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

• 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
• 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
• 来源: https://reporter.nih.gov/project-details/9926433
• 关键词: Abstinence; Address; Adopted; Aftercare; Age-Years; Area; Arizona; Behavioral; Biochemical; Blood; Child; Clinical Trials; Cognitive Therapy; Cotinine; Counseling; Data; Effectiveness; Elements; Enrollment; Female; Funding; Future; Goals; Gonadal Steroid Hormones; Hour; Intervention; Luteal Phase; Measures; Mediator of activation protein; Menstrual cycle; Menstruation; Methods; Modeling; Morbidity - disease rate; Mothers; National Institute of Drug Abuse; Neurobiology; Nicotine; Outcome; Participant; Patient Self-Report; Phase; Premenopause; Prevalence; Protocols documentation; Public Health; Publishing; Questionnaires; Randomized; Randomized Controlled Trials; Recommendation; Research; Role; Science; Services; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Smoking Status; Social support; Source; Spottings; Standardization; Telephone; Telephone Interviews; Testing; Time; Tobacco; Weight; Withdrawal; Woman; base; behavior change; coping; cost; cost effective; cost efficient; craving; design; disorder risk; environmental tobacco smoke exposure; evidence base; experience; follow-up; high risk; improved; innovation; men; mortality; negative affect; nicotine replacement; nicotine use; novel; open label; primary outcome; programs; proliferative phase Menstrual cycle; protocol development; quitline; recruit; relapse risk; retention rate; satisfaction; smoking cessation; standard care; standard of care; success; theories; treatment program

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.

抽象的 尽管超过 75% 的女性吸烟者想要戒烟，但她们并没有像男性那样成功 有。这是特别值得关注的，因为绝经前女性吸烟者更有可能经历吸烟—— 相关发病率和死亡率高于男性吸烟者。此外，母亲是二手货的主要来源。 儿童接触烟雾。戒烟热线是一项影响广泛、具有成本效益的传播吸烟的计划 戒烟治疗；然而，很少有研究关注为女性量身定制戒烟热线计划。目标是 本研究旨在调查基于戒烟热线的创新干预措施的可行性和初步效果 绝经前女性吸烟者尝试戒烟的时间是她们的月经周期。新出现的证据表明 卵泡期（月经开始后两周）与尼古丁功效增强相关 与黄体期（月经前两周）相比，替代疗法（NRT）戒烟 发作）。因此，基于月经阶段的定时戒烟干预措施有可能提高戒烟率 在女性中，这是一个复吸风险较高的吸烟者群体。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的年龄。参与者将被随机分配到卵泡期组 （戒烟日期设定为月经来潮后六至八天）或标准护理控制（戒烟日期为月经来潮后三周） 登记，无论月经阶段如何，这是标准戒烟热线做法）。经期识别 将使用已发布的建议中的方法来确定。与现有的戒烟热线协议一致， 参与者将接受为期 4 周的 NRT（贴片）以及为期六周的基于电话的行为治疗 辅导。将在基线、第 0 周（戒烟日）、第 1 周、第 4 周（治疗结束）和第 1 周收集数据。 在第 3 个月进行随访，使用电话访谈、经过验证的问卷和干血点（以测量 性激素用于验证月经期，可替宁用于验证吸烟状况）。主要结果包括 确定这种基于月经周期的干预措施的可接受性和可行性（招募和保留 率、正确识别月经阶段的能力以及总体参与者研究满意度）。吸烟 戒烟结果（自我报告和/或生化验证）将在第 1 周、第 4 周（结束时）进行评估 治疗），以及第 3 个月的随访。最后，我们将从理论上探讨月经相位差异： 已知与戒烟相关的相关因素（例如社会支持、体重问题、迫切需要戒烟） 应对）。研究结果将指导方案开发并为更大规模的随机研究生成假设 对照试验。这项研究新颖而务实，整合了有关月经作用的新证据。 周期定时戒烟日期与最科学的戒烟热线戒烟计划。如果成功的话，这个模型可以 在州和国家戒烟热线计划中进行经济有效的复制。它可以解决独特的障碍 绝经前女性吸烟行为的改变，提高戒烟成功率并减少 与烟草相关的高发病率相关的疾病风险。

项目成果

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.

测试育龄妇女月经周期定时戒烟干预措施的可行性和可接受性（项目阶段）：试点随机对照试验的结果。

• 发表时间: 2022-02
• 影响因子: 4.4
• 作者: Allen, Alicia;Skobic, Iva;Bell, Melanie L;Medvescek, Kristina;Allen, Sharon;Collins, Bradley;Nair, Uma
• 通讯作者: Nair, Uma

Menstrual Phase Identification Questionnaire (MPIQ): Development and validation of a cross-sectional survey to identify follicular and luteal phases.

月经期识别问卷 (MPIQ)：开发和验证横断面调查，以确定卵泡期和黄体期。

• 发表时间: 2024-04
• 影响因子: 2.3
• 作者: Allen, Alicia M;Valenti, Michelle;Linde;Medvescek, Kristina;Farland, Leslie V
• 通讯作者: Farland, Leslie V