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Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02596711
Enrollment
26
Registered
2015-11-04
Start date
2015-11-02
Completion date
2017-08-22
Last updated
2020-03-10

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

Conditions

Tobacco Use Cessation, Cancer Prevention

Keywords

Cancer Prevention, Tobacco Use Cessation, Nicotine Patch, NRT, Questionnaires, Surveys, Carbon Monoxide Test, CO, Health Education, Handouts, Pamphlets, Counseling sessions

Brief summary

The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.

Detailed description

Baseline Visit: If you agree to take part in this study, the following tests and procedures will be performed at the beginning of the study: * You will complete 10 questionnaires about your demographics (age, race, sex, and so on), medical history, smoking status, alcohol use, religion, how in control you feel of your own life, and cultural background. These should take about 1½ hours to complete. * You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body. This test involves blowing your breath through a hand-held device. * You will learn how to keep a diary about your progress in your attempts to quit smoking. °You must bring this diary with you to every visit. * You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance. * If you can become pregnant, you will have a urine pregnancy test. To take part in this study, you must not be pregnant.3 * The total length of the baseline visit will be approximately 2.5 hours. Study Groups: You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will have an equal chance of being in each group. This is done because no one knows if one study group is better, the same, or worse than the other group. Counseling Sessions: The study group that you are in will determine the way that health information is presented to you in one-on-one counseling sessions. * If you are in Group 1, you will receive general health education. The counselor will discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to you and your smoking. The counselor will also give you handouts about the health topic. * If you are in Group 2, you and the counselor will discuss how your smoking and your culture may relate to each other. The counselor will also provide you with reading materials that highlight how aspects of your culture relate to health, smoking and quitting. * If you are in Group 3, you will receive the same cultural counseling and handouts that Group 2 received. Also, you will have additional talks about the use of drugs to help you stop smoking and some common feelings that Latinos may experience with being unsuccessful when trying to quit. The counselor will also offer you a plan for using medication successfully. All participants will attend 3 counseling sessions during the study. Each of these counseling sessions will be audio recorded. Your first counseling session will be at baseline. The other two counseling sessions will be at your Week 2 and Week 6 visits (described below). All participants will be given a 12 week supply of nicotine patches and information about how to use the nicotine patch. At each study visit, you will be given the amount of patches that you need to last you to your next visit, plus a few extra in the event that a patch falls off or is damaged. During your first counseling session, you will be asked to choose a quit date. This is simply a date that you would like to begin using the patch and make an attempt to not smoke. Week 2 and Week 6 Study Visits: At each of these study visits, all participants will have the following procedures: * You will complete a brief interview about your progress and any side effects you may be having. This should take about 10 minutes to complete. * You will complete 2 questionnaires about your tobacco use and satisfaction with the study. These should take about 10 minutes to complete. * You will complete a CO test. * You will be asked if you have smoked any other substances, such as marijuana, in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance. Follow-Up Visits: About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these visits, the following tests and procedures will be performed: * You will complete the same set of questionnaires about your tobacco and alcohol use, culture, religion, and sense of control that you did at your baseline visit. * You will complete a CO test. * You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance. Length of Study: Your study participation will be over after you complete the 6-month follow-up visit. This is an investigational study. Up to 36 people will be enrolled in this study. All will take part at MD Anderson.

Interventions

DRUGNicotine Patch

Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.

BEHAVIORALQuestionnaires

Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.

OTHERCarbon Monoxide (CO) Test

Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.

BEHAVIORALHealth Education and Handouts

Participants receive general health education and handouts.

BEHAVIORALCulturally Tailored Reading Materials

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.

