Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00799669
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2008-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2008-11-27', 'studyFirstSubmitQcDate': '2008-11-27', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant At-risk drinking status', 'timeFrame': '52 weeks'}, {'measure': 'Smoking cessation', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypopharyngeal cancer', 'laryngeal cancer', 'lip and oral cavity cancer', 'nasopharyngeal cancer', 'oropharyngeal cancer', 'paranasal sinus and nasal cavity cancer', 'tobacco use disorder'], 'conditions': ['Head and Neck Cancer', 'Tobacco Use Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Official Website'}, {'url': 'http://www.cancer.gov/about-cancer/treatment/clinical-trials/search?', 'label': 'National Cancer Institute (NCI) Central Website for Cancer Research'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and drinking works in preventing oral cancer in smokers in Puerto Rico.', 'detailedDescription': 'OBJECTIVES:\n\n* 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).\n* 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.\n* To evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.\n\nOUTLINE: 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.\n\n* 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.\n* 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Smokers Residing in Puerto Rico', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Current daily smoker\n* Called the Puerto Rico Quitline\n* Motivated to quit smoking in the next 30 days\n* Exhibits at least one of the following criteria for at-risk drinking:\n\n * An average of ≥ 2 alcoholic beverages/day for men or ≥ 1 drink/day for women in the past 30 days\n * Two or more occasions of consuming ≥ 5 alcoholic beverages/day for men or ≥ 4 drinks/day for women in the past 30 days\n * Driving after consuming ≥ 3 drinks in the past 30 days\n* Score of ≤ 15 on the Alcohol Use Disorders Identification Test\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant\n* Residing in Puerto Rico\n* Not currently incarcerated or in jail\n* No other household member enrolled in this study\n* Viable telephone number and home address\n* Willing to provide the names, addresses, and phone numbers of up to 3 collaterals\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00799669', 'briefTitle': 'Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use', 'orgStudyIdInfo': {'id': 'CDR0000626365'}, 'secondaryIdInfos': [{'id': 'MDA-2005-0791'}, {'id': 'CDR0000626365', 'type': 'OTHER', 'domain': 'NCI Clinical Trials'}, {'id': 'U54CA096300', 'link': 'https://reporter.nih.gov/quickSearch/U54CA096300', 'type': 'NIH'}, {'id': 'U54CA096297', 'link': 'https://reporter.nih.gov/quickSearch/U54CA096297', 'type': 'NIH'}, {'id': 'NCI-2012-02110', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MAPS+', 'description': 'MAPS+ (Motivation and Problem-Solving Plus):\n\nCounseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use.', 'interventionNames': ['Behavioral: smoking cessation intervention', 'Other: counseling intervention', 'Other: preventive intervention', 'Other: questionnaire administration']}, {'label': 'MAPS', 'description': 'MAPS (Motivation and Problem-Solving):\n\nCounseling treatment approach with a focus on smoking cessation.', 'interventionNames': ['Behavioral: smoking cessation intervention', 'Other: questionnaire administration']}], 'interventions': [{'name': 'smoking cessation intervention', 'type': 'BEHAVIORAL', 'description': 'Standard quit-smoking counseling to help decrease their risk of cancer.', 'armGroupLabels': ['MAPS', 'MAPS+']}, {'name': 'counseling intervention', 'type': 'OTHER', 'description': 'Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.', 'armGroupLabels': ['MAPS+']}, {'name': 'preventive intervention', 'type': 'OTHER', 'armGroupLabels': ['MAPS+']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'otherNames': ['survey'], 'armGroupLabels': ['MAPS', 'MAPS+']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Wetter, PhD, MS, BA', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}