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Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00799669
First received: November 27, 2008
Last updated: February 24, 2017
Last verified: February 2017
  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
Head and Neck Cancer Tobacco Use Disorder Behavioral: smoking cessation intervention Other: counseling intervention Other: preventive intervention Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participant At-risk drinking status [ Time Frame: 52 weeks ]
  • Smoking cessation [ Time Frame: 52 weeks ]

Estimated Enrollment: 370
Actual Study Start Date: February 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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 Other: questionnaire administration
Other Name: survey
MAPS

MAPS (Motivation and Problem-Solving):

Counseling treatment approach with a focus on smoking cessation.

Behavioral: smoking cessation intervention
Standard quit-smoking counseling to help decrease their risk of cancer.
Other: questionnaire administration
Other Name: survey

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Smokers Residing in Puerto Rico
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: David Wetter, PhD, MS, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00799669     History of Changes
Other Study ID Numbers: CDR0000626365
MDA-2005-0791
CDR0000626365 ( Other Identifier: NCI Clinical Trials )
U54CA096300 ( US NIH Grant/Contract Award Number )
U54CA096297 ( US NIH Grant/Contract Award Number )
NCI-2012-02110 ( Registry Identifier: NCI CTRP )
Study First Received: November 27, 2008
Last Updated: February 24, 2017

Keywords provided by M.D. Anderson Cancer Center:
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
tobacco use disorder

Additional relevant MeSH terms:
Head and Neck Neoplasms
Tobacco Use Disorder
Neoplasms by Site
Neoplasms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017