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Smoking Cessation Intervention for Tobacco Users With Lung Nodules (TeaMOUT Trial)

N/A

Waitlist Available

Led By Christopher G. Slatore, MD MS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients--56 weeks after exposure to team out intervention or enhanced usual care; clinical stakeholders--at least 6 months after clinic randomization

Awards & highlights

TeaMOUT Trial Summary

This trial will evaluate the effectiveness of a smoking cessation outreach intervention on increasing use of smoking cessation resources in Veterans.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Since this trial focuses on smoking cessation outreach rather than medication or medical procedures, there aren't typical side effects. However, participants may experience stress or anxiety related to quitting smoking.

TeaMOUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 weeks after exposure to team out intervention or enhanced usual care

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 weeks after exposure to team out intervention or enhanced usual care

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks after exposure to team out intervention or enhanced usual care for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

7-day point prevalence nicotine abstinence

Smoke

Secondary outcome measures

Incremental Behavior Change Toward Smoking Cessation (IBC-S)

Utilization of cessation resources

Other outcome measures

Interventional procedure

TeaMOUT Trial Design

2Treatment groups

Experimental Treatment

Group I: TeaM OUT InterventionExperimental Treatment1 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 CareExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enhanced Usual Care

2019

Completed Phase 3

~8530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,304,203 Total Patients Enrolled

4 Trials studying Tobacco Use

2,634 Patients Enrolled for Tobacco Use

Minneapolis Veterans Affairs Medical CenterFED

72 Previous Clinical Trials

12,520 Total Patients Enrolled

Ralph H. Johnson VA Medical CenterFED

18 Previous Clinical Trials

3,194 Total Patients Enrolled

Media Library

Enhanced Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT04574518 — N/A

Tobacco Use Research Study Groups: TeaM OUT Intervention, Enhanced Usual Care

Tobacco Use Clinical Trial 2023: Enhanced Usual Care Highlights & Side Effects. Trial Name: NCT04574518 — N/A

Enhanced Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574518 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this experiment for participants?

"Clinicaltrials.gov displays that this medical research is not currently seeking participants, despite having been posted on August 12th 2022 and last edited a week later. Nevertheless, at present there are 76 other trials searching for prospective candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules

2022. "Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04574518.

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