Endometriosis Group Care

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question[s] it aims to answer are: Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes? What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.

Detailed Description
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This is an 8 week interdisciplinary, integrative group care program conducted through the Department of Obstetrics and Gynecology (OB/GYN) at Washington University in St. Louis (WUSTL). The program, called PEEPS, incorporates mindfulness, physical therapy, yoga, physical activity, nutrition, and education. Additionally, PEEPS will provide peer support and demonstrate investment of individual clinicians and the healthcare system. The program focuses on equipping participants with pain management and coping skills so they have an expanded toolkit to manage their pain after completing the program.

Official Title
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A Novel Approach to Endometriosis Treatment: Piloting an Interdisciplinary Group Care Model

Conditions
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Endometriosis, Pelvic Pain

Intervention / Treatment
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* Other: Peer Empowered Endometriosis Pain Support (PEEPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-48 years Operative confirmation of endometriosis Chronic pelvic pain (defined as pain perceived to originate from the pelvis, lasting ≥6 months) No plan to have surgery in next 12 weeks Be able to attend eight 2-hour weekly sessions on the Washington University campus Exclusion Criteria: Non-English speaking Currently pregnant Severe physical impairment History of hip or spine surgery Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period Current or history of psychiatric disorder with psychosis Vulvadynia or vaginismus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometriosis group care<br>Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions. | Other: Peer Empowered Endometriosis Pain Support (PEEPS)<br>* The sessions will provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Patients will additionally receive peer and clinician support to decrease the social isolation experienced by people with endometriosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference | Change in reported pain after PEEPS program completion by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | Change in reported physical function, measured by the PROMIS Physical Function Scale | 8 weeks | 
| Sexual Function | Change in reported sexual function, measured by the Female Sexual Function Index | 8 weeks | 
| Endometriosis-specific quality of life | Endometriosis-specific quality of life, measured by Endometriosis Health Profile-30 | 8 weeks | 
| Anxiety | Change in reported anxiety, measured by the PROMIS Anxiety Scale | 8 weeks | 
| Depression | Change in reported depression, measured by the PROMIS Depression Scale | 8 weeks | 
| Pain Catastrophizing | Change in reported catastrophizing, measured by the Pain Catastrophizing Scale | 8 weeks | 
| Overall symptom improvement | Change in overall symptoms, measured by the Patient Global Impression of Change Scale | 8 weeks | 
| Modified every day discrimination scale | To assess experiences of healthcare discrimination | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group care, Integrative care, Pelvic floor physical therapy, Yoga, Mindfulness, Patient-centered outcomes