Clinical trial NCT06549985: Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
Official title: Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Keywords: Group care
Integrative care
Pelvic floor physical therapy
Mindfulness
Patient-centered outcomes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
timeFrame: Baseline, immediately after the intervention
Secondary outcomes:
Other outcomes:
measure: PROMIS pain interference SF 8a
timeFrame: Baseline, 6- and 12-months after the intervention
measure: PROMIS pain intensity
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: Endometriosis Health Profile-30
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: PROMIS Physical Function SF10a
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: PROMIS Anxiety SF7a
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: PROMIS Depression SF8b
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: Female Sexual Function Index
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: Pain Catastrophizing Scale
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
measure: Patient global impression of change
timeFrame: Immediately after the intervention, 6- and 12-months after the intervention
measure: Personal goals
timeFrame: Baseline, immediately after the intervention, 6- and 12-months after the intervention
Locations:
city: Saint Louis
country: United States
facility: WashU Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Whitney Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: