Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

Baseline Visit:

If you agree to take part in this study, the following tests and procedures will be performed
at the beginning of the study:

- You will complete 10 questionnaires about your demographics (age, race, sex, and so on),
medical history, smoking status, alcohol use, religion, how "in control" you feel of
your own life, and cultural background. These should take about 1½ hours to complete.

- You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in
your body. This test involves blowing your breath through a hand-held device.

- You will learn how to keep a diary about your progress in your attempts to quit smoking.
°You must bring this diary with you to every visit.

- You will be asked if you have smoked any non-tobacco substances in the last 2 days. If
you have, you will provide an additional CO sample 2 days after the last time you smoked
the substance.

- If you can become pregnant, you will have a urine pregnancy test. To take part in this
study, you must not be pregnant.3

- The total length of the baseline visit will be approximately 2.5 hours.

Study Groups:

You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will
have an equal chance of being in each group. This is done because no one knows if one study
group is better, the same, or worse than the other group.

Counseling Sessions:

The study group that you are in will determine the way that health information is presented
to you in one-on-one counseling sessions.

- If you are in Group 1, you will receive general health education. The counselor will
discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to
you and your smoking. The counselor will also give you handouts about the health topic.

- If you are in Group 2, you and the counselor will discuss how your smoking and your
culture may relate to each other. The counselor will also provide you with reading
materials that highlight how aspects of your culture relate to health, smoking and
quitting.

- If you are in Group 3, you will receive the same cultural counseling and handouts that
Group 2 received. Also, you will have additional talks about the use of drugs to help
you stop smoking and some common feelings that Latinos may experience with being
unsuccessful when trying to quit. The counselor will also offer you a plan for using
medication successfully.

All participants will attend 3 counseling sessions during the study. Each of these counseling
sessions will be audio recorded. Your first counseling session will be at baseline. The other
two counseling sessions will be at your Week 2 and Week 6 visits (described below).

All participants will be given a 12 week supply of nicotine patches and information about how
to use the nicotine patch. At each study visit, you will be given the amount of patches that
you need to last you to your next visit, plus a few extra in the event that a patch falls off
or is damaged.

During your first counseling session, you will be asked to choose a quit date. This is simply
a date that you would like to begin using the patch and make an attempt to not smoke.

Week 2 and Week 6 Study Visits:

At each of these study visits, all participants will have the following procedures:

- You will complete a brief interview about your progress and any side effects you may be
having. This should take about 10 minutes to complete.

- You will complete 2 questionnaires about your tobacco use and satisfaction with the
study. These should take about 10 minutes to complete.

- You will complete a CO test.

- You will be asked if you have smoked any other substances, such as marijuana, in the
last 2 days. If you have, you will provide an additional CO sample 2 days after the last
time you smoked the substance.

Follow-Up Visits:

About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these
visits, the following tests and procedures will be performed:

- You will complete the same set of questionnaires about your tobacco and alcohol use,
culture, religion, and sense of control that you did at your baseline visit.

- You will complete a CO test.

- You will be asked if you have smoked any non-tobacco substances in the last 2 days. If
you have, you will provide an additional CO sample 2 days after the last time you smoked
the substance.

Length of Study:

Your study participation will be over after you complete the 6-month follow-up visit.

This is an investigational study. Up to 36 people will be enrolled in this study. All will
take part at MD Anderson.

Inclusion Criteria:

1. Adults at least 18 years of age

2. Current smoker (>5 cigarettes per day for the past 3 months)

3. Able to speak and read English or Spanish

4. Agree to participate in the study and be available for 6 weeks of treatment and 6
months of follow-up

5. Willing to set a quit date within 2 weeks of enrollment date

6. Identify as being of Latino heritage, ethnicity, or ancestry

Exclusion Criteria:

1. Individuals suffering from any unstable medical condition precluding the use of NRT
(Identified using the Medical History Questionnaire given at baseline)

2. Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS),
nicotine replacement therapy, or other smoking cessation treatment

3. Pregnant or nursing

4. Suffering from a severe psychiatric disorder (assessed using self-reporting history of
psychiatric diagnosis during the phone screening) that would interfere with
participation

5. Diagnosis of substance dependence other than nicotine (screened using DSM IV TR
criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition

6. Individuals that do not have access to a working telephone