Smoking Cessation Intervention for Tobacco-Related Cancer Prevention

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Landline, VOIP phone, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

300 Participants Needed

Trial Summary

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 treatment Nicotine and Tobacco Message Framing, Nicoderm CQ, Nicorette, Habitrol, Nicotrol Inhaler, Nicotrol NS for smoking cessation in cancer prevention?

Research shows that quitting smoking can improve treatment outcomes and quality of life for cancer patients, and nicotine replacement therapies like patches and gum are proven strategies to help people stop smoking. These therapies are effective in reducing tobacco use and improving health outcomes, even for those with smoking-related diseases. ^{1 2 3 4 5}

Is the smoking cessation treatment generally safe for humans?

The safety of nicotine replacement therapies like Nicoderm CQ, Nicorette, and Nicotrol Inhaler has been evaluated in various studies, and they are generally considered safe for human use. These treatments are designed to help people quit smoking by providing a controlled dose of nicotine, which reduces withdrawal symptoms and cravings. ^{6 7 8 9 10}

How does the drug Nicotine and Tobacco Message Framing differ from other smoking cessation treatments?

Nicotine and Tobacco Message Framing combines nicotine replacement therapy (NRT) with a unique approach that focuses on how messages about smoking cessation are framed to the patient. This treatment is distinct because it not only uses nicotine products like patches or gum to reduce withdrawal symptoms but also emphasizes the psychological aspect of quitting by tailoring messages to motivate and support individuals in their efforts to stop smoking. ^{2 11 12 13 14}

What is the purpose of this trial?

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.

Research Team

Joanne G Patterson

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for LGBTQ+ young adults who smoke or use nicotine/tobacco products. It aims to see if different ways of presenting information about the risks can help them quit or change their smoking habits.

Inclusion Criteria

Currently reside in the United States (US)

Self-identify as LGBTQ+

An ever user of ENDS and combustible tobacco who currently use ENDS, combustible cigarettes, or both ENDS and combustible cigarettes

Exclusion Criteria

Have a landline or Voice Over Internet Protocol (VOIP) phone number

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multimedia messaging service (MMS) anti-tobacco messages 3 times a week and a check-in text message once a week for a total of 6 weeks

6 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in smoking behavior and risk perceptions at 6 and 12 weeks post-baseline

6 weeks

Follow-up assessments at 6 and 12 weeks

Treatment Details

Interventions

• Nicotine and Tobacco Message Framing

Trial Overview The study tests how effective culturally targeted messages are in changing smoking behavior. Participants will receive health education, interviews, surveys, and interventions through text messaging designed to encourage quitting.

Participant Groups

Group I: Arm II (Relative Risk messages) Experimental Treatment 4 Interventions

Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.

Group II: Arm I (Absolute Risk messages) Experimental Treatment 4 Interventions

Participants receive AR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.

Group III: Arm III (control messages) Active Control 4 Interventions

Participants receive control MMS messages on health risks of UV/sun exposure TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.

Nicotine and Tobacco Message Framing is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Nicotine for:

• Smoking cessation

Approved in United States as Nicotine for:

• Smoking cessation

Approved in Canada as Nicotine for:

• Smoking cessation

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

Smoking cessation can significantly reduce the risk of premature death and improve quality of life, even after the onset of smoking-related diseases, highlighting the importance of quitting at any stage.

Clinicians can effectively help patients quit smoking by using structured advice and various pharmacotherapies, including nicotine replacement therapies and medications like bupropion, with new options like varenicline potentially benefiting those who struggle with existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for nicotine dependence. Henningfield, JE., Fant, RV., Buchhalter, AR., et al.[2019]

A study of 111 cancer patients in a smoking cessation program revealed that most were Caucasian, married, and diagnosed with head and neck cancer, indicating specific demographic trends among those who continue to smoke after diagnosis.

Quit motivation was positively linked to higher self-efficacy and perceived benefits of quitting, while negatively associated with nicotine addiction and depressive symptoms, suggesting that tailored interventions addressing these factors could improve cessation efforts in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. Schnoll, RA., Rothman, RL., Newman, H., et al.[2022]

Continued tobacco use after a cancer diagnosis significantly worsens treatment outcomes, increasing toxicity, recurrence, second tumors, and mortality rates among cancer patients.

Quitting smoking after a cancer diagnosis is associated with improved treatment outcomes, and patients are generally receptive to evidence-based cessation support, highlighting the need for better access and efficacy of cessation programs in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco use in the oncology setting: advancing clinical practice and research. Gritz, ER., Toll, BA., Warren, GW.[2022]

A systematic review of smoking cessation interventions for patients with head and neck cancer identified only 3 eligible studies, highlighting a significant lack of research in this area.

Among the interventions, only the nurse-delivered cognitive-behavioral therapy combined with pharmacotherapy showed a significant increase in smoking cessation rates, suggesting that this approach may be effective for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation care among patients with head and neck cancer: a systematic review. McCarter, K., Martínez, Ú., Britton, B., et al.[2019]

The Committed Quitters Program (CQP) significantly improved quit rates among smokers who actively used the program materials, with 38.8% abstinence at 6 weeks and 18.2% at 12 weeks, compared to 30.7% and 11.1% in the standard User's Guide (UG) group.

Overall abstinence rates did not differ significantly between the CQP and UG groups, indicating that the effectiveness of CQP is particularly notable among those who engage with the tailored materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. Shiffman, S., Paty, JA., Rohay, JM., et al.[2019]

In a randomized trial involving 68 adult smokers, those using electronic nicotine delivery systems (ENDS) showed a significant reduction in cigarette smoking compared to a control group, indicating potential efficacy in smoking cessation.

Participants using the higher nicotine (24 mg) ENDS were more likely to continue using the product and make independent purchases, suggesting that higher nicotine delivery may enhance user engagement and support smoking reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects. Carpenter, MJ., Heckman, BW., Wahlquist, AE., et al.[2018]

In a clinical trial with 43 smokers, nicotine polyestex gum led to a significantly higher smoking cessation rate of 50% compared to only 9% for the placebo group after 3 months, indicating its effectiveness.

The gum was found to be safe, with adverse events occurring at similar rates to the placebo, and while both groups reported improved quality of life, there was no significant difference between them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nicotine polyestex gum on smoking cessation and quality of life. Rungruanghiranya, S., Ekpanyaskul, C., Hattapornsawan, Y., et al.[2017]

The novel nicotine delivery device, Eclipse, significantly reduced the number of cigarettes smoked per day from 19.1 to 2.1, without increasing withdrawal symptoms or decreasing blood nicotine levels, suggesting it may help smokers reduce consumption.

However, Eclipse increased carbon monoxide levels from 21.0 ppm to 33.0 ppm, indicating it may not be a safer alternative to traditional cigarettes compared to the Nicotrol inhaler, which decreased both cigarette consumption and carbon monoxide levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial investigating effect of a novel nicotine delivery device (Eclipse) and a nicotine oral inhaler on smoking behaviour, nicotine and carbon monoxide exposure, and motivation to quit. Fagerström, KO., Hughes, JR., Rasmussen, T., et al.[2019]

In a study of 3,093 quit attempters from the US PATH Study, using electronic nicotine delivery systems (ENDS) was associated with a 6% increase in the likelihood of maintaining cigarette abstinence for at least 30 days, making it a popular cessation aid.

However, while ENDS helped some individuals quit, they did not significantly reduce daily cigarette consumption among those who relapsed, and pharmaceutical aids like varenicline and bupropion showed no substantial benefit in promoting persistent abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can E-Cigarettes and Pharmaceutical Aids Increase Smoking Cessation and Reduce Cigarette Consumption? Findings From a Nationally Representative Cohort of American Smokers. Benmarhnia, T., Pierce, JP., Leas, E., et al.[2023]

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.

Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. Anczak, JD., Nogler, RA.[2022]

Varenicline is the most effective first-line pharmacotherapy for smoking cessation, showing a significant effect compared to placebo with an odds ratio of 2.27, followed by bupropion (1.69) and nicotine replacement therapy (1.60).

Despite some safety concerns, regulatory agencies deem bupropion and varenicline to have a favorable benefit/risk profile, but healthcare providers should monitor patients for potential neuropsychiatric symptoms, especially in those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. Aubin, HJ., Luquiens, A., Berlin, I.[2022]

Most smokers in the U.S. want to quit and can significantly increase their chances of success by using treatments like nicotine replacement therapy (NRT), bupropion, or varenicline, which can double their odds of quitting.

Physicians can play a crucial role in helping smokers by providing brief interventions and connecting them to effective counseling and treatment options, emphasizing that treating tobacco dependence should be prioritized in healthcare just like other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to help a smoker who is struggling to quit. Rigotti, NA.[2023]

Nicotine replacement therapy (NRT) and sustained-release bupropion (bupropion SR) are effective pharmacotherapies for smoking cessation, increasing quit rates by 1.5 to over 2 times when combined with behavioral interventions.

National and international guidelines recommend systematic approaches for smoking cessation, including identifying smokers, assessing their readiness to quit, providing supportive advice, and administering approved therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of smoking cessation. Sutherland, G.[2018]

References

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

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

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

Pharmacotherapy for nicotine dependence. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. [2022]

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

Tobacco use in the oncology setting: advancing clinical practice and research. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Smoking cessation care among patients with head and neck cancer: a systematic review. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. [2019]

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

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects. [2018]

8. Thailand pubmed.ncbi.nlm.nih.gov

Effect of nicotine polyestex gum on smoking cessation and quality of life. [2017]

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

Randomised trial investigating effect of a novel nicotine delivery device (Eclipse) and a nicotine oral inhaler on smoking behaviour, nicotine and carbon monoxide exposure, and motivation to quit. [2019]

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

Can E-Cigarettes and Pharmaceutical Aids Increase Smoking Cessation and Reduce Cigarette Consumption? Findings From a Nationally Representative Cohort of American Smokers. [2023]

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

Tobacco cessation in primary care: maximizing intervention strategies. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]

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

Strategies to help a smoker who is struggling to quit. [2023]

14. New Zealand pubmed.ncbi.nlm.nih.gov

Current approaches to the management of smoking cessation. [2018]