- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620096
MENstrual Symptom Tracking to Understand and Assess (Women) Living With Cystic Fibrosis (MENSTRUAL)
May 18, 2023 updated by: Emily Godfrey, University of Washington
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
74
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Regularly menstruating women with Cystic Fibrosis
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
|
Rating of Mild, Moderate, or Severe in the Clue smartphone app
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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)
Time Frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
|
Rating of Mild, Moderate, or Severe in the Clue smartphone app
|
3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
|
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 gastrointestinal symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Time Frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
|
Rating of Mild, Moderate, or Severe in the Clue smartphone app
|
3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandy Sufian, PhD, MPH, University of Illinois at Chicago
- Principal Investigator: Emily Godfrey, MD, MPH, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
April 22, 2022
Study Completion (Actual)
April 22, 2022
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
November 2, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 18, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009993
- GODFRE20A0 (Other Grant/Funding Number: Cystic Fibrosis Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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