Clinical trial NCT02596711: Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
Official title: Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Feasibility & Acceptability
timeFrame: Averaged across 3 study visits (Week 0 to Week 12)
measure: Patch Adherence: Percentage of Days With Patch
timeFrame: This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.
measure: Number of Abstinent Participants
timeFrame: Collected at the 3- and 6-month follow-up visits
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Marcel A. de Dios, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Dios MA, Cano MA, Vaughan EL, Childress SD, McNeel MM, Harvey LM, Niaura RS. A pilot randomized trial examining the feasibility and acceptability of a culturally tailored and adherence-enhancing intervention for Latino smokers in the U.S. PLoS One. 2019 Jan 11;14(1):e0210323. doi: 10.1371/journal.pone.0210323. eCollection 2019.