CClinicalTrials.gg
Status unknownNCT00799669Updated Nov 8, 2018

Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

An observational study in Head and Neck Cancer and Tobacco Use Disorder, sponsored by M.D. Anderson Cancer Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-08.

Sponsored by M.D. Anderson Cancer Center · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
370
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Head and Neck Cancer
  • Tobacco Use Disorder

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Keywords

  • hypopharyngeal cancer
  • laryngeal cancer
  • lip and oral cavity cancer
  • nasopharyngeal cancer
  • oropharyngeal cancer
  • paranasal sinus and nasal cavity cancer
  • tobacco use disorder
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In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's planned enrollment of 370 is above the median of 128 across 74 observational studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult Smokers Residing in Puerto Rico

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
370 participants (estimated)

Groups and cohorts

  • 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.

    Behavioral: smoking cessation intervention · Other: counseling intervention · Other: preventive intervention · Other: questionnaire administration

  • MAPS

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

    Behavioral: smoking cessation intervention · Other: questionnaire administration

Interventions

  • Behavioralsmoking cessation intervention

    Standard quit-smoking counseling to help decrease their risk of cancer.

  • Othercounseling intervention

    Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.

  • Otherpreventive intervention
  • Otherquestionnaire administration

    Also known as: survey

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What researchers measure

Primary outcomes

  1. Participant At-risk drinking status

    Time frame: 52 weeks

  2. Smoking cessation

    Time frame: 52 weeks

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00799669
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 1, 2008
Start date
Dec 5, 2007
Primary completion
Feb 2020 (estimated)
Completion
Feb 2020 (estimated)
Last update
Nov 8, 2018

Study contacts

David Wetter, PhD, MS, BA
study chair · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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