~480 spots leftby Dec 2025

Smoking Cessation Intervention for Tobacco Users With Lung Nodules

(TeaMOUT Trial)

Recruiting in Palo Alto (17 mi)
+2 other locations
CG
Overseen byChristopher G. Slatore, MD MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group

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. .

Research Team

CG

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

Treatment Details

Interventions

  • Enhanced Usual Care (Behavioral Intervention)
  • TeaM OUT Intervention (Behavioral Intervention)
Trial OverviewThe 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
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.

Enhanced Usual Care is already approved in China for the following indications:

🇨🇳
Approved in China as Lactulose for:
  • Hepatic encephalopathy
  • Constipation

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+
Dr. Grant Huang profile image

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella profile image

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials
77
Recruited
355,000+

Ralph H. Johnson VA Medical Center

Collaborator

Trials
21
Recruited
5,700+