Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
This trial is active, not recruiting.
|Conditions||head and neck cancer, tobacco use disorder|
|Treatments||smoking cessation intervention, counseling intervention, preventive intervention, questionnaire administration|
|Sponsor||M.D. Anderson Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||February 2009|
|End date||December 2017|
|Trial size||370 participants|
|Trial identifier||NCT00799669, CDR0000626365, MDA-2005-0791, NCI-2012-02110, U54CA096297, U54CA096300|
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.
|Observational model||case control|
Participant At-risk drinking status
time frame: 52 weeks
time frame: 52 weeks
Male or female participants at least 18 years old.
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
|Official title||Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use|
|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.|
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