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Health Communications and Risk Processing Among Smokers

Phase 1
18 Years
65 Years
Open (Enrolling)

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Trial Information

Health Communications and Risk Processing Among Smokers

If you agree to participate, 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.
You will visit M. D. Anderson 5 times during this study; once for an orientation/intake
visit, and then for 4 more study visits.

At the first (orientation) visit, you will be asked about your feelings and moods, as well
as your smoking status. You will fill out questionnaires on a computer and complete a
breath test. The questionnaires will be about mood, stress, and smoking-related issues, and
should take about 1 hour and 30 minutes to complete. To complete the breath test, you will
blow into a tube that's attached to a machine about the size of a pocket computer. The
breath test is used to estimate the amount of tobacco smoke that you inhale. You will also
complete two computer-based tasks. Women who are pregnant should not take part in this

In addition, you will receive a palmtop personal computer and be trained in how to use it.
You will carry this small computer with you from the time of your first visit until your
last study visit. 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.

You will return for 4 visits after the orientation session. During these visits, you will
receive brief individual counseling where you will discuss techniques to help you quit
smoking. You will also be asked to fill out questionnaires on a computer about your moods
and feelings, as well as your smoking status. The questionnaires should take about 30
minutes to complete. The breath test will be given at every clinic visit.

You may be contacted by mail, telephone, and/or e-mail throughout the study and follow-up
period, to provide reminders of clinic visits. You may also be asked for information about
your smoking status during the usual reminder calls and/or calls to reschedule missed

A supply of the nicotine patch will be provided to you at each counseling session. The final
supply of the patch is provided at the final counseling session.

This is an investigational study. The nicotine patch used in this study is approved by the
Food and Drug Administration (FDA). About 20 people will take part in a pilot phase of
this study; then, another 200 participants will take part in the main study. All will be
enrolled at M. D. Anderson.

Inclusion Criteria:

1. Age 18 to 65 years

2. Current smoker with a history of at least 5 cigarettes/day for the last year

3. Motivated to quit within the next week

4. Home address and a functioning home telephone number

5. Can speak, read, and write in English at a sixth-grade literacy level

Exclusion Criteria:

1. Contraindication for nicotine patch use

2. Active substance abuse or dependence

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

4. Use of bupropion or nicotine products other than the nicotine patches supplied by the

5. Pregnancy or lactation.

6. Another household member enrolled in the study.

7. Participation in a smoking cessation program or study during the past 90 days.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Jennifer Irvin Vidrine, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Smoking
  • Risk Perception
  • Smoking Cessation
  • Nicotine Replacement Therapy
  • Questionnaire
  • Nicotine
  • Smoking



UT MD Anderson Cancer Center Houston, Texas  77030