Trial Outcomes & Findings for Determinants of Smoking Cessation Among Latinos (NCT NCT01008748)

NCT ID: NCT01008748

Last Updated: 2020-03-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

Week 3 post quit day

Results posted on

2020-03-19

Participant Flow

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

Participant milestones

Participant milestones
Measure	Smoking Cessation Treatment 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions in 26 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
Overall Study STARTED	200
Overall Study Baseline	188
Overall Study Week 0	182
Overall Study Week 3	168
Overall Study Week 26	119
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Smoking Cessation Treatment 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions in 26 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
Overall Study Lost to Follow-up	80
Overall Study Other	1

Baseline Characteristics

Determinants of Smoking Cessation Among Latinos

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: Week 3 post quit day

Population: Completers-Only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=168 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)	100 Participants

PRIMARY outcome

Timeframe: Week 26 post quit day

Population: Completers -only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=119 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
24-Hour Smoking Abstinence (Week 26 Post Quit Day)	41 Participants

PRIMARY outcome

Timeframe: Week 3 post quit day

Population: Completers-only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=168 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
7-Day Smoking Abstinence (Week 3 Post Quit Day)	76 Participants

PRIMARY outcome

Timeframe: Week 26 post quit day

Population: Completers only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=119 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
7-Day Smoking Abstinence (Week 26 Post Quit Day)	33 Participants

PRIMARY outcome

Timeframe: Week 26 post quit day

Population: Completers only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=119 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
30-Day Smoking Abstinence (Week 26 Post Quit Day)	28 Participants

PRIMARY outcome

Timeframe: Week 3 post quit day

Population: Continuous Abstinence Intent-to-treat

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=200 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat	57 Participants

PRIMARY outcome

Timeframe: Week 26 post quit day

Population: Continuous Abstinence Intent-to-treat

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=200 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat	20 Participants

PRIMARY outcome

Timeframe: Week 3 post quit day

Population: Continuous Abstinence Completers-only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=168 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence	57 Participants

PRIMARY outcome

Timeframe: Week 26 post quit day

Population: Continuous Abstinence Completers-only

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

Outcome measures

Outcome measures
Measure	Smoking Cessation Treatment n=119 Participants 6 wks of nicotine patch therapy, self-help guide and in-person/telephone individual counseling (6 sessions within 3 weeks of Quit date) based on Tobacco Use and Dependence Clinical Practice Guideline
7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence	20 Participants

Adverse Events

Smoking Cessation Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharon Giordano, MD/Chair, Health Svcs Research-Clinical

UT MD Anderson Cancer Center - Clinical Research Operations

Phone: 713-563-0020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place