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

Smoking Cessation Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Smoking Cessation

• NCT number: NCT03059940
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: June 16, 2017
• Completion date: June 1, 2024