Smoking Cessation Intervention for Tobacco Users With Lung Nodules

(TeaMOUT Trial)

Not currently recruiting at 2 trial locations
SJ
MD
Overseen ByMolly Delorit, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans who smoke and have recently been diagnosed with a lung nodule quit smoking. It compares two approaches: one group receives the TeaM OUT intervention, which includes a personalized letter and proactive calls offering support and resources to quit smoking, while the other group receives enhanced usual care, including information on how to reach a quit line if desired. The goal is to determine if the TeaM OUT intervention leads to more people using cessation services and successfully quitting smoking after one year. Veterans who currently smoke and have been recently diagnosed with a lung nodule at specific VA health centers are well-suited for this study. As an unphased trial, this study provides Veterans with a unique opportunity to contribute to research that could improve smoking cessation strategies tailored to their needs.

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 intervention is safe for veterans with lung nodules?

Research has shown that mobile phone programs designed to help people quit smoking are generally easy to use. Studies indicate that these methods can lead to higher success rates in quitting smoking compared to minimal support. For example, those using mobile phone support achieved a 9.5% success rate in quitting, while those with less support had a 5.6% success rate. This suggests that technology-based interventions can be both effective and safe for smoking cessation.

Additionally, other research highlights that methods like phone counseling are also safe and effective for quitting smoking. These approaches have been shown to help people stop smoking without major safety concerns. This is encouraging for anyone considering participation in a trial like the TeaM OUT Intervention, which uses a proactive phone approach to connect veterans with resources to quit smoking.12345

Why are researchers excited about this trial?

Researchers are excited about the TeaM OUT Intervention for smoking cessation in tobacco users with lung nodules because it leverages a "teachable moment" by directly linking the health condition to the need to quit smoking. This approach is different from the standard options, which generally do not establish this direct connection. Additionally, TeaM OUT uses a proactive Interactive Voice Response (IVR) Quit Line that initiates contact with patients, providing a more engaging and supportive method to connect them with cessation resources. This proactive and personalized approach could significantly enhance the effectiveness of smoking cessation efforts compared to more passive methods.

What evidence suggests that the TeaM OUT intervention could be effective for smoking cessation in veterans with lung nodules?

Research shows that the TeaM OUT program, one of the interventions in this trial, might help people quit smoking. This program uses a "teachable moment" by connecting quitting smoking to the discovery of a lung nodule, which can serve as a wake-up call for many. This method has shown promise in increasing motivation to quit and encouraging the use of resources like counseling and medication. Additionally, calls from a quit line make these resources easily accessible. Although specific data from this program is still being collected, similar methods have proven effective in other programs for smoking cessation. Participants in this trial may also receive Enhanced Usual Care, which provides resources without linking them to the lung nodule discovery.678910

Who Is on the Research Team?

CG

Christopher G. Slatore, MD MS

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: TeaM OUT InterventionExperimental Treatment1 Intervention
Group II: Enhanced Usual CareExperimental Treatment1 Intervention

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

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Approved in United States as Lactulose for:
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Approved in European Union as Lactulose for:
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Approved in China as Lactulose for:

Find a Clinic Near You

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+

Citations

Teachable Moment to Opt-out of Tobacco: Interactive Voice ...The purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (TeaM OUT) on increasing use of smoking cessation ...
Study design for a proactive teachable moment tobacco ...The TeaM OUT intervention combines a teachable moment for patients with newly detected incidental pulmonary nodules with a proactive interactive voice response ...
Smoking Cessation Intervention for Tobacco Users With ...The purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (TeaM OUT) on increasing use of smoking cessation ...
IIR 19-425 – HSR Study - VA Health Systems ResearchSignificance/Impact: The TeaM OUT intervention is specifically designed to increase motivation to quit, reduce roadblocks, and increase access to smoking ...
Immediate, Remote Smoking Cessation Intervention in ...Data exist to support the effectiveness of e-cigarettes in the context of lung cancer screening, with significantly higher 3-month abstinence with both ...
Outcomes of a Comprehensive Mobile Smoking Cessation ...At 3 months, Average Treatment Effects weighted abstinence rates were 4.2% for those who did not use the web-based community, 15.1% for those ...
Determinants of successful smoking cessation in outpatient ...This study found that the free smoking cessation program has a significant reducing effect on nicotine dependence among smokers, but its impact ...
Interventions for Tobacco Smoking Cessation in Adults ...Smoking cessation rates were an average of 5.6% in participants receiving usual or minimal care and 9.5% in those receiving mobile phone–based ...
A Review of Smoking Cessation Interventions - PubMed CentralMoreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...
Efficacy and Safety of Smoking Cessation Interventions in ...Our meta-analysis suggests varenicline and bupropion, as well as individual and telephone counseling, are efficacious for smoking cessation in CVD patients.
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