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

NCT04620096 | Completed

• 2 other identifiers: STUDY00009993GODFRE20A0
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Menstrual Cycle

Outcome Measures

Primary Outcomes (2)

• Average change of Cystic Fibrosis-related pulmonary symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)

  Rating of Mild, Moderate, or Severe in the Clue smartphone app

  3 consecutive menstrual cycles (each cycle is 28 days) following enrollment

• Average change of Cystic Fibrosis-related sinus symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)

  Rating of Mild, Moderate, or Severe in the Clue smartphone app

  3 consecutive menstrual cycles (each cycle is 28 days) following enrollment

Secondary Outcomes (2)

• Average change of Cystic Fibrosis-related rheumatic symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)

  3 consecutive menstrual cycles (each cycle is 28 days) following enrollment

• Average change of Cystic Fibrosis-related gastrointestinal symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)

  3 consecutive menstrual cycles (each cycle is 28 days) following enrollment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Self-identify gender as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Regularly menstruating women with Cystic Fibrosis

You may qualify if:

• Females with CF, ages \> or = 18 and \< 46 years
• Able to read, speak, and understand English
• Have regular menstrual cycles between 21 and 35 days
• If using oral contraceptive pills, patch, or vaginal ring, must have a monthly withdrawal bleed every 21-35 days
• If on a genetic modulator, must be on steady dose for at least 3 months
• Willing to document daily symptoms (or no symptoms) every day for up to four consecutive months
• Has a functioning smartphone app with capability to load a "period tracking" app or, if no smartphone, is willing to complete a paper diary and mail to research team monthly
• Currently resides within the United States

You may not qualify if:

• Not regularly menstruating or no regular withdrawal bleed every 21-35 days (with or without hormonal contraception use)
• Planning pregnancy at the start of, or any time during, the 3-month observation period
• Planning to use a hormonal IUD, subdermal contraceptive implant (such as Nexplanon), or injectable contraceptive (such as Depo-Provera) at the start of, or any time during, the 3-month observation period
• Women on the transplant list or what have had a lung transplant

Sponsors & Collaborators

• University of Washington: lead
• University of Illinois at Chicago: collaborator
• University of California, San Diego: collaborator
• Mount Sinai Hospital, New York: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Emily Godfrey, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Sandy Sufian, PhD, MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Family Medicine

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 6, 2020
• Study Start: June 1, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)