Smoking Cessation Intervention for Tobacco Users With Lung Nodules
(TeaMOUT Trial)
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.12345
Is the smoking cessation treatment safe for humans?
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.1591011
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the TeaM OUT intervention or Enhanced Usual Care, including letters and IVR Quit Line calls
Follow-up
Participants are monitored for smoking cessation outcomes and utilization of cessation resources
Treatment Details
Interventions
- Enhanced Usual Care
- TeaM OUT Intervention
Enhanced Usual Care is already approved in United States, European Union, China for the following indications:
- Hepatic encephalopathy
- Constipation
- Hepatic encephalopathy
- Constipation
- Hepatic encephalopathy
- Constipation
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborator
Ralph H. Johnson VA Medical Center
Collaborator