RECRUITING

Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

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 clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care program, decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48. The main question we aim to answer is: Is PEEPS more effective than Education in decreasing pain interference? Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain, physical function, and quality of life. Participants will: * Complete baseline quality of life surveys * Participate in an 8-session group care program * Provide feedback on each session and the program globally * Complete follow up quality of life surveys at PEEPS completion, 6- and 12-months post-completion. * A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS

Official Title

Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial

Quick Facts

Study Start:2025-03
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06549985

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 to 48 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-48 years
  2. * Operative confirmation of endometriosis
  3. * Chronic pelvic pain (pain perceived to originate from the pelvis, not exclusively during menses, lasting ≥6 months)
  4. * No plan to have surgery before or during the PEEPS cohort
  5. * Able to attend at least six of the eight 2-hour weekly sessions on the Washington University campus
  6. * Comfort reading and speaking English as groups and materials are in English
  1. * Currently pregnant
  2. * Severe physical impairment (limiting yoga participation)
  3. * History of hip or spine surgery given increased risk of harm and need for extensive activity modification
  4. * Current or history of psychiatric disorder with psychosis in order to minimize risk of adverse mental health effects to participants
  5. * Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
  6. * History of surgical removal of bilateral ovaries

Contacts and Locations

Study Contact

Whitney Ross, MD
CONTACT
314-747-5470
ross.w@email.wustl.edu
Jaime Strickland, MA
CONTACT
314-747-1390
jaime.strickland@wustl.edu

Principal Investigator

Whitney Ross, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

WashU Medicine
Saint Louis, Missouri, 63108
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Whitney Ross, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2025-03
Study Completion Date2028-09

Study Record Updates

Study Start Date2025-03
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • Group care
  • Integrative care
  • Pelvic floor physical therapy
  • Mindfulness
  • Patient-centered outcomes

Additional Relevant MeSH Terms

  • Endometriosis
  • Pelvic Pain