Overview

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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
smoking cessation intervention
Standard quit-smoking counseling to help decrease their risk of cancer.
counseling intervention
Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.
preventive intervention
questionnaire administration survey
MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation.
smoking cessation intervention
Standard quit-smoking counseling to help decrease their risk of cancer.
questionnaire administration survey

Primary Outcomes

Measure
Participant At-risk drinking status
time frame: 52 weeks
Smoking cessation
time frame: 52 weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.