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.

National Cancer Institute (NCI)

Pfizer

M.D. Anderson Cancer Center

Lung Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.

Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.

For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.

Unsigned note to provider about cessation medication prescription

Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.

Proactive Telephone Counseling from VA Quitline

Steven B. Zeliadt, PhD MPH

This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.

The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records

Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening

Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs

Patient surveys will assess satisfaction with VA Quitline telephone counseling

Surveys will assess patient motivation to quit smoking

Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective

Surveys will assess patients' self-efficacy for quitting smoking

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment	NCT03612804	Smoking Reducti... Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms	Unsigned note t... Proactive Telep...	- 80 Years	VA Office of Research and Development
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment	NCT03612804	Smoking Reducti... Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms	Unsigned note t... Proactive Telep...	- 80 Years	VA Office of Research and Development
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 quitline

Every month we try and update this database with for quitline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for quitline

Every month we try and update this database with for quitline cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for quitline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.