Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

M.D. Anderson Cancer Center

Status: Unknown

Conditions: Tobacco Use Disorder; Head and Neck Cancer

Treatments: Other: preventive intervention; Other: questionnaire administration; Behavioral: smoking cessation intervention; Other: counseling intervention

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00799669

NCI-2012-02110 (Registry Identifier)

U54CA096297 (U.S. NIH Grant/Contract)

MDA-2005-0791

CDR0000626365 (Other Identifier)

U54CA096300 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

370 participants in 2 patient groups

MAPS+

Description:

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.

Treatment:

Other: preventive intervention

Other: questionnaire administration

Behavioral: smoking cessation intervention

Other: counseling intervention

MAPS

Description:

MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation.

Treatment:

Other: questionnaire administration

Behavioral: smoking cessation intervention