NCT04620096

MENstrual Symptom Tracking to Understand and Assess (Women) Living With Cystic Fibrosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Cystic fibrosis (CF) affects men and women equally, but after the onset of puberty, women with CF have a lower life expectancy than men with CF. Despite these known differences, the link between CF symptom trends and the menstrual cycle remains critically understudied. To address this gap, this study will investigate changes in CF-specific symptoms among women with CF to evaluate whether and how they correlate with their menstrual cycle. Specifically, the investigators hope to examine whether CF-related symptoms change throughout the menstrual cycle, what the impact of those symptoms is on quality of life, and how feasible it is to use a period tracking app to track CF-related symptoms throughout the menstrual cycle. Investigators are asking women ages 18-45 with CF, who have regular menstrual cycles, to participate. Study procedures, including online surveys, period tracking, and interview, will take approximately 3 months.

Detailed description

To better understand the connection between cyclically driven hormone fluctuations and CF-related symptoms, the investigators propose an explanatory, sequential mixed methods study in which 80 menstruating women with CF will be asked to track their daily CF-related symptoms for three consecutive cycles. From this cohort, the investigators will ask up to 30 women with CF to participate in one semi-structured interview to gather information about the impact of cyclical CF symptoms upon women's daily lives and any strategies they use to manage them. This study uses innovative technology to track CF-specific symptoms with a smartphone app. The investigators' hypothesis is that subjective changes in clinical CF symptoms, including pulmonary and sinus (primary outcome), rheumatic, and gastrointestinal (secondary outcomes), will map onto the phases of the menstrual cycle and will be cyclical in nature; women will report alternative ways in which they manage their cyclical CF symptoms; and the period tracker app will be easy for women to use.

Conditions

• Cystic Fibrosis

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2020-11-06
• Last updated: 2023-05-22

Locations

1 site across 1 country: United States