Participants attend 3 counseling sessions during the study.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Adults at least 18 years of age 2. Current smoker (\>5 cigarettes per day for the past 3 months) 3. Able to speak and read English or Spanish 4. Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up 5. Willing to set a quit date within 2 weeks of enrollment date 6. Identify as being of Latino heritage, ethnicity, or ancestry

Exclusion criteria

1. Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline) 2. Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment 3. Pregnant or nursing 4. Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation 5. Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition 6. Individuals that do not have access to a working telephone

Design outcomes

Primary

MeasureTime frameDescription
Intervention Feasibility & AcceptabilityAveraged across 3 study visits (Week 0 to Week 12)The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = Extremely Unsatisfied to 5 = Extremely Satisfied). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Patch Adherence: Percentage of Days With PatchThis outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.
Number of Abstinent ParticipantsCollected at the 3- and 6-month follow-up visitsRates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from the Houston metropolitan area (Harris County, Texas) through fliers at community centers and local health clinics as well as through advertisements online and in print newspapers between February of 2016 and January of 2017.

Pre-assignment details

During baseline visit (prior to randomization), an expired carbon monoxide sample was collected using Bedfont Micro+Smokerlyzer.Additionally, participants able to become pregnant were required to take a routine hCG urine sample pregnancy test to rule out potential pregnancy.An assessment battery was also administered at the baseline visit.

Participants by arm

ArmCount
Health Education (HE)
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
9
Culturally-Tailored (CT)
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
8
Culturally-Tailored With Adherence Enhancement (CT+AE)
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
8
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up123

Baseline characteristics

CharacteristicHealth Education (HE)Culturally-Tailored (CT)Culturally-Tailored With Adherence Enhancement (CT+AE)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
9 Participants8 Participants8 Participants25 Participants
Age, Continuous45.4 years
STANDARD_DEVIATION 11
46 years
STANDARD_DEVIATION 10.94
40.7 years
STANDARD_DEVIATION 13.92
44.1 years
STANDARD_DEVIATION 11.53
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants8 Participants8 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants2 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants3 Participants6 Participants
Race (NIH/OMB)
White
8 Participants2 Participants3 Participants13 Participants
Region of Enrollment
United States
9 Participants8 Participants8 Participants25 Participants
Sex: Female, Male
Female
4 Participants3 Participants3 Participants10 Participants
Sex: Female, Male
Male
5 Participants5 Participants5 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 80 / 8
other
Total, other adverse events
3 / 91 / 80 / 8
serious
Total, serious adverse events
0 / 90 / 80 / 8

Outcome results

Primary

Intervention Feasibility & Acceptability

The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = Extremely Unsatisfied to 5 = Extremely Satisfied). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.

Time frame: Averaged across 3 study visits (Week 0 to Week 12)

ArmMeasureValue (MEAN)Dispersion
Health Education (HE)Intervention Feasibility & Acceptability4.87 score on a scaleStandard Deviation 0.35
Culturally-Tailored (CT)Intervention Feasibility & Acceptability4.71 score on a scaleStandard Deviation 0.48
Culturally-Tailored With Adherence Enhancement (CT+AE)Intervention Feasibility & Acceptability4.83 score on a scaleStandard Deviation 0.4
Primary

Number of Abstinent Participants

Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.

Time frame: Collected at the 3- and 6-month follow-up visits

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Health Education (HE)Number of Abstinent Participants3-month follow-up4 Participants
Health Education (HE)Number of Abstinent Participants6-month follow-up4 Participants
Culturally-Tailored (CT)Number of Abstinent Participants6-month follow-up2 Participants
Culturally-Tailored (CT)Number of Abstinent Participants3-month follow-up2 Participants
Culturally-Tailored With Adherence Enhancement (CT+AE)Number of Abstinent Participants3-month follow-up4 Participants
Culturally-Tailored With Adherence Enhancement (CT+AE)Number of Abstinent Participants6-month follow-up3 Participants
Primary

Patch Adherence: Percentage of Days With Patch

Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.

Time frame: This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.

ArmMeasureValue (MEAN)Dispersion
Health Education (HE)Patch Adherence: Percentage of Days With Patch64.6 percentage of NRT patch daysStandard Deviation 17.7
Culturally-Tailored (CT)Patch Adherence: Percentage of Days With Patch68.6 percentage of NRT patch daysStandard Deviation 13.66
Culturally-Tailored With Adherence Enhancement (CT+AE)Patch Adherence: Percentage of Days With Patch81.3 percentage of NRT patch daysStandard Deviation 3.32

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026