Determinants of Smoking Cessation Among Latinos

NCT01008748 | Completed Results

• 2 other identifiers: 2007-04422P60MD000503-05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn how neighborhood and individual factors affect the ability to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit smoking.

Conditions

Smoking Cessation

Keywords

Smoking; Latinos; Mexican American; Spanish-speaking smokers; Ecological momentary assessment; Nicotine patch; Smoking cessation counseling; Questionnaire; EMA

Outcome Measures

Primary Outcomes (9)

• Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)

  Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.

  Week 3 post quit day

• 24-Hour Smoking Abstinence (Week 26 Post Quit Day)

  Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.

  Week 26 post quit day

• 7-Day Smoking Abstinence (Week 3 Post Quit Day)

  Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

  Week 3 post quit day

• 7-Day Smoking Abstinence (Week 26 Post Quit Day)

  Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

  Week 26 post quit day

• 30-Day Smoking Abstinence (Week 26 Post Quit Day)

  Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.

  Week 26 post quit day

• 7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat

  Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

  Week 3 post quit day

• 7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat

  Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

  Week 26 post quit day

• 7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence

  Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach

  Week 3 post quit day

• 7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence

  Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach

  Week 26 post quit day

Study Arms (1)

Smoking Cessation Treatment

EXPERIMENTAL

Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.

Drug: Nicotine Replacement Therapy (NRT); Behavioral: Questionnaire; Behavioral: Counseling; Behavioral: Self-Help Materials

Interventions

Nicotine Replacement Therapy (NRT) DRUG

NRT for participants who smoke \>10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits.

Also known as: Nicotine Patch Therapy

Smoking Cessation Treatment

Questionnaire BEHAVIORAL

Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.

Also known as: Survey

Smoking Cessation Treatment

Counseling BEHAVIORAL

Each counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish.

Smoking Cessation Treatment

Self-Help Materials BEHAVIORAL

Spanish-language self-help materials currently used by the NCI's Cancer Information Service.

Also known as: pamphlets

Smoking Cessation Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current daily smoker who average \>/= 5 cigarettes/day for the last year
• Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community
• Age 18 to 65 years
• Motivated to quit smoking in the next 30 days
• Viable (working) telephone number and home address
• Prefers to speak in Spanish
• Register "8" or more on a carbon monoxide breath test

You may not qualify if:

• Contraindication for nicotine patch use
• Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
• Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
• Pregnancy or lactation
• Currently enrolled in a smoking cessation program
• Participation in a smoking cessation program or study during the past 90 days
• Another household member is enrolled in this protocol
• Active substance abuse problem

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Department of Health and Human Services: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Vinci C, Cambron C, Lam C, Wetter DW. Perceived discrimination and smoking lapse among Mexican Americans: An ecological momentary assessment study. Health Psychol. 2021 Jun;40(6):388-397. doi: 10.1037/hea0001093.

  PMID: 34323541 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Nicotine Replacement Therapy; Surveys and Questionnaires; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Sharon Giordano, MD/Chair, Health Svcs Research-Clinical
• Organization: UT MD Anderson Cancer Center - Clinical Research Operations

sgiordan@mdanderson.org

713-563-0020

Study Officials

• David Wetter, PhD, MS, BA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: November 6, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Locations

US (1)