Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

All Drugs and Chemicals

Vasoconstrictor Agents

Central Nervous System Depressants

Central Nervous System Stimulants

Nicotine

Carbon Monoxide

Cocaine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Antimetabolites

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.

Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participants given shared decision making and discussion about screening with the LDCT provider.

Participants referred to the Quitline for counseling and NRT (nicotine patch). Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.

Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider.

LDCT provider and patient discuss options for pharmacotherapy.

Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.

Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider.

Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.

Questionnaires

Participants have a CT scan of chest to look for signs of lung cancer.

Low Dose Computed Tomography Scan

Participants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation.

Shared Decision Making + Video

Brief cessation counseling given by LDCT provider.

Cessation Counseling

Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Quitline

Participant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient.

Pharmacotherapy Discussion

Nicotine patch dispensed. Dosing at physician's discretion.

Nicotine Patch

Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.

Anti-Smoking Drug

Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,

Tobacco Treatment Program

Participant asked to blow air through a CO-measuring device.

Carbon Monoxide (CO) Level Test

Paul Cinciripini, PHD, MS, BS

The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors. All eligible participants will receive smoking cessation counseling and may be offered at least one form of smoking cessation drug. Different forms of counseling (the delivery of counseling and access to counseling) will be compared.

This is an investigational study. Participants on this study will not be prescribed smoking drugs directly by the study staff. However, participants in this study may or may not receive smoking cessation drugs, depending on what the provider thinks is in the participants best interest. All smoking cessation drugs being used are FDA approved and commercially available. It is investigational to compare the different forms of counseling participants receive.

Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will have a CT scan of your chest to look for signs of lung cancer. You will receive the results 0-4 days after the scan. If there are any abnormal areas, you will be referred to your regular doctor for follow-up. No matter what the results are, you will be advised to quit smoking. If you have previously had a low dose CT scan for lung cancer screening in the last 30 days, you may still be eligible to participate in this study. You will be asked to provide documentation of the CT scan results.

You will receive a referral for counseling to help you reduce/quit smoking. You may also discuss medications you can take to reduce smoking.

As part of your counseling treatment, you may be prescribed an FDA-approved and commercially available anti-smoking drug. This may be either nicotine replacement therapy (such as a patch, gum, or lozenge) or an oral drug (such as varenicline or buproprion). The provider will tell you when and how much of your anti-smoking drug you should take each time, based on a discussion between you and your provider. Receiving anti-smoking medication will be done through your counseling treatment and not as part of your participation in this study.

You will have at least 5, but no more than 8, smoking cessation counseling sessions over the next 12 weeks. Each session will last between 30 - 60 minutes, in which you will set a quit date, prepare for your quit date, and discuss coping skills for dealing with smoking "triggers" after your quit date. You will also discuss challenges you may have with quitting.

Study Visits:

You will have 3 additional study visits, at around 6 weeks, 12 weeks, and 6 months after the screening visit, as well as 1 follow-up phone call. At all study visits:

* You will complete questionnaires about several topics, including depression, suicide, and your smoking behavior. These questionnaires should take about 30-45 minutes in total to complete.
* Your CO level will be measured.
* Urine and/or saliva may be collected (at 12 weeks and 6 months only) for a routine test to check your cotinine and nicotine. Cotinine is a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked.

Follow-Up:

About 5 months after you start receiving counseling sessions, you will be called by a member of the study staff and asked about your recent smoking behaviors and habits. This call should last about 5-10 minutes.

Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer

Statistical power will focus on primary objective. Primary analyses use intention-to-treat (ITT) principles, with missing observations imputed as smoking.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer	NCT03059940	Smoking Cessati...	Questionnaires Low Dose Comput... Shared Decision... Cessation Couns... Quitline Pharmacotherapy... Nicotine Patch Anti-Smoking Dr... Tobacco Treatme... Carbon Monoxide...	50 Years -	M.D. Anderson Cancer Center
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer	NCT03059940	Smoking Cessati...	Questionnaires Low Dose Comput... Shared Decision... Cessation Couns... Quitline Pharmacotherapy... Nicotine Patch Anti-Smoking Dr... Tobacco Treatme... Carbon Monoxide...	50 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pharmacotherapy discussion