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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a phone-based program called Telephone All Nations Breath of Life, designed to help American Indians quit smoking, and compares it to a standard program. It aims to determine which approach is more effective in helping people stop smoking for at least seven days at six months after starting. The trial also examines continuous quitting and reduced smoking after six and twelve months. Individuals who identify as American Indian, smoke at least one cigarette a day, and have a stable address and phone number might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to more effective smoking cessation programs.

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 prior data suggests that this smoking cessation program is safe?

Research has shown that the Telephone All Nations Breath of Life program is generally safe for participants. Past studies reported no serious side effects, suggesting that the program is well-tolerated. Tested with American Indian communities, it focuses on helping people quit smoking through personal counseling and support. The program employs safe methods like phone calls and text messages, which carry low risk. Overall, evidence indicates no harmful effects from joining this program, making it a promising option for those who want to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telephone All Nations Breath of Life program because it offers a culturally tailored approach to smoking cessation for American Indian communities, which is a significant departure from standard options like general counseling and nicotine replacement therapies. This program uniquely incorporates individual telephone counseling with culturally relevant content, along with supportive text messaging and educational materials specifically designed to resonate with American Indian values and experiences. By addressing cultural factors and building a personalized connection, researchers believe this program could enhance engagement and effectiveness in helping individuals quit smoking compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that the Telephone All Nations Breath of Life (tANBL) program, a treatment in this trial, helps people in American Indian communities quit smoking. One study found that 31.1% of participants stopped smoking six months after starting the program, surpassing other quit rates. Early results also indicate that 65% of participants quit by the end of the program, with 25% remaining smoke-free six months later. The program is culturally tailored and uses phone counseling, text messages, and educational materials to aid smoking cessation. Overall, these findings suggest that the tANBL program can effectively reduce smoking in this community. Participants in this trial may also receive the Comparison Program, a non-culturally targeted smoking cessation program, which includes individual counseling, text messaging, and educational materials. ^{1 2 6 7 8}

Who Is on the Research Team?

Christine M Daley, PhD, MA, SM

Principal Investigator

Lehigh University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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 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]

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 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 '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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04764175

NCT04764175 | Telephone All Nations Breath of Life The primary outcome is 7-day point prevalence abstinence from smoking cigarettes at 6 months post-baseline. Secondarily, the study examines continuous ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5067178/

All Nations Breath of Life: A Randomized Trial of Smoking ... The purpose of this study was to determine if a culturally tailored smoking-cessation program, All Nations Breath of Life (ANBL), is more effective than a non- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3061617/

All Nations Breath Of Life: Using Community-Based ... Our preliminary self-report data show quit rates of 65% at program completion and 25% at six months post-baseline. Keywords: American Indian, Smoking Cessation, ...

4. researchgate.net researchgate.net/publication/314129496_Abstract_A34_Understanding_the_Predictors_of_Smoking_Cessation_in_a_Culturally_Tailored_Smoking_Cession_Program_Created_for_American_Indians

Understanding the Predictors of Smoking Cessation in a ... The purpose of this study was to test the effectiveness of the All Nations Breath of Life program (ANBL); a 12-week culturally-tailored smoking cessation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5892857/

Feasibility of Implementing the All Nations Breath of Life ... At 6 months post-baseline (primary endpoint), 31.1% of retained participants quit smoking (p < .0001 compared to the highest quit rates among multi-tribal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01106456

NCT01106456 | Smoking Cessation for American Indians American Indians and Alaska Natives (AI/ANs) have the highest smoking rates of the major racial/ethnic groups in the United States, approaching 40% to ...

7. withpower.com withpower.com/trial/phase-4-2021-b4a70

Smoking Cessation Program for Quitting Smoking (tANBL Trial) 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 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379716301933

All Nations Breath of Life: A Randomized Trial of Smoking ... Intention-to-treat, imputing all non-responses as smokers, the self-reported point prevalence abstinence rates at 12 weeks were 27.9% in the ANBL arm and 17.4% ...