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Testing the Feasibility of a Novel Smoking Cessation Intervention by Timing Quit Dates to Menstrual Phase in a Quitline Setting

通过在戒烟热线设置中将戒烟日期安排在月经期来测试新型戒烟干预措施的可行性

基本信息

批准号：
9926433
负责人：
Alicia M Allen
金额：
$ 0.81万
依托单位：
UNIVERSITY OF ARIZONA
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-06-15 至 2021-05-31
项目状态：
已结题

项目摘要

ABSTRACT Although more than 75% of women who smoke want to quit, they do not have the same success that men have. This is of particular concern as premenopausal women smokers are more likely to experience smoking- related morbidity and mortality than men smokers. Further, mothers are the primary source of secondhand smoke exposure in children. Quitlines are broad reaching, cost-effective programs that disseminate smoking cessation treatment; however, little research has focused on tailoring quitline programs for women. The goal of this study is to investigate the feasibility and preliminary efficacy of an innovative quitline-based intervention that times premenopausal female smokers' quit attempts to their menstrual cycle. Emerging evidence indicates the follicular phase (two weeks post onset of menses) is associated with increased efficacy of nicotine replacement therapy (NRT) for smoking cessation as compared to the luteal phase (two weeks prior to menses onset). Thus, timing cessation interventions based on menstrual phase has potential to improve quit rates among women, a group of smokers at high-risk for relapse. This study will enroll 116 women between 18-40 years of age from the Arizona Smokers' Helpline. Participants will be randomized to the follicular phase group (quit date set six to eight days post onset of menses) or standard care control (quit date three weeks after enrollment, regardless of menstrual phase, which is standard quitline practice). Menstrual phase identification will be determined using methods from published recommendations. Consistent with existing quitline protocols, participants will receive 4-weeks of NRT (patch) concurrent with six-weeks of telephone-based behavioral coaching. Data will be collected at Baseline, Week 0 (quit day), Week 1, Week 4 (end of treatment), and a follow-up at Month 3 using telephone interviews, validated questionnaires, and dried blood spots (to measure sex hormones to verify menstrual phase and cotinine to verify smoking status). Primary outcomes include determining acceptability and feasibility of this menstrual-cycle based intervention (recruitment and retention rate, the ability to correctly identify the menstrual phase, and overall participant study satisfaction). Smoking cessation outcomes (self-report and/or biochemically verified) will be assessed at Week 1, Week 4 (end of treatment), and at Month 3 follow-up. Finally, we will explore menstrual phase differences in theoretically- relevant factors known to be associated with smoking cessation (e.g., social support, weight concerns, urge coping). Study results will guide protocol development and generate hypotheses for larger-scaled randomized controlled trials. This study is novel and pragmatic, integrating emerging evidence for the role of menstrual- cycle timed quit dates with state-of-the-science quitline cessation programs. If successful, this model can be cost-effectively replicated within state and national quitline programs. It can address the unique barriers to smoking behavior change among premenopausal women, increase successful quit outcomes and reduce disease risk associated with high tobacco-related morbidity rates.

摘要尽管超过75%的吸烟女性想要戒烟，但她们并没有男性那样成功有.这一点尤其令人关注，因为绝经前的吸烟妇女更有可能吸烟- 相关发病率和死亡率高于男性吸烟者。此外，母亲是第二次怀孕的主要来源。儿童吸烟。戒烟热线是一种广泛的、具有成本效益的传播吸烟的计划戒烟治疗;然而，很少有研究集中在为妇女量身定制戒烟方案。的目标本研究旨在探讨一种创新的基于戒烟线的干预方法的可行性和初步疗效绝经前女性吸烟者的戒烟尝试次数与月经周期的关系。新出现的证据表明卵泡期（月经开始后两周）与尼古丁的功效增加有关与黄体期（月经前两周）相比，戒烟的替代疗法（NRT 发病）。因此，基于月经期的定时戒烟干预有可能提高戒烟率在妇女中，吸烟者是复吸的高风险群体。这项研究将招募116名18-40岁的女性亚利桑那州吸烟者帮助热线参与者将被随机分配到卵泡期组 (quit日期设定在月经开始后6 - 8天）或标准护理对照（停止日期在月经开始后3周登记，无论月经期，这是标准的退出实践）。月经期鉴定将使用已公布的建议中的方法确定。与现有的退出协议一致，参与者将接受为期4周的NRT（贴片），同时接受为期6周的基于电话的行为教练将在基线、第0周（退出日）、第1周、第4周（治疗结束）和第10周（治疗结束日）收集数据。在第3个月使用电话访谈、经验证的问卷和干血斑进行随访（以测量性激素来验证月经期和可替宁来验证吸烟状态）。主要成果包括确定这种基于周期的干预措施（招募和保留）的可接受性和可行性率，正确识别月经期的能力，以及总体参与者研究满意度）。吸烟将在第1周、第4周（治疗结束时）和第5周（治疗结束时）评估戒烟结局（自我报告和/或生化验证）。治疗）和第3个月随访时。最后，我们将从理论上探讨月经周期的差异- 已知与戒烟相关的相关因素（例如，社会支持，重视关注，敦促应对）。研究结果将指导方案制定，并为更大规模的随机化研究提供假设。对照试验。这项研究是新颖和务实的，整合了月经的作用的新证据，循环定时戒烟日期与国家的科学戒烟热线戒烟计划。如果成功的话，这种模式可以在州和国家戒烟计划中以具有成本效益的方式复制。它可以解决独特的障碍，绝经前妇女吸烟行为的改变，增加成功戒烟的结果，与烟草相关的高发病率相关的疾病风险。