Clinical trial NCT00799669: Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
Official title: Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Tobacco Use Disorder
Keywords: hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
tobacco use disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-01
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Smokers Residing in Puerto Rico

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Participant At-risk drinking status
timeFrame: 52 weeks
measure: Smoking cessation
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Wetter, PhD, MS, BA
role: STUDY_CHAIR
References: