RECRUITING

Reducing Disparities in Urinary Control Symptoms for Minority Women

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 study is designed to address the disparity in available conservative/behavioral treatments for UI/LUTS. The program was developed by experts from urogynecology, psychology, and physical therapy then modified based on focus group feedback from racially minoritized women. The study team created a patient-centered, culturally adapted, self-directed, 8-week, home-based module for women with LUTS/UI. The SUPPORT program combines multiple evidence-based conservative treatments for LUTS/UI including cognitive behavioral therapy, behavioral modifications, and home physical therapy exercise. Progression through the home-based program is supported by research staff. This prospective interventional study aims to evaluate the feasibility and acceptability of the SUPPORT program and its impact on patient-centered treatment outcomes, while enabling comparisons across race and ethnicity. This approach will provide a comprehensive understanding of how to effectively deliver self-management strategies for pelvic floor disorders. At the start of the 8 week SUPPORT course participants will also be given access to a custom programmed GPT trained on the SUPPORT workbook and given instructions on empathetic communication techniques and assisting patients in performing the SUPPORT exercises as outlined in the program. At the end of 8 weeks patients will fill out a survey assessing the frequency of use and interactions with the LLM.

Official Title

Reducing Disparities in Urinary Control Symptoms for Minority Women

Quick Facts

Study Start:2024-10-28
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06798311

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Able to converse in English
  3. * A response of at least "somewhat bothered" by urinary incontinence, urinary frequency or urgency on the UDI
  4. * Willing to engage in conservative treatment of their UI/LUTS for 16 weeks
  1. * Anterior or posterior pelvic organ prolapse beyond the hymen or apical prolapse to the hymen
  2. * Currently taking medications for their UI/LUTS or history of surgical intervention for UI
  3. * Patients with abnormal PVR and positive urine culture at time of study entry
  4. * History of recurrent UTIs
  5. * History of mobility or neurologic disorders that would prevent ability to complete at home physical therapy
  6. * Planning to start PT within the next 16 weeks

Contacts and Locations

Study Contact

Jinxuan (Rowena) Shi, MA
CONTACT
773-795-2731
jinxuan.shi@bsd.uchicago.edu
Tara Samsel, BS
CONTACT
773-795-2729
tara.samsel@bsd.uchicago.edu

Principal Investigator

Kimberly Kenton, MD
PRINCIPAL_INVESTIGATOR
University of Chicago
James Griffith, PhD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States
The University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Kimberly Kenton, MD, PRINCIPAL_INVESTIGATOR, University of Chicago
  • James Griffith, PhD, PRINCIPAL_INVESTIGATOR, University of Chicago

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 Date2024-10-28
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-10-28
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • cognitive behavioral therapy
  • self-directed
  • physical therapy
  • behavioral modifications
  • pelvic floor
  • home-based
  • health disparities

Additional Relevant MeSH Terms

  • Urinary Incontinence (UI)
  • Lower Urinary Tract Symptoms (LUTS)
  • Pelvic Floor Disorder