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

Immune System Diseases

Hypersensitivity

Tin Fluorides

Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.

Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.

Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.

Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.

Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.

Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.

Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.

Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.

Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Varenicline Dosing: 0.5 mg/day by mouth for Days 1-3; 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter.

Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 weeks.

Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day for 11 weeks.

Placebo Patch

Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.

Placebo Tablet

Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. Questionnaires should take about 30-45 minutes total to complete. On Days 17, 24, 38, and 73, done over the phone.

Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. These sessions take about 15 minutes each time.

Counseling Sessions

Participant asked to watch slides. During the lab session, brain electrical activity checked with an electroencephalogram (EEG). Participant completes computer tasks, including questionnaires, that will measure emotions and attention level. These tasks should take about 90 minutes to complete. The lab session may last up to 2 hours.

Lab Session

Saliva tested to check cotinine level at baseline, on Days 8 and 17, end of treatment visit, and at 3 months and 6 months after quitting smoking.

Saliva Test

The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to Group 1 or 2.

* If you are in Group 1, you will receive varenicline and a placebo patch. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
* If you are in Group 2, you will receive an active nicotine patch and a placebo tablet.

Neither you nor the study doctor will know which group you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving (called "unblinding").

Once the study has ended and the Data Safety Monitoring Board (DSMB) at MD Anderson has granted approval, you may be unblinded at your request.

Study Drug Administration:

You will start taking your assigned study drug(s) the day after Visit 1.

You should take varenicline/placebo tablets by mouth with a cup (8 ounces) of water after eating a full meal. On Days 1-3, you will take 1 dose of the study drug each morning. Starting on Day 4, and then every day after that, you will take 1 dose in the morning and 1 dose in the evening (for a total of 2 doses of the study drug each day). You must return any study drug bottles as well as any unused study drug to the study staff at each study visit.

You should apply the nicotine/placebo patch to the upper arm. You should put it in a slightly different place each day to avoid skin irritation. You may take the patch off at night to avoid sleeping problems.

You will be given a study diary to record how many cigarettes you smoke (if any) each day while you are on study.

You must return your study diary and any unused study drugs, patches, and/or containers at each study visit.

Study Visits (Visits 1-7):

At every study visit:

* You will complete questionnaires about several topics, including depression, suicide, your smoking behavior, and any effects from the study drug. These questionnaires should take about 30-45 minutes in total to complete.
* You will be giving the opportunity to complete the questionnaires verbally with a study staff member (either on phone or in person depending on the visit number) or electronically on your computer using a website administered by an online survey development company called Qualtrics.
* You will receive counseling about quitting smoking, where you will talk about possible "triggers" for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each.

At Visits 1, 4 and 6:

* Urine or saliva will be collected for a routine test to check your cotinine, nicotine, and anabasine levels. Cotinine is a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked. Anabasine is used to show if nicotine is found in the blood due to a nicotine replacement therapy or from tobacco use.
* Your CO level and weight. will be measured.
* If you did not have one during screening, you will have a physical exam.
* If you did not complete at one during screening or before Visit 1, you will complete the EEG/lab session.
* If you can become pregnant, urine will be collected for a pregnancy test.
* At V1, if your CO machine tests results are unclear, and the study staff thinks it is appropriate, a NicAlert test will be performed. Urine will be collected for the NicAlert test, which is more sensitive at detecting levels of smoking than the CO machine.

During counseling on Day 8, you will set a "quit date" for stopping smoking for about 1 week after you start taking the study drug/placebo. You should not quit smoking before the quit date. You may also set goals to reduce smoking. You should try to stay smoke-free after the quit date. You will also be given a drug instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling.

Visits 2, 3, 5 and 7 will be conducted over the phone. You will complete questionnaires about several topics (either on the phone or electronically), including depression, mood, your smoking behavior, and any effects from the study drug. You will also be asked about any drugs you may be taking. Each call should take about 25-45 minutes.

The study staff will call you 1 day before your quit date and 3 days after your quit date to check on your progress in quitting smoking. Each call should take about 10-15 minutes.

Lab Session:

You will take part in a lab session at or before Visit 1 to test your brain activity. You will be asked to watch slides. The slides will include pictures of people, nature, and artwork. Slides showing nude people, medical procedures, and victims of car crashes will also be shown. You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study.

During the lab session, your brain electrical activity will be checked with an electroencephalogram (EEG). To do this, small sensors will be placed on your scalp and face. You should not drink more than 2 cups of coffee or other caffeinated drinks for at least 2½ hours before the session. At the lab session, you may be asked to smoke a cigarette if the doctor thinks it is needed for you to show your normal smoking behavior.

You will also complete computer tasks, including questionnaires that will measure your emotions and attention level. These tasks should take about 90 minutes to complete.

The lab session may last up to 2 hours.

Ecological Momentary Assessments (EMA):

EMA are used to gather information about your mood and cravings as they happen in your day-to-day life. At your randomization visit, you will be loaned a smart phone device, and will be asked to complete questionnaires on the device at different times everyday throughout the active treatment phase (12 weeks). In these questionnaires, you will be asked about events from the previous day, such as cigarettes per day, alcohol intake, mood, sleep, motivation, and whether you took your prescribed drugs on time. These questionnaires should take up to about 20 minutes per day to complete.

Length of Treatment:

You will receive the study drug/placebo for up to 12 weeks. You will be taken off study early if the doctor thinks it is in your best interest or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

End-of-Treatment Visit (Visit 8):

After you have finished taking the study drug/placebo, the following tests and procedures will be performed:

* Your CO level will be measured.
* Blood (about 2 teaspoons) will be drawn to check your liver and kidney function.
* Urine or saliva will be collected to measure your nicotine, anabasine, and cotinine level.
* You will complete the same questionnaires you completed at the regular study visits.
* You will receive counseling about quitting smoking.
* If you can become pregnant, urine will be collected for a pregnancy test.

Follow-Up Visits (Visits 9 and 10):

At about 3 and 6 months after you have stopped smoking, the following tests and procedures will be performed:

* Your CO level will be measured.
* Urine or saliva will be collected to measure your nicotine, anabasine, and cotinine level.
* You will complete the same questionnaires you completed at the regular study visits.

This is an investigational study. Varenicline and the nicotine patch are both FDA approved and commercially available to help people stop smoking. The study doctor can explain how the study drugs are designed to work.

Up to 160 participants will be enrolled in this portion of the study. All will take part at MD Anderson.

Reward Sensitivity and Pharmacotherapy for Smoking Cessation

The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity

Continuous abstinence over the last 4 weeks of treatment (i.e. EOT-end of treatment) will serve as the primary outcome measure. Saliva will be collected to measure cotinine level.

For prolonged abstinence, relapse defined by 7 or more consecutive days of smoking or smoking at least 1 cigarette over two consecutive weeks from the end of the grace period to a future time point (e.g., EOT, 3- and 6- months post-quit date).

NAL PHARMA

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.

Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.

Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.

Participants complete saliva cotinine test 3 months after intervention.

Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.

Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.

Participants complete saliva cotinine test 3 months after intervention.

Participants receive an 8 week supply of Nicotine patches.

Questionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention.

Pamphlet given to participant describing health and financial reasons to quit smoking.

Pamphlet

Standard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes.

Automated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.

Participants also have access to additional counseling content on the smart phone, which can be used at any time.

Phone Counseling Sessions

Participants complete saliva cotinine test 3 months after intervention.

Standard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.

Automated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.

Smart phone

Diana S. Hoover, PHD

The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.

Baseline Questionnaire:

If you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level. This should take about 15-20 minutes to complete.

Study Groups:

After completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being placed in either group.

Both groups will receive smart phones and an 8-week supply of nicotine patches with instructions on how to use them. Each group will receive different methods of advice for quitting smoking.

If you are assigned to Group 1, the following study procedures will be performed:

* You will receive brief advice on how to quit smoking once at the time of enrollment. The advice will be given from a pamphlet that has information such as health problems related to smoking, how many Americans are affected each year, financial problems related to smoking, nicotine replacement therapy options, preparation for quitting smoking, and encouragement to quit.
* On the smart phone, you will have 5 phone counseling sessions for support in quitting smoking throughout the 8-week intervention treatment. The calls should last about 15 minutes.

If you are assigned to Group 2, the following study procedures will be performed:

* On the smart phone, you will receive brief video clips with advice on how to quit smoking, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.
* You will also have access to additional counseling content on the smart phone, which you can use at any time.

Weekly Smart Phone Questionnaires:

Both groups will complete questionnaires on the smart phone every week for 8 weeks. Each questionnaire will have questions about your current smoking status, your motivation level to stop smoking, and things that may have a negative effect on your quitting. The questionnaire should take about 15 minutes to complete.

Follow-up Saliva Test and Questionnaire:

About 3 months after your first smart phone intervention, both groups will complete a saliva test and take a photograph of the test results. The saliva test results will be used to check your smoking activity. Supplies and instructions will be given to you when you are enrolled on the study and the instructions will be available on the smart phone. You will also complete a questionnaire similar to the baseline questionnaire.

Length of Study:

You will be on study for about 3 months.

This is an investigational study. Up to 50 participants will take part in this study. All will be enrolled at the Harris Health System (Thomas Street Health Center).

Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study

Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study

Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.

Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.

Standard Treatment (ST)

Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.

Automated Treatment (AT)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to small number of subjects registered, study halted without analysis.

Dr. Lorna McNeill, MPH,PHD/ Chair, Health Disparities Research

Data were not collected due to early termination of the protocol

Smoking Abstinence: 3-month Assessment Via Smart Phone

Overall Study

Anti-Infective Agents

Ethanol

Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.

Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.

Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.

Carbon Monoxide (CO) Test

Participants receive general health education and handouts.

Health Education and Handouts

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.

Culturally Tailored Reading Materials

Participants attend 3 counseling sessions during the study.

Marcel A. de Dios, PHD

The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.

Baseline Visit:

If you agree to take part in this study, the following tests and procedures will be performed at the beginning of the study:

* You will complete 10 questionnaires about your demographics (age, race, sex, and so on), medical history, smoking status, alcohol use, religion, how "in control" you feel of your own life, and cultural background. These should take about 1½ hours to complete.
* You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body. This test involves blowing your breath through a hand-held device.
* You will learn how to keep a diary about your progress in your attempts to quit smoking. °You must bring this diary with you to every visit.
* You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
* If you can become pregnant, you will have a urine pregnancy test. To take part in this study, you must not be pregnant.3
* The total length of the baseline visit will be approximately 2.5 hours.

Study Groups:

You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will have an equal chance of being in each group. This is done because no one knows if one study group is better, the same, or worse than the other group.

Counseling Sessions:

The study group that you are in will determine the way that health information is presented to you in one-on-one counseling sessions.

* If you are in Group 1, you will receive general health education. The counselor will discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to you and your smoking. The counselor will also give you handouts about the health topic.
* If you are in Group 2, you and the counselor will discuss how your smoking and your culture may relate to each other. The counselor will also provide you with reading materials that highlight how aspects of your culture relate to health, smoking and quitting.
* If you are in Group 3, you will receive the same cultural counseling and handouts that Group 2 received. Also, you will have additional talks about the use of drugs to help you stop smoking and some common feelings that Latinos may experience with being unsuccessful when trying to quit. The counselor will also offer you a plan for using medication successfully.

All participants will attend 3 counseling sessions during the study. Each of these counseling sessions will be audio recorded. Your first counseling session will be at baseline. The other two counseling sessions will be at your Week 2 and Week 6 visits (described below).

All participants will be given a 12 week supply of nicotine patches and information about how to use the nicotine patch. At each study visit, you will be given the amount of patches that you need to last you to your next visit, plus a few extra in the event that a patch falls off or is damaged.

During your first counseling session, you will be asked to choose a quit date. This is simply a date that you would like to begin using the patch and make an attempt to not smoke.

Week 2 and Week 6 Study Visits:

At each of these study visits, all participants will have the following procedures:

* You will complete a brief interview about your progress and any side effects you may be having. This should take about 10 minutes to complete.
* You will complete 2 questionnaires about your tobacco use and satisfaction with the study. These should take about 10 minutes to complete.
* You will complete a CO test.
* You will be asked if you have smoked any other substances, such as marijuana, in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

Follow-Up Visits:

About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these visits, the following tests and procedures will be performed:

* You will complete the same set of questionnaires about your tobacco and alcohol use, culture, religion, and sense of control that you did at your baseline visit.
* You will complete a CO test.
* You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

Length of Study:

Your study participation will be over after you complete the 6-month follow-up visit.

This is an investigational study. Up to 36 people will be enrolled in this study. All will take part at MD Anderson.

Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.

Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.

Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.

MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.

Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Health Education (HE)

Culturally-Tailored (CT)

Culturally-Tailored With Adherence Enhancement (CT+AE)

Age, Categorical

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Due to the limited scope, the study was not fully powered for conclusive hypothesis testing of group differences on variables of interest. The analytic strategy focused on descriptive statistics and estimation rather than formal hypothesis testing.

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
Reward Sensitivity and Pharmacotherapy for Smoking Cessation	NCT02162849	Tobacco Use Ces...	Varenicline Nicotine Patch Placebo Patch Placebo Tablet Questionnaires Counseling Sess... Lab Session Saliva Test	18 Years - 75 Years	M.D. Anderson Cancer Center
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study	NCT02302859	Tobacco Use Ces...	Nicotine Patch Questionnaires Pamphlet Phone Counselin... Saliva Test Smart phone	18 Years -	M.D. Anderson Cancer Center
Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers	NCT02596711	Tobacco Use Ces... Cancer Preventi...	Nicotine Patch Questionnaires Carbon Monoxide... Health Educatio... Culturally Tail... Counseling Sess...	18 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
Reward Sensitivity and Pharmacotherapy for Smoking Cessation	NCT02162849	Tobacco Use Ces...	Varenicline Nicotine Patch Placebo Patch Placebo Tablet Questionnaires Counseling Sess... Lab Session Saliva Test	18 Years - 75 Years	M.D. Anderson Cancer Center
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study	NCT02302859	Tobacco Use Ces...	Nicotine Patch Questionnaires Pamphlet Phone Counselin... Saliva Test Smart phone	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for nrt

Every month we try and update this database with for nrt 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 nrt

Every month we try and update this database with for nrt 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 nrt 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.