Determinants of Smoking Cessation Among Latinos

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01008748

Enrollment

200

Registered

2009-11-06

Start date

2009-09-30

Completion date

2016-09-30

Last updated

2020-03-19

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

Conditions

Smoking Cessation

Keywords

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

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.

Detailed description

If you agree to take part in this study, you will receive treatment to help you quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Over the next 6 months, you will visit M. D. Anderson 5 times during this study. You will also be called 3 times for smoking cessation counseling during this study. Study Visits: First (Orientation) Visit You will be asked about your feelings and moods, as well as how many cigarettes you smoke. You will fill out questionnaires on a computer. The questionnaires will be about your mood, stress level, and smoking-related issues. They should take about 1 hour and 30 minutes to complete. You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale. You will give two saliva samples at this visit. To collect the first saliva sample, you will place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check the amount of cotinine in the body. Cotinine is a chemical that is produced in your saliva when your body breaks down nicotine. The second saliva sample will be collected by spitting into a container. Researchers will perform genetic tests with these samples to look for genes that control the production and use of neurotransmitters, naturally occurring chemical messengers in the brain. People with certain genes may have a more difficult time quitting smoking, because of the way nicotine affects these chemicals. Your second saliva sample will be stored in a biorepository at M. D. Anderson for use in future research related to nicotine addiction, smoking, and/or cancer. Your saliva sample will be placed in a bank of biological samples and data that is available to researchers conducting research related to cancer or nicotine dependence. Before your saliva sample can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of M. D. Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at M. D. Anderson, including research involving your saliva sample from this bank, must first be approved by the IRB. Your samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. Other researchers using your samples will not be able to link this data to you. Genetic information obtained will not be provided to you. Second (Baseline) Visit: Your second visit (Baseline) will occur 1 week before your Quit date visit. You will fill out questionnaires on a computer. The questionnaires will be about your, stress level, social support and smoking-related issues. They should take about 1 hour and 30 minutes to complete. You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale. Your Height, Weight and Waist circumference measures will be taken. You will also receive individual counseling. During counseling, you will discuss techniques to help you quit smoking. In addition, you will receive a small, hand-held personal computer and be trained in how to use it. You will carry this computer with you for 4 weeks. You will use the computer to answer questions about your mood, stress, and smoking-related issues. You will be asked to fill out some questions on the computer each time you have an urge to smoke or you actually smoke. Also, the computer will beep at random and set times and request that you answer some questions. This computer will not wake you during the night and you will be able to wait to answer questions for a few minutes if it goes off when you are busy. Answering the questions should take about 5 to 10 minutes. Third (Quit Day) and Fourth (Week 3) Study Visits: Your Third visit (Quit Day) will occur 1 week after your Second (Baseline) visit. Your Fourth visit will occur 3 weeks after your Quit Day. During these visits, you will be asked to fill out questionnaires on a computer about your moods and feelings, as well as how many cigarettes you smoke. The questionnaires should take about 30 minutes to complete. You will also receive individual counseling. During counseling, you will discuss techniques to help you quit smoking. On your Third visit, you will complete the breath test and your Weight and Waist circumference measures will also be taken. At your Third visit you will be given a supply of nicotine patches to last until your Fourth visit. At your Fourth visit you will be given a one week supply of nicotine patches. You will be on nicotine patches for a total of 4 weeks. At the Fourth Visit, you will also complete the breath test, will give a saliva sample and your Weight and Waist circumference measures will be taken. Last (Week 26) Visit: This visit will occur 26 weeks (or 6 months) after your Quit Day. During these visits, you will be asked to fill out questionnaires on a computer about your moods and feelings, as well as how many cigarettes you smoke. The questionnaires should take about 1 1/2 hours to complete. You will complete the breath test, your Weight and Waist circumference measures will be taken and you will also give a saliva sample at the last (Week 26) visit. Telephone Calls: Between your first (Orientation) visit and your Fourth (Week 3) visit, you will receive 3 calls from a smoking cessation counselor. You will receive your first call a few days before your quit day. You will receive a second call 1 week after your Quit Day and another call 2 weeks after your Quit Day. During these calls, you will discuss techniques to help you quit smoking. These calls will last 10 to 15 minutes and will be scheduled in advance. Additional Information: You may be contacted by mail, telephone, and/or e-mail throughout the study to remind you about clinic visits. You may also be asked for information about your smoking status during the usual reminder calls and/or calls to reschedule missed appointments. Length of Study: You will be considered off study when you complete the Week 26 (or Last) visit. This is an investigational study. The nicotine patch is FDA approved and commercially available. Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.

