Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials
研究概览
简要总结
The purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.
详细描述
Study Aim 1: To transcreate the existing English-language 10 "Stop Smoking for Good" booklets and accompanying 9 supportive "My Story" pamphlets into a series of culturally relevant and acceptable materials for Spanish-speaking smokers who prefer to receive health information in Spanish. The adaptation of the intervention materials will be based upon the findings from a systematic formative evaluation employing a heterogeneous group of Hispanic/Latino smokers representing diverse subcultural groups.
Study Aim 2: To test the efficacy of the self-help intervention developed in Study I among Spanish-speaking smokers in a randomized controlled trial. Participants (500) will be randomized to receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention or usual care (UC) comprising an existing booklet from NCI. Investigators hypothesize SS-SP will produce higher abstinence rates than UC through 24 months.
Secondary Aim: Test moderator variables to improve targeting the intervention. Moderator analyses will be exploratory, without strong a priori hypotheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •All Except Study I; Phase I Focus Group: monolingual Spanish, or bilingual Spanish-English and prefer receiving educational health materials in Spanish.
- •Study I; Phase I Focus Group Only: Able to speak and read in English and Spanish.
- •≥ 1 year history of smoking
- •Smoking ≥ 5 cigarettes per week
- •Age ≥ 18 years
- •Not currently enrolled in a face-to-face smoking cessation program
排除标准
- 未提供
研究组 & 干预措施
Stop Smoking for Good Intervention in Spanish
Study II: Stop Smoking for Good Intervention in Spanish (SS-SP) will comprise a series of 10 booklets distributed over 18 months, plus additional monthly contacts via 9 supportive pamphlets developed in Study I. Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP) Assessments will occur at six-month intervals, through 24 months.
干预措施: Stop Smoking for Good Intervention in Spanish (SS-SP) (Behavioral)
Usual Care
Study II: Usual Care (UC) will comprise a single, Spanish-language, smoking cessation booklet developed by the National Cancer Institute (NCI). Behavioral: Usual care (UC) Assessments will occur at six-month intervals, through 24 months.
干预措施: Usual care (UC) (Behavioral)
结局指标
主要结局
Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials
时间窗: Up to 12 months
Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial.
Study II: Rate of Smoking Cessation
时间窗: Up to 24 months
Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm.
次要结局
未报告次要终点