Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
RATIONALE: A counseling program that motivates patients to stop smoking and drinking may reduce the risk of oral cancer. It is not yet known whether motivational stop smoking counseling or motivational stop-smoking and stop drinking counseling is more effective in helping patients stop smoking and drinking.
PURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and drinking works in preventing oral cancer in smokers in Puerto Rico.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- To evaluate the effects of a motivational and problem-solving smoking cessation (MAPS) and a motivational and problem solving approach on at-risk alcohol use and smoking cessation (MAPS+) among Puerto Rican at-risk drinkers/smokers who call the Puerto Rico Quitline (PRQ).
- To assess effects of MAPS and MAPS+ on treatment mechanisms and the role of those mechanisms in mediating these effects on at-risk drinking and smoking cessation.
- To evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
OUTLINE: Minimization randomization is applied using the following variables: age, gender, cigarettes/day, number of drinks/day, and depression (score on the Center of Epidemiologic Studies Depression Scale). Patients are randomized to 1 of 2 intervention arms.
- Arm I (MAPS): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS approach includes motivational interviewing and cognitive behavioral/problem-solving that focus on smoking cessation.
- Arm II (MAPS+): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS+ approach includes motivational interviewing and cognitive behavioral/problems solving that focus on smoking cessation and the reduction of at-risk alcohol use.
In both arms, patients receive counseling calls over 15-30 minutes the week before quit date (QD), on QD, 3-5 days after QD, 7-10 days after QD, 15-30 days after QD, 45-60 days after QD, and on day 90 after QD. Patients complete questionnaires for alcohol- and smoking-related measures, self efficacy, stress/negative affects/depression, social support, and physical activity at baseline and weeks 12, 26 and 52 after QD.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Current daily smoker
- Called the Puerto Rico Quitline
- Motivated to quit smoking in the next 30 days
Exhibits at least one of the following criteria for at-risk drinking:
- An average of ≥ 2 alcoholic beverages/day for men or ≥ 1 drink/day for women in the past 30 days
- Two or more occasions of consuming ≥ 5 alcoholic beverages/day for men or ≥ 4 drinks/day for women in the past 30 days
- Driving after consuming ≥ 3 drinks in the past 30 days
- Score of ≤ 15 on the Alcohol Use Disorders Identification Test
PATIENT CHARACTERISTICS:
- Not pregnant
- Residing in Puerto Rico
- Not currently incarcerated or in jail
- No other household member enrolled in this study
- Viable telephone number and home address
- Willing to provide the names, addresses, and phone numbers of up to 3 collaterals
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
Other Names:
Standard quit-smoking counseling to help decrease their risk of cancer.
Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.
|
|
MAPS
MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation. |
Other Names:
Standard quit-smoking counseling to help decrease their risk of cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Smoking cessation
Time Frame: 52 weeks
|
52 weeks
|
|
Participant At-risk drinking status
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: David Wetter, PhD, MS, BA, M.D. Anderson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000626365 (Other Identifier: NCI Clinical Trials)
- U54CA096300 (U.S. NIH Grant/Contract)
- U54CA096297 (U.S. NIH Grant/Contract)
- NCI-2012-02110 (Registry Identifier: NCI CTRP)
- MDA-2005-0791
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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