Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorWashington University School of Medicine
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PEEPS
BehavioralParticipants will participate in the PEEPS program in addition to usual care.
Education
BehavioralParticipants will receive an educational handout on endometriosis in addition to usual care.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Peer Empowered Endometriosis Pain Support (PEEPS)Experimental treatment 1 intervention
Group B: EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
Validated, 8-question survey that assesses pain interference in daily activities
Time frame
Baseline, immediately after the interventionOther outcomes
1
PROMIS pain interference SF 8a
Validated, 8-question survey that assesses pain interference in daily activities
Time frame
Baseline, 6- and 12-months after the intervention2
PROMIS pain intensity
Validated, 3-question survey that measures pain intensity on a 1-5 scale over the past 7 days
Time frame
Baseline, immediately after the intervention, 6- and 12-months after the intervention3
Endometriosis Health Profile-30
Validated, 30-question endometriosis-related quality of life measure
Time frame
Baseline, immediately after the intervention, 6- and 12-months after the intervention4
PROMIS Physical Function SF10a
Validated, 10-questions survey that measures physical function such as walking, carrying groceries, and other activities of daily living
Time frame
Baseline, immediately after the intervention, 6- and 12-months after the interventionSponsors and contacts
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Source ClinicalTrials.gov