Clinical trial NCT01008748
Conditions: Smoking Cessation
Keywords: Smoking Latinos Mexican American Spanish-speaking smokers Ecological momentary assessment Nicotine patch Smoking cessation counseling Questionnaire EMA
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-09-01; Completion date: 2016-09-01
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to learn how neighborhood and individual factors affect the ability to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit smoking.

Detailed description:
If you agree to take part in this study, you will receive treatment to help you quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Over the next 6 months, you will visit M. D. Anderson 5 times during this study. You will also be called 3 times for smoking cessation counseling during this study.

Study Visits:

First (Orientation) Visit You will be asked about your feelings and moods, as well as how many cigarettes you smoke. You will fill out questionnaires on a computer. The questionnaires will be about your mood, stress level, and smoking-related issues. They should take about 1 hour and 30 minutes to complete.

You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.

You will give two saliva samples at this visit. To collect the first saliva sample, you will place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check the amount of cotinine in the body. Cotinine is a chemical that is produced in your saliva when your body breaks down nicotine.

The second saliva sample will be collected by spitting into a container. Researchers will perform genetic tests with these samples to look for genes that control the production and use of neurotransmitters, naturally occurring chemical messengers in the brain. People with certain genes may have a more difficult time quitting smoking, because of the way nicotine affects these chemicals. Your second saliva sample will be stored in a biorepository at M. D. Anderson for use in future research related to nicotine addiction, smoking, and/or cancer. Your saliva sample will be placed in a bank of biological samples and data that is available to researchers conducting research related to cancer or nicotine dependence.

Before your saliva sample can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of M. D. Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at M. D. Anderson, including research involving your saliva sample from this bank, must first be approved by the IRB.

Your samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. Other researchers using your samples will not be able to link this data to you.

Genetic information obtained will not be provided to you.

Second (Baseline) Visit:

Your second visit (Baseline) will occur 1 week before your Quit date visit. You will fill out questionnaires on a computer. The questionnaires will be about your, stress level, social support and smoking-related issues. They should take about 1 hour and 30 minutes to complete.

You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.

Your Height, Weight and Waist circumference measures will be taken.

You will also receive individual counseling. During counseling, you will discuss techniques to help you quit smoking.

In addition, you will receive a small, hand-held personal computer and be trained in how to use it. You will carry this computer with you for 4 weeks. You will use the computer to answer questions about your mood, stress, and smoking-related issues. You will be asked to fill out some questions on the computer each time you have an urge to smoke or you actually smoke. Also, the computer will "beep" at random and set times and request that you answer some questions. This computer will not wake you during the night and you will be able to wait to answer questions for a few minutes if it goes off when you are busy. Answering the questions should take about 5 to 10 minutes.

Third (Quit Day) and Fourth (Week 3) Study Visits:

Your Third visit (Quit Day) will occur 1 week after your Second (Baseline) visit. Your Fourth visit will occur 3 weeks after your Quit Day. During these visits, you will be asked to fill out questionnaires on a computer about your moods and feelings, as well as how many cigarettes you smoke. The questionnaires should take about 30 minutes to complete.

You will also receive individual counseling. During counseling, you will discuss techniques to help you quit smoking.

On your Third visit, you will complete the breath test and your Weight and Waist circumference measures will also be taken.

At your Third visit you will be given a supply of nicotine patches to last until your Fourth visit.

At your Fourth visit you will be given a one week supply of nicotine patches. You will be on nicotine patches for a total of 4 weeks. At the Fourth Visit, you will also complete the breath test, will give a saliva sample and your Weight and Waist circumference measures will be taken.

Last (Week 26) Visit:

This visit will occur 26 weeks (or 6 months) after your Quit Day. During these visits, you will be asked to fill out questionnaires on a computer about your moods and feelings, as well as how many cigarettes you smoke.

The questionnaires should take about 1 1/2 hours to complete.

You will complete the breath test, your Weight and Waist circumference measures will be taken and you will also give a saliva sample at the last (Week 26) visit.

Telephone Calls:

Between your first (Orientation) visit and your Fourth (Week 3) visit, you will receive 3 calls from a smoking cessation counselor. You will receive your first call a few days before your quit day. You will receive a second call 1 week after your Quit Day and another call 2 weeks after your Quit Day. During these calls, you will discuss techniques to help you quit smoking. These calls will last 10 to 15 minutes and will be scheduled in advance.

Additional Information:

You may be contacted by mail, telephone, and/or e-mail throughout the study to remind you about clinic visits. You may also be asked for information about your smoking status during the usual reminder calls and/or calls to reschedule missed appointments.

Length of Study:

You will be considered off study when you complete the Week 26 (or Last) visit.

This is an investigational study. The nicotine patch is FDA approved and commercially available. Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
Interventions: intervention 1: Nicotine Replacement Therapy (NRT) intervention 2: Questionnaire intervention 3: Counseling intervention 4: Self-Help Materials
Intervention descriptions: intervention 1: NRT for participants who smoke \>10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits. intervention 2: Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time. intervention 3: Each counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish. intervention 4: Spanish-language self-help materials currently used by the NCI's Cancer Information Service.

Protocol documents: