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

Study Overview
=================
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.

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

Conditions
-----------------
Tobacco Use Cessation, Cancer Prevention

Intervention / Treatment
-----------------
* Drug: Nicotine Patch
* Behavioral: Questionnaires
* Other: Carbon Monoxide (CO) Test
* Behavioral: Health Education and Handouts
* Behavioral: Culturally Tailored Reading Materials
* Behavioral: Counseling Sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults at least 18 years of age Current smoker (>5 cigarettes per day for the past 3 months) Able to speak and read English or Spanish Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up Willing to set a quit date within 2 weeks of enrollment date Identify as being of Latino heritage, ethnicity, or ancestry Exclusion Criteria: Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline) Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment Pregnant or nursing Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Individuals that do not have access to a working telephone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Education (HE) Group<br>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). | Drug: Nicotine Patch<br>* Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.<br>* Other names: NRT;Behavioral: Questionnaires<br>* 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.<br>* Other names: Surveys;Other: Carbon Monoxide (CO) Test<br>* Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.<br>Behavioral: Health Education and Handouts<br>* Participants receive general health education and handouts.<br>* Other names: Pamphlets;Behavioral: Counseling Sessions<br>* Participants attend 3 counseling sessions during the study.<br>|
| Experimental: Culturally Tailored Smoking Cessation (CTSC) Group<br>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). | Drug: Nicotine Patch<br>* Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.<br>* Other names: NRT;Behavioral: Questionnaires<br>* 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.<br>* Other names: Surveys;Other: Carbon Monoxide (CO) Test<br>* Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.<br>Behavioral: Culturally Tailored Reading Materials<br>* Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.<br>* Other names: Pamphlets;Behavioral: Counseling Sessions<br>* Participants attend 3 counseling sessions during the study.<br>|
| Experimental: Culturally Tailored Smoking + Adherence Enhancement (AE) Group<br>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). | Drug: Nicotine Patch<br>* Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.<br>* Other names: NRT;Behavioral: Questionnaires<br>* 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.<br>* Other names: Surveys;Other: Carbon Monoxide (CO) Test<br>* Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.<br>Behavioral: Culturally Tailored Reading Materials<br>* Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.<br>* Other names: Pamphlets;Behavioral: Counseling Sessions<br>* Participants attend 3 counseling sessions during the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Averaged across 3 study visits (Week 0 to Week 12) | 
| Patch Adherence: Percentage of Days With Patch | Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure. | This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment. | 
| 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. | Collected at the 3- and 6-month follow-up visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Prevention, Tobacco Use Cessation, Nicotine Patch, NRT, Questionnaires, Surveys, Carbon Monoxide Test, CO, Health Education, Handouts, Pamphlets, Counseling sessions