Combined Treatment for Tobacco and Alcohol Use in Puerto Rico

Tracking Information
First Submitted Date ICMJE	December 7, 2007
First Posted Date ICMJE	December 11, 2007
Last Update Posted Date	January 9, 2018
Actual Study Start Date ICMJE	December 2007
Estimated Primary Completion Date	December 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 8, 2009)	Continuous outcome variables (including number of drinks per day, self-efficacy, etc.) [ Time Frame: 2 Years ]
Original Primary Outcome Measures ICMJE; (submitted: December 7, 2007)	Develop a "Motivational Relapse Prevention" (MRP) approach to simultaneously treating both smoking and "at-risk" alcohol use among smokers. [ Time Frame: 2 Years ]
Change History	Complete list of historical versions of study NCT00570804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE; (submitted: December 7, 2007)	Assess MRP effects on alcohol at-risk behaviors. [ Time Frame: 2 Years ]; Assess MRP effects on treatment mechanisms (increased self-efficacy, decreased temptations/craving, decreased stress and negative affect) and the role of those mechanisms in mediating MRP effects on alcohol at-risk behaviors. [ Time Frame: 2 Years ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Combined Treatment for Tobacco and Alcohol Use in Puerto Rico
Official Title ICMJE	Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
Brief Summary	Objectives: Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.; 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.; Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Smoking
Intervention ICMJE	Behavioral: Telephone Counseling 7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.; Behavioral: Telephone Assessments 4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete. Other Names: Survey Questionnaire
Study Arms	MAPS+ MAPS+ (Motivation and Problem-Solving Plus): Counseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use. Interventions: Behavioral: Telephone Counseling Behavioral: Telephone Assessments; MAPS MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation. Interventions: Behavioral: Telephone Counseling Behavioral: Telephone Assessments
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: December 7, 2007)	370
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2020
Estimated Primary Completion Date	December 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Current (daily) smoker requesting help for smoking cessation; 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.; Age 18 or above; Motivated to quit smoking in the next 30 days; Viable (working) telephone number and home address; No other household member enrolled in this protocol; Residing in Puerto Rico; Must score less than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test) Exclusion Criteria: Currently incarcerated or in jail; Currently pregnant; Score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT) measure.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00570804
Other Study ID Numbers ICMJE	2005-0791; U54CA096300 ( U.S. NIH Grant/Contract ); U54CA096297 ( U.S. NIH Grant/Contract ); NCI-2012-02110 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	M.D. Anderson Cancer Center
Study Sponsor ICMJE	M.D. Anderson Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: David Wetter, PhD M.D. Anderson Cancer Center
PRS Account	M.D. Anderson Cancer Center
Verification Date	January 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP