Treatment to Stop Smoking and Drinking in Smokers in Puerto Rico - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00799669

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Head and Neck Cancer	Procedure: counseling Procedure: preventive intervention Procedure: questionnaire administration Procedure: smoking cessation intervention

MedlinePlus related topics: Cancer Head and Neck Cancer Quitting Smoking Smoking

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Observational
Official Title:	Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

At-risk drinking status [ Designated as safety issue: No ]
Smoking cessation [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2009
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To evaluate the effects of a motivation and problem-solving (MAPS) approach with a focus on smoking cessation with versus without a focus on the reduction of at-risk alcohol use (MAPS+) approach among Puerto Rican smokers who are at risk drinkers and 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Current smokers
- 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 (i.e., relatives/friends) who can provide information on the participant's whereabouts during the study

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799669

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David W. Wetter, PhD

M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	M. D. Anderson Cancer Center at University of Texas ( David W. Wetter )
Study ID Numbers:	CDR0000626365, MDA-2005-0791
Study First Received:	November 27, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00799669
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer

oropharyngeal cancer
paranasal sinus and nasal cavity cancer
tobacco use disorder

Study placed in the following topic categories:

Smoking
Nasopharyngeal carcinoma
Oral cancer
Tobacco Use Disorder
Head and Neck Neoplasms
Laryngeal carcinoma

Hypopharyngeal cancer
Laryngeal Neoplasms
Alcohol Drinking
Lip and oral cavity cancer
Ethanol

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009