Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
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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 |
- Participant At-risk drinking status [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Smoking cessation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 370 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 2014 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00799669 History of Changes |
| Other Study ID Numbers: | CDR0000626365, MDA-2005-0791, CDR0000626365 |
| Study First Received: | November 27, 2008 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Alcohol Drinking Head and Neck Neoplasms Tobacco Use Disorder Drinking Behavior |
Neoplasms by Site Neoplasms Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013