Smoking Cessation Intervention for Tobacco Users With Lung Nodules

(TeaMOUT Trial)

Recruiting at 2 trial locations

Overseen By Molly Delorit, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

Compensation: Varies

Number of Visits: Unknown

2400 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (TeaM OUT) on increasing use of smoking cessation resources in Veterans. The hypotheses are 1) patients included in the TeaM OUT group will have higher accession of cessation services, such as counseling and medication therapies, compared to patients in enhanced usual care and 2) more patients in the TeaM OUT group will have quit smoking at one year after the intervention. Veterans with a recently diagnosed lung nodule who currently smoke will receive the TeaM OUT intervention or Enhanced Usual Care. The TeaM OUT intervention has 2 parts: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit Line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources. The enhanced usual care group will receive a letter that provides information about how to contact the IVR Quit Line. The IVR system will track referrals to cessation services. Additional information about smoking status and use of cessation resources will be collected from the electronic health record and surveys. .

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 Enhanced Usual Care, Duphalac, Kristalose, TeaM OUT Intervention for smoking cessation?

Research suggests that extended-duration treatments for tobacco dependence, like those involving pharmacotherapies, can increase the chances of quitting smoking and reduce relapse rates. Additionally, integrating smoking cessation interventions within lung cancer screening programs has been shown to promote quitting, indicating that such settings can be effective for smoking cessation efforts. ^{1 2 3 4 5}

Is the smoking cessation treatment safe for humans?

Research suggests that extended-duration treatments for tobacco dependence, like those using varenicline, bupropion, or nicotine replacement therapy, probably do not increase the risk of serious side effects. ^{1 3 6 7 8}

How does the TeaM OUT Intervention treatment for smoking cessation differ from other treatments?

The TeaM OUT Intervention, involving treatments like Duphalac and Kristalose, is unique because it combines smoking cessation support with lung cancer screening, potentially using the screening as a teachable moment to encourage quitting. This approach is different from standard smoking cessation methods, which may not integrate with lung health checks or use the results as motivation. ^{1 5 9 10 11}

Research Team

Christopher G. Slatore, MD MS

Principal Investigator

VA Portland Health Care System, Portland, OR

Eligibility Criteria

This trial is for Veterans who are active smokers and have recently been diagnosed with a lung nodule, under surveillance at specific VA Health Care Systems. There are no specific exclusion criteria, so all eligible veterans can participate.

Inclusion Criteria

You are currently being treated at specific VA health care centers in Portland, Minneapolis, or Charleston.

I have a newly found lung spot and am being watched closely.

You are currently smoking.

Exclusion Criteria

No exclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the TeaM OUT intervention or Enhanced Usual Care, including letters and IVR Quit Line calls

56 weeks

Follow-up

Participants are monitored for smoking cessation outcomes and utilization of cessation resources

16 weeks

Treatment Details

Interventions

• Enhanced Usual Care
• TeaM OUT Intervention

Trial Overview The study compares two approaches to help Veterans quit smoking: the TeaM OUT intervention (a personalized letter plus proactive calls from an IVR Quit Line offering resources) versus Enhanced Usual Care (information on how to contact the IVR Quit Line).

Participant Groups

Group I: TeaM OUT Intervention Experimental Treatment 1 Intervention

The TeaM OUT Intervention has 2 elements: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources.

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

The Enhanced Usual Care arm also has two elements: 1) a letter that a) describes the nodule without linking it to smoking cessation (i.e. no teachable moment) with b) wording to contact an Optional IVR Quit line if desired and 2) the Optional IVR Quit line which a) offers smoking cessation resources and b) helps connect the patient to those resources.

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Ralph H. Johnson VA Medical Center

Collaborator

Trials

21

Recruited

5,700+

References

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

Extended Duration Treatment of Tobacco Dependence: A Systematic Review and Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Co-development of an evidence-based personalised smoking cessation intervention for use in a lung cancer screening context. [2022]

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

A randomized, double-blind, placebo-controlled clinical evaluation of a nicotine sublingual tablet in smoking cessation. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of offering nicotine replacement therapy as a relapse prevention treatment in routine smoking cessation services. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions within the context of Low-Dose Computed Tomography lung cancer screening: A systematic review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

A multicenter phase 3 trial of lobeline sulfate for smoking cessation. [2021]

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

Decreasing smoking behaviour and risk through CYP2A6 inhibition. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A randomized trial of naltrexone for smoking cessation. [2019]

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

Immediate smoking cessation support versus usual care in smokers attending a targeted lung health check: the QuLIT trial. [2022]

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

Impact of specialist and primary care stop smoking support on socio-economic inequalities in cessation in the United Kingdom: a systematic review and national equity initial review completed 22 January 2019; final version accepted 19 July 2019 analysis. [2021]

11. China pubmed.ncbi.nlm.nih.gov

Lung cancer screening and smoking cessation efforts. [2021]