Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Abstinent Participants
研究概览
简要总结
The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Nicotine Patch (Drug)
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).
干预措施: Questionnaires (Behavioral)
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).
干预措施: Carbon Monoxide (CO) Test (Other)
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).
干预措施: Health Education and Handouts (Behavioral)
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).
干预措施: Counseling Sessions (Behavioral)
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).
干预措施: Nicotine Patch (Drug)
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).
干预措施: Questionnaires (Behavioral)
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).
干预措施: Carbon Monoxide (CO) Test (Other)
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).
干预措施: Culturally Tailored Reading Materials (Behavioral)
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).
干预措施: Counseling Sessions (Behavioral)
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).
干预措施: Nicotine Patch (Drug)
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).
干预措施: Questionnaires (Behavioral)
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).
干预措施: Carbon Monoxide (CO) Test (Other)
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).
干预措施: Culturally Tailored Reading Materials (Behavioral)
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).
干预措施: Counseling Sessions (Behavioral)
结局指标
主要结局
Number of Abstinent Participants
时间窗: Collected at the 3- and 6-month follow-up visits
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.
Intervention Feasibility & Acceptability
时间窗: Averaged 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 Patch
时间窗: This 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.
次要结局
未报告次要终点