RECRUITING

Health Outcomes of Parents With Cystic Fibrosis-Aim 2

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.

Official Title

Health Outcomes of Parents With Cystic Fibrosis-Aim 2

Quick Facts

Study Start:2024-05-29
Study Completion:2031-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06296394

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with cystic fibrosis via sweat test or genotype analysis
  2. * Became a first-time parent (including foster parent, step parent, adoptive parent, or legal guardian) to a child under 5 years of age within the last 90 days
  1. * Undergone a lung transplant
  2. * Does not speak/read English or Spanish

Contacts and Locations

Study Contact

Olivia M Stransky, MPH
CONTACT
412-648-4701
stranskyom@upmc.edu

Principal Investigator

Traci M Kazmerski, MD
PRINCIPAL_INVESTIGATOR
Faculty

Study Locations (Sites)

University of Alabama-Birmingham
Birmingham, Alabama, 35294
United States
National Jewish Health
Denver, Colorado, 80206
United States
Northwestern University
Evanston, Illinois, 60208
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Johns Hopkins University
Baltimore, Maryland, 21218
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Children's Hospital/Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
University of Texas-Southwestern
Dallas, Texas, 75390
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Traci M Kazmerski, MD, PRINCIPAL_INVESTIGATOR, Faculty

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 Registration Dates

Study Start Date2024-05-29
Study Completion Date2031-02-01

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2031-02-01

Terms related to this study

Keywords Provided by Researchers

  • cystic fibrosis
  • parenthood
  • highly effective modulator therapy

Additional Relevant MeSH Terms

  • Cystic Fibrosis
  • Parenthood Status