Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RP110025 | Other Grant/Funding Number | CPRIT | |
| 1K99MD010468-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Prevention Research Institute of Texas | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to learn about the influence of the social and physical environment on smoking cessation (quitting smoking) among smokers.
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Smoking Cessation | 4 weeks nicotine patch therapy, self-help materials, and 5 in-person counseling sessions. |
| |
| Smoking Cessation | 4 weeks nicotine patch therapy, self-help materials, and 7 in-person counseling sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of Social and Physical Environment on Smoking Cessation Among Smokers | Participants followed from 2 weeks prior to quit date through 26 weeks after quit date, assessed for 4 contiguous weeks (1 week precessation through 3 weeks postcessation) using state-of-the-science ecological momentary assessment (EMA) and global positioning system (GPS) procedures. | 3 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Larkin L. Strong, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Saliva samples at Baseline, week 12, and week 26 visits collected for cotinine tests.
|
| Nicotine Patch Therapy | Drug | 4 weeks of nicotine patch therapy |
|
| Counseling Sessions | Behavioral | 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. |
|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |