NCT00799669

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

12.2 years

First QC Date

November 27, 2008

Last Update Submit

November 7, 2018

Conditions

Head and Neck CancerTobacco Use Disorder

Keywords

hypopharyngeal cancerlaryngeal cancerlip and oral cavity cancernasopharyngeal canceroropharyngeal cancerparanasal sinus and nasal cavity cancertobacco use disorder

Outcome Measures

Primary Outcomes (2)

  • Participant At-risk drinking status

    52 weeks

  • Smoking cessation

    52 weeks

Study Arms (2)

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 interventionOther: counseling interventionOther: preventive interventionOther: questionnaire administration

MAPS

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

Behavioral: smoking cessation interventionOther: questionnaire administration

Interventions

smoking cessation interventionBEHAVIORAL

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

MAPSMAPS+
counseling interventionOTHER

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

MAPS+
preventive interventionOTHER
MAPS+
questionnaire administrationOTHER
Also known as: survey
MAPSMAPS+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Smokers Residing in Puerto Rico

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsTobacco Use DisorderHypopharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsNasopharyngeal NeoplasmsOropharyngeal Neoplasms

Interventions

CounselingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSubstance-Related DisordersChemically-Induced DisordersMental DisordersPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsMouth DiseasesNasopharyngeal Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Wetter, PhD, MS, BA

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2008

First Posted

December 1, 2008

Study Start

December 5, 2007

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

November 8, 2018

Record last verified: 2018-11