Interventions

DRUGNicotine Replacement Therapy (NRT)

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.

BEHAVIORALQuestionnaire

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

BEHAVIORALCounseling

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.

BEHAVIORALSelf-Help Materials

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Current daily smoker who average \>/= 5 cigarettes/day for the last year 2. Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community 3. Age 18 to 65 years 4. Motivated to quit smoking in the next 30 days 5. Viable (working) telephone number and home address 6. Prefers to speak in Spanish 7. Register 8 or more on a carbon monoxide breath test

Exclusion criteria

1. Contraindication for nicotine patch use 2. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco) 3. Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study 4. Pregnancy or lactation 5. Currently enrolled in a smoking cessation program 6. Participation in a smoking cessation program or study during the past 90 days 7. Another household member is enrolled in this protocol 8. Active substance abuse problem

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)	Week 3 post quit day	Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
24-Hour Smoking Abstinence (Week 26 Post Quit Day)	Week 26 post quit day	Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 3 Post Quit Day)	Week 3 post quit day	Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 26 Post Quit Day)	Week 26 post quit day	Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
30-Day Smoking Abstinence (Week 26 Post Quit Day)	Week 26 post quit day	Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat	Week 3 post quit day	Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat	Week 26 post quit day	Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence	Week 3 post quit day	Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence	Week 26 post quit day	Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach

Countries

United States

Participant flow

Recruitment details

Recruitment Period: September 2009 and September 2016. Participants were recruited from the Mexican-American Cohort study and from Houston area.

Participants by arm

Arm	Count
Smoking Cessation Treatment NRT, self-help materials + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits.	200
Total	200

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	80
Overall Study	Other	1

Baseline characteristics

Characteristic	Smoking Cessation Treatment
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	200 Participants
Age, Continuous	38.6 years STANDARD_DEVIATION 10.1
Demographics (Education) < High School	116 Participants
Demographics (Education) High School/GED	39 Participants
Demographics (Education) Refused to Answer	1 Participants
Demographics (Education) Some College	28 Participants
Demographics (Education) Some kind of degree (Voc/AA/BS and up)	16 Participants
Demographics (Employment Status) Employed	135 Participants
Demographics (Employment Status) Refused to Answer	2 Participants
Demographics (Employment Status) Unemployed	63 Participants
Demographics (Household Income) <$12,000	30 Participants
Demographics (Household Income) $12,001 - $30,000	68 Participants
Demographics (Household Income) $30,001 - $54,000	54 Participants
Demographics (Household Income) > $54,001/year	20 Participants
Demographics (Household Income) Refused to Answer	28 Participants
Demographics (Spouse/Partner) No partner	61 Participants
Demographics (Spouse/Partner) Partner	138 Participants
Demographics (Spouse/Partner) Refused to Answer	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	200 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Nicotine Dependence - Cigarettes per day <=10	74 Participants
Nicotine Dependence - Cigarettes per day 11-19	53 Participants
Nicotine Dependence - Cigarettes per day >=20	70 Participants
Nicotine Dependence - Cigarettes per day Refused to Answer	3 Participants
Nicotine Dependence - Participants reported smoking their first cigarette with 5 minutes of walking	64 Participants
Region of Enrollment United States	200 participants
Sex: Female, Male Female	74 Participants
Sex: Female, Male Male	126 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 200
other Total, other adverse events	0 / 200
serious Total, serious adverse events	0 / 200

Outcome results

Primary

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

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