Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain (NCT06549985) | Clinical Trial Compass
RecruitingNot Applicable
Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
United States60 participantsStarted 2025-03-17
Plain-language summary
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
Who can participate
Age range
18 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-48 years
* Operative confirmation of endometriosis
* Chronic pelvic pain (pain perceived to originate from the pelvis, not exclusively during menses, lasting ≥6 months)
* No plan to have surgery before or during the PEEPS cohort
* Able to attend at least six of the eight 2-hour weekly sessions on the Washington University campus
* Comfort reading and speaking English as groups and materials are in English
Exclusion Criteria:
* Currently pregnant
* Severe physical impairment (limiting yoga participation)
* History of hip or spine surgery given increased risk of harm and need for extensive activity modification
* Current or history of psychiatric disorder with psychosis in order to minimize risk of adverse mental health effects to participants
* Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
* History of surgical removal of bilateral ovaries
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
Timeframe: Baseline, immediately after the intervention