Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

• Behavioral: smoking cessation intervention
• Other: counseling intervention
• Other: preventive intervention
• Other: questionnaire administration

Primary Measures

• At-risk drinking status
  • Safety Issue?: No
• Smoking cessation
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: M.D. Anderson Cancer Center Other

Overall Clinical Trial Officials and Contacts

Luz Mejia  M.D. Anderson Cancer Center  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00799669

Study ID Number: CDR0000626365

ClinicalTrials.gov Identifier: NCT00799669

Health Authority: Unspecified