Trial Information

Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Participants for this study will be recruited mainly through media advertisements (such as
TV, radio, newspapers, magazines, etc.).

If you are interested in participating in this study, you will be asked to provide
demographic information, such as your name, telephone number, and address. You will then be
mailed a packet, which will include a copy of this informed consent document, self-help
reading materials, and a guide to answering the questionnaires.

Within about 2 weeks after you have received your packet, you will be interviewed by a
research staff member by phone. You will be given detailed information about this study as
part of the consent process. This is a telephone counseling study. Please read this copy
of the consent very carefully. When the research staff member calls you in about 2 weeks,
he or she will review this consent form with you. You should ask any questions you have
about the consent or the study, and discuss any concerns you have with the research staff
member. After discussing the consent and the study with the research staff member, you
will be asked if you have read and understood the consent, and asked if you agree to
participate in this study. Your consent to participate in this study will be tape recorded.
This is so researchers can verify (know) that you have freely consented to participating in
this study. You should keep this copy of the consent, and you may ask questions about it
and/or the study at any time.

If you agree to participate, you will then go over several questionnaires with the
interviewer. You may be asked questions about your living situation, mood, depression,
anxiety, sleeping habits, appetite, smoking and alcohol use habits, social status, finances,
job, physical activity, and support base (family and/or friends). Then a quit date will be
set as well as the first telephone counseling call. This interview may take a total of about
1 hour to complete.

After this interview, participants will be randomly picked (as in the toss of a coin) to be
in one of 2 groups. One group will receive standard quit-smoking counseling to help
decrease their risk of cancer. The other group will also receive counseling, which will
focus on decreasing the risk of getting cancer by decreasing smoking and alcohol use.

Your counselor will be contacting you to set up your first counseling call. You will receive
a total of 7 counseling calls. You will discuss the timing of the counseling calls with your
counselor based upon when it is felt to be most beneficial for you. Depending on which group
you are in, you will be counseled on strategies for quitting smoking and/or decreasing
alcohol use to help decrease your risk of cancer. These calls will take about 15 to 30
minutes each to complete.

At Weeks 12, 26 and 52, you will be interviewed by telephone by a research staff member, who
will cover the same information as before. These evaluation (assessment) calls will take
about 30 minutes each to complete. You will receive a total of 4 assessment phone calls.
You will receive a total of 11 calls (including the counseling and assessment calls) over
about a 12-month period of time.

Your counseling calls (not the assessment calls) will be tape recorded. You will be
reminded before each counseling call that it will be taped recorded. This is so researchers
can make sure that correct procedures are being followed. Only the study staff will be
allowed to listen to these tapes. Your identity will be kept secure and confidential.
These tapes will be erased when this study has ended.

Your participation in this study will be over after the assessment call at Week 52.

This is an investigational study. Up to 370 participant will take part in this multicenter
study. None will be enrolled at M. D. Anderson.