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| ID | Type | Description | Link |
|---|---|---|---|
| MDA-2005-0791 | |||
| CDR0000626365 | Other Identifier | NCI Clinical Trials | |
| U54CA096300 | U.S. NIH Grant/Contract | View source | |
| U54CA096297 | U.S. NIH Grant/Contract | View source | |
| NCI-2012-02110 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| MAPS | MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking cessation intervention | Behavioral | Standard quit-smoking counseling to help decrease their risk of cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant At-risk drinking status | 52 weeks | |
| Smoking cessation | 52 weeks |
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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:
Score of ≤ 15 on the Alcohol Use Disorders Identification Test
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Adult Smokers Residing in Puerto Rico
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| Name | Affiliation | Role |
|---|---|---|
| David Wetter, PhD, MS, BA | M.D. Anderson Cancer Center | Study Chair |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
| National Cancer Institute (NCI) Central Website for Cancer Research | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014029 | Tobacco Use Disorder |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| counseling intervention | Other | Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use. |
|
| preventive intervention | Other |
|
| questionnaire administration | Other |
|
|
| D001523 |
| Mental Disorders |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D005159 | Health Care Facilities Workforce and Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |