Social Determinants and Smoking Cessation

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Questionnaires; Drug: Nicotine Patch Therapy; Behavioral: Counseling Sessions

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.

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pilot Smoking Cessation; 4 weeks nicotine patch therapy, self-help materials, and 5 in-person counseling sessions.	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.; Other Names: Survey; 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.
Smoking Cessation; 4 weeks nicotine patch therapy, self-help materials, and 7 in-person counseling sessions.	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.; Other Names: Survey; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Larkin L. Strong, PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 21, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (Estimate): March 9, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Smoking Cessation; Questionnaires; Smoker; Social Determinants; SP; GPS; Nicotine patch; Environmental Effects; Individual-level effects; Smart Phone; Global Positioning System; Saliva samples
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2010-0950; RP110025 (Other Grant/Funding Number: CPRIT); 1K99MD010468-01 (U.S. NIH Grant/Contract)