Social Determinants and Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Social Determinants and Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310842
• Other study ID #: 2010-0950
• Secondary ID: RP1100251K99MD01
• Status: Completed
• Phase: N/A
• First received: February 21, 2011
• Last updated: October 3, 2016
• Start date: July 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18 and above

2. Current smoker with a history of at least 5 cigarettes/day for the last year (participant must register a CO level of 8 or higher)

3. Motivated to quit within the next 30 days

4. Valid home address reflective of residence in Houston

5. Functioning telephone number

6. Can speak, read, and write in English

7. Marginal or adequate health literacy

Exclusion Criteria:

1. Contraindication for nicotine patch use

2. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)

3. Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study

4. Pregnancy or lactation

5. Another household member is enrolled in this protocol

6. Active substance abuse problem

7. Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Questionnaires
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.

Drug:
• Nicotine Patch Therapy
4 weeks of nicotine patch therapy

Behavioral:
• Counseling Sessions
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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Cancer Prevention Research Institute of Texas, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No