a 24% abstinence rate.

Despite 65% of the intervention group completing the quitline intake call, the facilitation intervention did not enhance the effectiveness of quitlines for helping hospitalized smokers quit, suggesting that quitlines may not be a viable solution for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial. Warner, DO., Nolan, MB., Kadimpati, S., et al.[2018]

The All Nations Snuff Out Smokeless (ANSOS) program was developed specifically for American Indians, who have the highest rates of smokeless tobacco use in the U.S., and showed a 68.8% retention rate with 33 out of 48 participants completing the program.

Among those who completed the program, 34% reported being abstinent from smokeless tobacco, and when accounting for those lost to follow-up, the overall cessation rate was 22.9%, indicating that the program may be effective and culturally appropriate for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing All Nations Snuff Out Smokeless (ANSOS): A Culturally Tailored Smokeless Tobacco Cessation Program for American Indians. Daley, CM., Lewis, C., Nazir, N., et al.[2022]

A survey of 13 telephone tobacco quit lines (QLs) revealed that most (63.6%) use a single intervention protocol for all non-cigarette tobacco and nicotine-containing product (TNCP) users, indicating a lack of tailored treatment options.

Only one QL had a specialized protocol for smokeless tobacco users, while others referred hookah and electronic cigarette users to external resources, highlighting the need for further research to develop effective, specialized interventions for TNCP users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quit_line treatment protocols for users of non-cigarette tobacco and nicotine containing products. Linde, BD., Ebbert, JO., Talcott, GW., et al.[2022]

The culturally tailored smoking-cessation program, All Nations Breath of Life (ANBL), showed a higher self-reported smoking abstinence rate at 6 months (20.1%) compared to the non-tailored program (12.0%), suggesting it may be more effective for American Indian smokers.

At 12 weeks, the ANBL program also had a significantly higher self-reported abstinence rate (27.9%) compared to the non-tailored program (17.4%), indicating that culturally relevant interventions could enhance smoking cessation efforts in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All Nations Breath of Life: A Randomized Trial of Smoking Cessation for American Indians. Choi, WS., Beebe, LA., Nazir, N., et al.[2022]

The 'All Nations Breath of Life' (ANBL) program is being tested as a culturally-tailored smoking cessation intervention specifically for American Indian smokers, with a total of 448 participants involved in the trial.

This study is significant as it is the first controlled trial to evaluate the effectiveness of a culturally-specific approach to smoking cessation in a population with a high smoking prevalence, aiming to address the urgent health crisis among American Indians and Alaska Natives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial. Choi, WS., Faseru, B., Beebe, LA., et al.[2021]

A culturally-tailored smoking cessation program called All Nations Breath of Life (ANBL) was developed and evaluated, successfully recruiting American Indian smokers through educational sessions at cultural events, with 30% participation via tele-video and 9% in-person.

Participants in both tele-video and in-person sessions showed significant increases in motivation and confidence to quit smoking, highlighting the effectiveness of culturally relevant education in engaging underserved populations in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's not just about recruitment: An exploratory look at tobacco education sessions to increase participation into smoking cessation programs among American Indians. Lumpkins, CY., Filippi, MK., Nazir, N., et al.[2021]

The establishment of the national quitline number 1-800-QUIT-NOW in 2004 provided free access to smoking cessation services for all smokers in the U.S., significantly improving support for those trying to quit.

Quitlines have proven to be effective alternatives to in-person clinician contact, offering a streamlined approach to help smokers access cessation resources and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simplicity sells: Making smoking cessation easier. Bonniot Saucedo, C., Schroeder, SA.[2010]

The CDC's Tips From Former Smokers® campaign revealed that quitline registrants differ significantly based on whether they learned about the quitline through radio or TV ads, which can help tailor future tobacco control strategies.

Registrants from radio ads were typically younger, more educated, and predominantly male, while those from TV ads were more likely to be Black, non-Hispanic, and had fewer years of education, indicating the need for targeted outreach efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in Quitline Registrants' Characteristics During National Radio Versus Television Antismoking Campaigns. Zhang, L., Rodes, R., Mann, N., et al.[2021]

A study involving 159 participants revealed that while many smokers, including adolescents, are aware of quitline services, there is a lack of interest in using them, with some only considering it if they struggle to quit on their own.

To enhance the effectiveness of quitlines in promoting smoking cessation, future marketing should focus on educating smokers about the free and confidential nature of these services and their benefits, potentially increasing call volume and improving public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of the US National Tobacco Quitline Among Adolescents and Adults: A Qualitative Study, 2012-2013. Waters, EA., McQueen, A., Caburnay, CA., et al.[2022]

The study found that implementing a fax referral system linking community health centers (CHCs) to the New York State Quitline significantly increased adherence to cessation assistance practices among providers, with intervention sites being 2.4 times more likely to refer patients to the Quitline.

Providers in intervention sites were also 1.8 times more likely to offer medication counseling or prescriptions for smoking cessation, highlighting the effectiveness of the referral system in enhancing clinician support for patients trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of linking community health centers to a state-level smoker's quitline on rates of cessation assistance. Shelley, D., Cantrell, J.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A smoking cessation helpline for Louisiana smokers--and a new resource for medical professionals. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Ask-Advise-Connect: a new approach to smoking treatment delivery in health care settings. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Increasing nursing referral to telephone quitlines for smoking cessation using a web-based program. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Tobacco quitlines in the United States. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot Testing All Nations Snuff Out Smokeless (ANSOS): A Culturally Tailored Smokeless Tobacco Cessation Program for American Indians. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Quit_line treatment protocols for users of non-cigarette tobacco and nicotine containing products. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

All Nations Breath of Life: A Randomized Trial of Smoking Cessation for American Indians. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

It's not just about recruitment: An exploratory look at tobacco education sessions to increase participation into smoking cessation programs among American Indians. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Simplicity sells: Making smoking cessation easier. [2010]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Differences in Quitline Registrants' Characteristics During National Radio Versus Television Antismoking Campaigns. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Perceptions of the US National Tobacco Quitline Among Adolescents and Adults: A Qualitative Study, 2012-2013. [2022]

14. England pubmed.ncbi.nlm.nih.gov

The effect of linking community health centers to a state-level smoker's quitline on rates of cessation assistance. [2022]