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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

No Placebo-Only Group

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.

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).

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

7-day point prevalence nicotine abstinence

Smoke

Secondary study objectives

Incremental Behavior Change Toward Smoking Cessation (IBC-S)

Utilization of cessation resources

Other study objectives

Interventional procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~8490

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