Menstrual Phase and Smoking Cessation at a State Quitline
Condition: Menstrual Cycle
Study type: Interventional

Summary: 
      Quitlines are efficient and cost-effective treatments for smoking cessation, yet little
      research has explored how to personalize and optimize quitline services for women. The goal
      of this project is to explore the feasibility and preliminary efficacy of a quitline
      intervention that considers the menstrual cycle as compared to standard care for cessation.
      If funded, the results of this study will directly inform future research on quitline smoking
      cessation interventions for premenopausal women, including a full scale clinical trial.
    

Detailed description: 
      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 how the quit interventions can be informed by the menstrual cycle to improve
      cessation outcomes in women. This study will enroll 116 women between 18-40 years of age from
      the Arizona Smokers' Helpline. 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.
    

Intervention name(s): Menstrual Cycle Timing; Menstrual Cycle Timing; NRT Patch; Cessation Counseling
Intervention type(s): Other; Other; Drug; Behavioral
Intervention description(s): Quit date is set to menstrual phase.; Menstrual cycle timing of quit date is monitored; NRT patch is provided; Cessation counseling is provided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment