Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
NCT Number: NCT06549985
Acronym: PEEPS RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis|Pelvic Pain
Interventions: BEHAVIORAL: PEEPS|BEHAVIORAL: Education
Sponsor: Washington University School of Medicine
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03
Completion Date: 2028-09

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

Primary Outcome Measures: Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a, Validated, 8-question survey that assesses pain interference in daily activities, Baseline, immediately after the intervention
Other Outcome Measures: PROMIS pain interference SF 8a, Validated, 8-question survey that assesses pain interference in daily activities, Baseline, 6- and 12-months after the intervention|PROMIS pain intensity, Validated, 3-question survey that measures pain intensity on a 1-5 scale over the past 7 days, Baseline, immediately after the intervention, 6- and 12-months after the intervention|Endometriosis Health Profile-30, Validated, 30-question endometriosis-related quality of life measure, Baseline, immediately after the intervention, 6- and 12-months after the intervention|PROMIS Physical Function SF10a, Validated, 10-questions survey that measures physical function such as walking, carrying groceries, and other activities of daily living, Baseline, immediately after the intervention, 6- and 12-months after the intervention|PROMIS Anxiety SF7a, Validated, 7-question survey that measures anxiety in past 7 days, Baseline, immediately after the intervention, 6- and 12-months after the intervention|PROMIS Depression SF8b, Validated, 8-question survey that measures depression in past 7 days, Baseline, immediately after the intervention, 6- and 12-months after the intervention|Female Sexual Function Index, Validated, 19-question survey on female sexual function, Baseline, immediately after the intervention, 6- and 12-months after the intervention|Pain Catastrophizing Scale, Validated, 13-question survey that measures pain catastrophizing behaviors, Baseline, immediately after the intervention, 6- and 12-months after the intervention|Patient global impression of change, Validated, 1-question survey on impression of change over time, Immediately after the intervention, 6- and 12-months after the intervention|Personal goals, At baseline, we will ask participants to identify three personal goals related to quality of life that they hope to achieve, such as "Be able to go on a hike without pain limiting my activity", Baseline, immediately after the intervention, 6- and 12-months after the intervention