Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-language RCT

扩大经验证的戒烟干预措施的范围：西班牙语随机对照试验

• 批准号: 9111478
• 负责人: THOMAS H BRANDON
• 金额: $ 56.93万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-25 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9111478
• 关键词: Abstinence; Acculturation; Address; Adult; Affect; Age; Awareness; Behavioral; Clinical Practice Guideline; Clinical Trials; Counseling; Country; Cuban; Dominican; Education; Effect Modifiers (Epidemiology); Evidence based intervention; Face; Funding; Gender; Goals; Health Personnel; High Prevalence; Hispanics; Income; Individual; Intervention; Intervention Trial; Language; Latino; Letters; Low income; Motivation; National Cancer Institute; Nicotine Dependence; Outcome; Outcome Assessment; Pamphlets; Participant; Pharmacotherapy; Prevalence; Preventable cancer cause; Public Health; Puerto Rican; Randomized; Randomized Clinical Trials; Recruitment Activity; Relapse; Research; Self Efficacy; Smoker; Smoking; Smoking Cessation Intervention; Social support; Subgroup; Testing; Time; Tobacco Dependence; Tobacco smoking; Tobacco use; Treatment Efficacy; Underserved Population; United States; Woman; Work; Writing; arm; base; cost; cost effective; cost effectiveness; disorder later incidence prevention; efficacy testing; ethnic health disparity; ethnic minority population; evidence base; follow-up; men; mortality; nicotine replacement; novel; prevent; psychologic; public health relevance; racial minority; self help; smoking cessation; smoking intervention; smoking prevalence; smoking relapse; theories; tobacco abstinence; trait; treatment as usual

 DESCRIPTION (provided by applicant): Tobacco smoking is the leading preventable cause of cancer mortality. Pharmacotherapy and behavioral counseling have demonstrated independent and additive effects toward aiding smoking cessation; however, counseling is rarely chosen by smokers. In contrast, minimal self-help interventions, such as smoking cessation pamphlets or booklets have much wider potential reach, yet their efficacy has been largely disappointing, with incremental abstinence rates averaging only 1 percent. Given the high dissemination potential, any significant improvement in the efficacy of self-help would have high public health impact with respect to smoking and smoking related illness and mortality. In contrast to traditional self-help, a notable exception to the historically poor efficacy of self-help has been extended self-help that provides evidence-based content over a prolonged period of time. A recently completed trial of such an intervention, comprising 18 months of contact with a written social support component, revealed high efficacy throughout the 24-month follow-up period, as well as high cost- effectiveness. Wide-scale implementation and public health impact would be enhanced by the availability of a Spanish-language version to reach the largest and fastest growing ethnic minority population of smokers. The current smoking prevalence among Hispanic/Latino adults varies by cultural subgroup, with prevalence above 30 percent, for example, among those of Puerto Rican and Cuban descent. Greater smoking prevalence is also associated with lower income and education, and greater US acculturation. Prior research has demonstrated that Hispanic/Latino smokers face unique challenges such as lower awareness and acceptability of pharmacotherapies and less assistance with smoking cessation from their health providers. The goal of this study is to address this gap in cessation by conducting a randomized clinical trial to test the efficacy of a culturally appropriate Spanish-language version of the existing validated self-help intervention. The efficacy of this intervention will be tested against two control conditions. The first, Usual Care, will consist of a traditional self-help intervention in Spanish. The second, Contact Control, will match the novel intervention on time and contact. These two control conditions address external and internal validity, respectively. It is hypothesized that, compared to both the Usual Care and the Contact Control conditions, the intervention will produce higher abstinence rates throughout 24 months of outcome assessment. Potential moderator variables will be evaluated to guide further refinement and targeting of the intervention. This would be the first study to test a Spanish-language adaptation of a validated self-help smoking cessation intervention in a nation-wide RCT. If efficacy is demonstrated in this study, a low-cost, easily disseminated, evidence-based intervention would be available, with the potential to reduce ethnic health disparities associated with tobacco smoking.

 描述(申请人提供)：吸烟是导致癌症死亡的首要可预防原因。药物治疗和行为咨询在帮助戒烟方面显示出独立和相加的作用；然而，吸烟者很少选择咨询。相比之下，最低限度的自助干预措施，如戒烟小册子或小册子，潜在的影响范围要广得多，但它们的效果在很大程度上令人失望，递增戒烟率平均只有1%。鉴于自助的传播潜力很大，自助功效的任何重大改进都将对吸烟和与吸烟有关的疾病和死亡率产生很大的公共健康影响。与传统的自助不同，自助的一个显著例外是延伸自助，它在很长一段时间内提供基于证据的内容。最近完成的这种干预试验，包括与书面社会支持部分接触18个月，显示出在24个月的随访期内的高疗效和高成本效益。通过提供西班牙语版本，使吸烟者这一人数最多、增长最快的少数族裔人口能够接触到吸烟者，将加强大规模的执行和对公共卫生的影响。西班牙裔/拉丁裔成年人目前的吸烟率因文化亚群而异，例如，波多黎各人和古巴人后裔的吸烟率超过30%。更高的吸烟率也与较低的收入和教育水平以及更多的美国文化适应有关。先前的研究表明，拉美裔/拉丁裔吸烟者面临着独特的挑战，例如对药物疗法的认识和接受度较低，以及他们的健康提供者对戒烟的帮助较少。这项研究的目标是通过进行一项随机临床试验来测试文化上合适的西班牙语版本的疗效，从而解决戒烟方面的这一差距。 现有有效的自助干预措施。这一干预措施的有效性将在两种控制条件下进行测试。第一个是常规护理，将由西班牙语的传统自助干预组成。第二种是接触控制，它将在时间和接触上与新颖的干预相匹配。这两个控制条件分别涉及外部有效性和内部有效性。据推测，与常规护理和接触控制条件相比，在24个月的结果评估中，干预将产生更高的禁酒率。将对潜在的主持人变量进行评估，以指导干预措施的进一步细化和定向。这将是第一项在全国范围内的随机对照试验中测试经过验证的自助戒烟干预的西班牙语适应性的研究。如果这项研究证明了有效性，就有可能提供一种低成本、易于传播的循证干预措施，有可能减少与吸烟有关的种族健康差异。