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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometriosis group care | Experimental | Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Empowered Endometriosis Pain Support (PEEPS) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Interference SF 8a | Change in pain interference at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more pain). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Physical Function SF10a | Change in physical function at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more/better physical function). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27159755 | Background | Mowers EL, Lim CS, Skinner B, Mahnert N, Kamdar N, Morgan DM, As-Sanie S. Prevalence of Endometriosis During Abdominal or Laparoscopic Hysterectomy for Chronic Pelvic Pain. Obstet Gynecol. 2016 Jun;127(6):1045-1053. doi: 10.1097/AOG.0000000000001422. | |
| 12699255 | Background | Missmer SA, Cramer DW. The epidemiology of endometriosis. Obstet Gynecol Clin North Am. 2003 Mar;30(1):1-19, vii. doi: 10.1016/s0889-8545(02)00050-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endometriosis Group Care | Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions. Peer Empowered Endometriosis Pain Support (PEEPS): 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
35 completed baseline surveys, 33 attended at least 1 session, 1 participant withdrew after attending 1 session
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| ID | Title | Description |
|---|---|---|
| BG000 | Endometriosis Group Care | Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions. Peer Empowered Endometriosis Pain Support (PEEPS): 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PROMIS Pain Interference SF 8a | Change in pain interference at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more pain). | Posted | Least Squares Mean | Standard Error | t-score | 8 weeks |
|
From start of study through 6 months post-intervention completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endometriosis Group Care | Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions. Peer Empowered Endometriosis Pain Support (PEEPS): 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Whitney Ross | WashU Medicine | 314-747-5470 | ross.w@email.wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2022 | Dec 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2025 | Dec 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| 8 weeks |
| Female Sexual Function Index | Change in reported sexual function, measured by the Female Sexual Function Index. 19-question validated survey administered to participants who endorsed being sexually active. Composite score is reported. The Scale Score Range is from 2.0 to 36.0 with higher score indicating better sexual function. | 8 weeks |
| Endometriosis Health Profile-30 | Change in endometriosis-specific quality of life (measured by Endometriosis Health Profile-30) at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. This is a 30-question survey with 5 sub-domains. Composite score is reported. The score range is from 0 (best possible health status) to 100 (worst possible health status measured by the questionnaire). Lower scores mean better health. | 8 weeks |
| PROMIS Anxiety SF7a | Change in anxiety at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more anxiety). | 8 weeks |
| PROMIS Depression SF8b | Change in depression at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more depression). Lower score indicates symptom improvement. | 8 weeks |
| Patient Global Impression of Change (PGIC) | Percentage of Participants Reporting Improved Symptoms at PEEPS completetion measured by the Patient Global Impression of Change Scale. A score of 6 or greater indicates clinically significant improvement in symptoms. | 8 weeks |
| Modified Every Day Discrimination Scale | To assess experiences of healthcare discrimination, this Modified Every Day Discrimination Scale was administered at baseline. It is a validated survey that assesses experience of discrimination in 10 potential domains. Percentage of participants reporting experiencing discrimination "at least a few times per year" or more frequently is reported. | Baseline |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | PROMIS Physical Function SF10a | Change in physical function at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more/better physical function). | Posted | Least Squares Mean | Standard Error | t-score | 8 weeks |
|
|
|
| Secondary | Female Sexual Function Index | Change in reported sexual function, measured by the Female Sexual Function Index. 19-question validated survey administered to participants who endorsed being sexually active. Composite score is reported. The Scale Score Range is from 2.0 to 36.0 with higher score indicating better sexual function. | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
|
|
|
| Secondary | Endometriosis Health Profile-30 | Change in endometriosis-specific quality of life (measured by Endometriosis Health Profile-30) at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. This is a 30-question survey with 5 sub-domains. Composite score is reported. The score range is from 0 (best possible health status) to 100 (worst possible health status measured by the questionnaire). Lower scores mean better health. | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
|
|
|
| Secondary | PROMIS Anxiety SF7a | Change in anxiety at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more anxiety). | Posted | Least Squares Mean | Standard Error | t-score | 8 weeks |
|
|
|
| Secondary | PROMIS Depression SF8b | Change in depression at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more depression). Lower score indicates symptom improvement. | Posted | Least Squares Mean | Standard Error | T-score | 8 weeks |
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| Secondary | Patient Global Impression of Change (PGIC) | Percentage of Participants Reporting Improved Symptoms at PEEPS completetion measured by the Patient Global Impression of Change Scale. A score of 6 or greater indicates clinically significant improvement in symptoms. | 37.5% of PEEPS participants endorsed that their activity limitations, symptoms, emotions, and overall QOL related to endometriosis had become better or a great deal better (score of greater than or equal to 6) since beginning PEEPS. | Posted | Number | percentage of participants | 8 weeks |
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| Secondary | Modified Every Day Discrimination Scale | To assess experiences of healthcare discrimination, this Modified Every Day Discrimination Scale was administered at baseline. It is a validated survey that assesses experience of discrimination in 10 potential domains. Percentage of participants reporting experiencing discrimination "at least a few times per year" or more frequently is reported. | 34 of 35 completed the measure. of these, 67.6% endorsed facing some kind of discrimination at least a few times a year. | Posted | Number | percentage of participants | Baseline |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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Not provided
Not provided
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |