Combined Treatment for Tobacco and Alcohol Use in Puerto Rico
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Smoking Cessation, Psychiatric |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | December 2007 |
| End Date: | December 2020 |
Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
Objectives:
1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
2. Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy,
decreased temptations/craving, decreased stress and negative affect) and the role of
those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and
smoking cessation.
3. Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking
and smoking cessation.
1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
2. Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy,
decreased temptations/craving, decreased stress and negative affect) and the role of
those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and
smoking cessation.
3. Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking
and smoking cessation.
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.
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.
Inclusion Criteria:
1. Current (daily) smoker requesting help for smoking cessation
2. Exhibit at least one of the following criteria for at-risk drinking: a) an average of
=/> 2 alcoholic beverages/day during the past 30 days for men or =/>1 drink/day for
women, OR b) two or more occasions of consuming /=> 5 alcoholic beverages during the
past 30 days for men or =/>4 drinks for women, OR c) in the past 30 days, driving
after consuming =/>3 drinks.
3. Age 18 or above
4. Motivated to quit smoking in the next 30 days
5. Viable (working) telephone number and home address
6. No other household member enrolled in this protocol
7. Residing in Puerto Rico
8. Must score less than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification
Test)
Exclusion Criteria:
1. Currently incarcerated or in jail
2. Currently pregnant
3. Score equal to or more than 16 on the Alcohol Use Disorders Identification Test
(AUDIT) measure.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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