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Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00799669
Enrollment
370
Registered
2008-12-01
Start date
2007-12-05
Completion date
2020-02-29
Last updated
2018-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Tobacco Use Disorder

Keywords

hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, tobacco use disorder

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.

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.

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.

OTHERquestionnaire administration

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Participant At-risk drinking status52 weeks
Smoking cessation52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026