Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

November 7, 2018 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Smokers Residing in Puerto Rico

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MAPS+

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.
Other: questionnaire administration
Other Names:
  • survey
Behavioral: smoking cessation intervention
Standard quit-smoking counseling to help decrease their risk of cancer.
Other: counseling intervention
Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.
Other: preventive intervention
MAPS

MAPS (Motivation and Problem-Solving):

Counseling treatment approach with a focus on smoking cessation.
Other: questionnaire administration
Other Names:
  • survey
Behavioral: smoking cessation intervention
Standard quit-smoking counseling to help decrease their risk of cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Smoking cessation
Time Frame: 52 weeks
52 weeks
Participant At-risk drinking status
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David Wetter, PhD, MS, BA, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2007

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

November 27, 2008

First Submitted That Met QC Criteria

November 27, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000626365 (Other Identifier: NCI Clinical Trials)
  • U54CA096300 (U.S. NIH Grant/Contract)
  • U54CA096297 (U.S. NIH Grant/Contract)
  • NCI-2012-02110 (Registry Identifier: NCI CTRP)
  • MDA-2005-0791

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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