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

NCT ID: NCT02596711

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-02
• Study Completion Date: 2017-08-22

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.

Conditions

Tobacco Use Cessation; Cancer Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Health Education (HE) Group

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).

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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

Questionnaires

Intervention Type: BEHAVIORAL

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.

Carbon Monoxide (CO) Test

Intervention Type: OTHER

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

Health Education and Handouts

Intervention Type: BEHAVIORAL

Participants receive general health education and handouts.

Counseling Sessions

Intervention Type: BEHAVIORAL

Participants attend 3 counseling sessions during the study.

Culturally Tailored Smoking Cessation (CTSC) Group

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).

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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

Questionnaires

Intervention Type: BEHAVIORAL

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.

Carbon Monoxide (CO) Test

Intervention Type: OTHER

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

Culturally Tailored Reading Materials

Intervention Type: BEHAVIORAL

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

Counseling Sessions

Intervention Type: BEHAVIORAL

Participants attend 3 counseling sessions during the study.

Culturally Tailored Smoking + Adherence Enhancement (AE) Group

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).

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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

Questionnaires

Intervention Type: BEHAVIORAL

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.

Carbon Monoxide (CO) Test

Intervention Type: OTHER

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

Culturally Tailored Reading Materials

Intervention Type: BEHAVIORAL

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

Counseling Sessions

Intervention Type: BEHAVIORAL

Participants attend 3 counseling sessions during the study.

Interventions

Nicotine Patch

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

Intervention Type: DRUG

Questionnaires

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.

Intervention Type: BEHAVIORAL

Carbon Monoxide (CO) Test

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

Intervention Type: OTHER

Health Education and Handouts

Participants receive general health education and handouts.

Intervention Type: BEHAVIORAL

Culturally Tailored Reading Materials

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

Intervention Type: BEHAVIORAL

Counseling Sessions

Participants attend 3 counseling sessions during the study.

Intervention Type: BEHAVIORAL

Other Intervention Names

NRT; Surveys; Pamphlets; Pamphlets

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcel A. de Dios, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30633744 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

K01CA160670

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2016-00193

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0585

Identifier Type: -

Identifier Source: org_study_id