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Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Tobacco Use Disorder

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Trial Information

Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Participant At-risk drinking status

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

David Wetter, PhD, MS, BA

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000626365

NCT ID:

NCT00799669

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Tobacco Use Disorder
  • hypopharyngeal cancer
  • laryngeal cancer
  • lip and oral cavity cancer
  • nasopharyngeal cancer
  • oropharyngeal cancer
  • paranasal sinus and nasal cavity cancer
  • tobacco use disorder
  • Alcohol Drinking
  • Head and Neck Neoplasms
  • Tobacco Use Disorder

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