Endometriosis, Pelvic Pain
Conditions
Keywords
Group care, Integrative care, Pelvic floor physical therapy, Mindfulness, Patient-centered outcomes
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
Interventions
BEHAVIORALPEEPS
Participants will participate in the PEEPS program in addition to usual care.
BEHAVIORALEducation
Participants will receive an educational handout on endometriosis in addition to usual care.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a | Baseline, immediately after the intervention | Validated, 8-question survey that assesses pain interference in daily activities |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS pain intensity | Baseline, immediately after the intervention, 6- and 12-months after the intervention | Validated, 3-question survey that measures pain intensity on a 1-5 scale over the past 7 days |
| Endometriosis Health Profile-30 | Baseline, immediately after the intervention, 6- and 12-months after the intervention | Validated, 30-question endometriosis-related quality of life measure |
| PROMIS Physical Function SF10a | Baseline, immediately after the intervention, 6- and 12-months after the intervention | Validated, 10-questions survey that measures physical function such as walking, carrying groceries, and other activities of daily living |
| PROMIS pain interference SF 8a | Baseline, 6- and 12-months after the intervention | Validated, 8-question survey that assesses pain interference in daily activities |
| PROMIS Depression SF8b | Baseline, immediately after the intervention, 6- and 12-months after the intervention | Validated, 8-question survey that measures depression in past 7 days |
| Patient global impression of change | Immediately after the intervention, 6- and 12-months after the intervention | Validated, 1-question survey on impression of change over time |
| PROMIS Anxiety SF7a | Baseline, immediately after the intervention, 6- and 12-months after the intervention | Validated, 7-question survey that measures anxiety in past 7 days |
Countries
United States
Contacts
Primary ContactWhitney Ross, MD
Backup ContactJaime Strickland, MA
Outcome results
None listed