Trial Information

Reducing Cancer Disparities Among Latinos in Texas

Day 1 Study Visit:

If you are found eligible to take part in this study, the following tests and procedures
will be performed on Day 1 (the same day you complete the screening tests and sign this
consent form):

- You will be asked to complete some computer-based questionnaires that will include
questions about your feelings, moods, and smoking status. These will take 60-90
minutes to complete.

- You will have your height, weight, and waistline measured.

- Your blood pressure will be measured by a trained research staff member

- You will complete a breath test to help researchers estimate (guess) the amount of
cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is
attached to a machine, and you will be asked to blow a long, slow, steady breath into
it.

- You will be given an accelerometer to wear for 7 days. An accelerometer is a small
device that is worn on the waistline of your pants that measures your level of physical
activity. After 7 days, you will be asked to "turn off" and mail back the
accelerometer using a prepaid envelope provided by the study staff.

- You will give a saliva sample at this visit. To collect the saliva sample, you will
place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check
the amount of cotinine in the body. Cotinine is a chemical that is produced in your
saliva when your body breaks down nicotine.

Study Groups and Study Procedures:

At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of
2 study groups. There is an equal chance of being assigned to either group.

Participants in both groups will receive health education on Day 1, and again 6 and 12
months later. You can also ask to receive a 6-week supply of nicotine patches, whenever you
are ready to try to quit smoking and a home-based exercise kit when you are ready to begin
an exercise program.

At the Day 1 health education session, the following will take place:

- You will have a brief counseling session with a study staff member to talk about
smoking, diet, and your physical activity level.

- You will be offered referrals to available resources for help with your smoking
cessation, diet, and physical activity.

- You will be given a home-based exercise kit, along with self-help materials that are
designed to help you learn how to quit smoking and how to improve your diet and
physical activity.

At the Months 6 and 12 health education sessions, the Day 1 activities will be repeated, and
the following procedures will also take place:

- You will complete a computer-based questionnaire about your mood, diet, and physical
activity. This will take 60-90 minutes to complete.

- Your weight and waistline will be measured.

- You will complete a breath test. The breath test uses a disposable cardboard tube that
is attached to a machine, and you will be asked to blow a long, slow, steady breath
into it.

- You will give a saliva sample. To collect the saliva sample, you will place a piece of
cotton in your mouth for 3 minutes. The saliva sample is used to check the amount of
cotinine in the body. Cotinine is a chemical that is produced in your saliva when your
body breaks down nicotine.

- You will be given an accelerometer to wear for 7 days. After 7 days, you will mail
back the accelerometer using a prepaid envelope provided by the study staff.

You will also have a follow-up study visit at Month 18. During this visit, the same
procedures from the Month 12 visit will be performed. However, you will not have a health
education session at Month 18.

Wellness Program:

In addition to the health education visits and materials, participants in Group 2 will also
take part in the wellness program. For the wellness program, you will receive 18 counseling
phone calls over the 18 months you are on study. Each of these phone calls should last
about 20-30 minutes.

The telephone counseling sessions will be digitally recorded. Audio recordings will be
erased once the data have been published. The recordings will be used to help the
researchers make sure that the counselors are following the correct procedures and may be
used in the future to help the researchers better understand or improve the counseling
treatment. No one but the researchers and their staff will be allowed to view or listen to
the recordings, and the identity of the participants will be kept strictly confidential.
Your study identification number will be stated by the counselor at the beginning of the
taped session. The recordings are stored digitally, encrypted, and password protected.

Questionnaire Data:

Your questionnaire data will be used for research purposes only. Your responses will not be
shared with your doctor. If you feel you need a doctor's opinion about anything that is
asked about in the questionnaires (such as mental or emotional difficulties or symptoms),
please contact either your personal doctor or the study chair.

Length of Study:

You will remain on the study for up to 18 months. Your participation on this part of the
study will be over once you complete the study visit at Month 18.

This is an investigational study. The nicotine patch is FDA approved and commercially
available. Up to 500 participants overall will take part in this research study. Up to 400
participants will take part in this portion of the study. All will be enrolled at MD
Anderson.