Menstrual Phase and Smoking Cessation at a State Quitline (Project Phase)

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

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Cycle
• Intervention / Treatment: Other: Menstrual Cycle Timing; Other: Menstrual Cycle Timing; Drug: NRT Patch; Behavioral: Cessation Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Regular smoking
• Regular, natural menstrual cycles
• Interested in quitting

Exclusion Criteria:

• Pregnancy
• Breastfeeding
• Contraindications to NRT patch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menstrual Cycle Timing	Other: Menstrual Cycle Timing; Quit date is set to menstrual phase.; Other: Menstrual Cycle Timing; Menstrual cycle timing of quit date is monitored; Drug: NRT Patch; NRT patch is provided; Behavioral: Cessation Counseling; Cessation counseling is provided
Active Comparator: Menstrual Cycle Monitoring	Other: Menstrual Cycle Timing; Quit date is set to menstrual phase.; Other: Menstrual Cycle Timing; Menstrual cycle timing of quit date is monitored; Drug: NRT Patch; NRT patch is provided; Behavioral: Cessation Counseling; Cessation counseling is provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	Average number of participants enrolled per month	Week -3
Treatment Retention Feasibility	Total number of participants who complete to end of treatment	Week 4
Follow-up Retention Feasibility	Total number of participants who complete follow-up	Month 3
Feasibility Menstrual Phase Identification	Total proportion of active participants who have a progesterone level of <2 ng/ml on quit date	Week 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	Biochemically confirmed abstinence	Week 4, Month 3
Smoking Cessation	Self-reported abstinence	24 hours, Week 1

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1805561891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No