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NCT00799669 Clinical Trial

Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Head and Neck Cancer Clinical Trial

Official title:
Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00799669
Other study ID # CDR0000626365
Secondary ID MDA-2005-0791CDR
Status Active, not recruiting
Phase
First received
Last updated
Start date December 5, 2007
Est. completion date February 2020

Study information
Verified date November 2018
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 370
Est. completion date February 2020
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• preventive intervention

• questionnaire administration

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Participant At-risk drinking status 52 weeks
Primary Smoking cessation 52 weeks
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