Social Determinants and Smoking Cessation
Condition: Smoking Cessation
Study type: Observational

Summary: 
      The goal of this study is to learn about the influence of the social and physical environment
      on smoking cessation (quitting smoking) among smokers.
    

Detailed description: 
      If you agree to take part in this study, you will receive help to quit smoking, including
      written self-help materials, counseling, and a supply of the nicotine patch. Over the next 6
      months, you will visit MD Anderson 7 times.

      Study Visits:

      Your first visit is the "baseline" visit when you enter the study. You will then attend 6
      additional in-person visits: Week 0 (1 week after the baseline visit), Week 1, Week 2, Week
      3, Week 12, and Week 26.

      During the baseline visit you will receive a small, hand-held personal phone and be trained
      in how to use it. You will carry this phone with you for 4 weeks. You will use the phone to
      answer questions about your mood, stress, and smoking-related issues. You will be asked to
      fill out some questions on the phone each time you have an urge to smoke. Also, the phone
      will "beep" at random and set times and ask that you answer some questions. This phone 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 5-10
      minutes. This small, hand-held personal phone will also have a GPS system activated that will
      record where you are during the waking hours every day while you are on study.

      Study Tests:

      The following tests and procedures will be performed at each study visit:

        -  You will complete some questionnaires that will include questions about your feelings,
           moods, and smoking status. These will take 60-90 minutes to complete.

        -  You will complete a breath test to help estimate (guess) the amount of cigarette smoke
           you inhale. The breath test uses a disposable cardboard tube that is attached to the
           machine, and you blow a long, slow, steady breath into it.

        -  At the baseline, Week 12, and Week 26 visits, you will have saliva samples collected for
           cotinine tests. To collect the saliva, you will be asked to put a small piece of cotton
           in your mouth for a few minutes. These samples will be used to measure the amount of
           cotinine in your saliva. Cotinine is a chemical released in your body when it breaks
           down nicotine.

        -  You will have your height, weight, and waistline measured.

      You may be contacted by mail, telephone, and/or e-mail during the study to be given reminders
      of clinic visits. You will be asked to provide the names and contact information for family
      and/or friends for the study staff to contact if the study staff has trouble reaching you.

      Length of Study:

      You will be considered off study when you complete the Week 26 visit.

      After you return the phone and GPS, all of your information that is stored on the devices
      will be erased. After the information is erased from the devices, it cannot be retrieved.

      This is an investigational study. The nicotine patch used in this study is FDA approved and
      commercially available. You will receive 4 weeks of nicotine patches.

      Up to 300 smokers will take part in this study. All will be enrolled at MD Anderson.
    

Intervention name(s): Questionnaires; Nicotine Patch Therapy; Counseling Sessions
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): Questionnaires completed at each study visit, taking 60-90 minutes, in addition to 4 Smart Phone initiated assessments per day during waking hours, taking about 5-10 minutes.; 4 weeks of nicotine patch therapy; 5 or 7 in person counseling sessions on smoking cessation: Baseline, Week 0/Quit Date (1 week following the baseline visit), Week 1, Week 2, Week 3 for Pilot Group and additional sessions Week 12 and Week 26 for other group.
Other intervention name(s): Survey
Intervention MeSH terms: Nicotine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Current smoker, age 18 years or above, with a history of at least 5 cigarettes/day for the
        last year and resides in Houston, Texas.
      
Biospecimen description: 
      Saliva samples at Baseline, week 12, and week 26 visits collected for cotinine tests.
    
Keywords: Smoker; Smoking Cessation; Social Determinants; Environmental Effects; Individual-level effects; Nicotine patch; Smart Phone; SP; Global Positioning System; GPS; Questionnaires; Saliva samples