Peer Empowered Endometriosis Pain Support for Endometriosis

(PEEPS RCT Trial)

Overseen By Whitney Ross, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Opioids

Disqualifiers: Pregnancy, Severe impairment, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use opioids frequently (5 days or more in the past 3 months), you may not be eligible to participate.

How is the PEEPS treatment for endometriosis different from other treatments?

The PEEPS treatment is unique because it focuses on peer support and education to empower women with endometriosis, helping them understand their condition and manage pain through shared experiences and knowledge, rather than relying solely on medical or surgical interventions. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Education, PEEPS, for endometriosis?

Research shows that educational programs can improve knowledge about menstrual pain and endometriosis, which may help women manage their symptoms better. Additionally, social support has been found to be a valuable resource for coping with endometriosis, suggesting that peer support could be beneficial. ^{2 4 5 6 7}

Who Is on the Research Team?

Whitney Ross, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-48 with surgically confirmed endometriosis and chronic pelvic pain lasting over six months. Participants must not plan surgery during the study, be able to attend at least six out of eight sessions in English on the Washington University campus.

Inclusion Criteria

I have had pelvic pain not just during periods for over 6 months.

I am comfortable reading and speaking English.

I can attend 6 out of 8 weekly sessions at Washington University.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Peer Empowered Endometriosis Pain Support (PEEPS) program, consisting of eight weekly two-hour sessions

8 weeks

8 visits (in-person)

Follow-up

Participants complete follow-up quality of life surveys and assessments at PEEPS completion, 6- and 12-months post-completion

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Education
• PEEPS

Trial Overview The trial tests Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week program, against standard Education to see if it better reduces pain interference. It includes group care sessions, quality of life surveys before and after the program, and follow-ups at 6 and 12 months.

How Is the Trial Designed?

Group I: Peer Empowered Endometriosis Pain Support (PEEPS) Experimental Treatment 1 Intervention

Participants in this arm will receive PEEPS plus usual care. PEEPS is comprised of eight weekly two-hour sessions delivered to groups of 6-10 participants. The sessions provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Participants additionally receive peer and clinician support.

Group II: Education Active Control 1 Intervention

Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A study involving 128 women with endometriosis showed that those who participated in a multi-professional group intervention experienced significant reductions in both pain and depression scores after the intervention.

The results suggest that group intervention can be an effective complementary treatment for managing pain and depression in women with endometriosis, highlighting the importance of psychological support in their overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of pain and depression in women with endometriosis after a multi- professional group intervention]. Lorençatto, C., Vieira, MJ., Marques, A., et al.[2019]

Women with endometriosis highly value social support, particularly from peers who understand their condition, as revealed by a study involving 46 participants in an online support group.

The study highlights that these women seek knowledgeable support networks and desire their healthcare providers to facilitate connections to information and resources about endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of lay organizations for coping with endometriosis. Whitney, ML.[2015]

The EndoWheel is a new patient-reported assessment tool designed to help women with endometriosis communicate their symptoms and the impact of the condition more effectively with healthcare providers, developed through a consensus process involving both patients and specialists.

In a study with 13 women, the tool was completed in about 5-6 minutes, and 92% of participants felt it would enhance discussions about their symptoms and treatment options, addressing areas often overlooked in standard consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a visual, patient-reported tool for assessing the multi-dimensional burden of endometriosis. As-Sanie, S., Laufer, MR., Missmer, SA., et al.[2021]

A multinational study involving 1911 young women (ages 19-24) showed that an educational program significantly improved knowledge about menstrual pain and endometriosis, particularly among nursing and medical students.

Despite the increase in knowledge, college students did not feel motivated to seek medical help for menstrual issues, while medical and nursing students showed a strong interest in consulting gynecologists for better management of their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A targeted educational programme improves fundamental knowledge of menstrual pain and endometriosis in young women: The Endometriosis Awareness Promotion Project. Khan, KN., Ogawa, K., Iwasa, K., et al.[2022]

This study aims to explore how women from diverse socioeconomic and racial backgrounds recognize, assess, and manage their endometriosis symptoms, using a qualitative approach with at least 24 participants.

By mapping the diagnostic pathways of these women, the research seeks to identify differences in their experiences, which could lead to improved interventions for achieving quicker diagnoses of endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inquiry into women's pathways to diagnosis of endometriosis: A qualitative study protocol. Cromeens, MG., Thoyre, S., Carey, ET., et al.[2022]

The 'Sex, Pain, and Endometriosis' website was found to be user-friendly and effective in providing evidence-based information about endometriosis and sexual pain, helping to empower users and reduce stigma around the condition.

While the website had minor usability issues, it was generally perceived as nonstigmatizing, and participants provided valuable feedback for improving website design to enhance privacy and inclusiveness for users seeking sensitive health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Educational Website for Women With Endometriosis-Associated Dyspareunia: Usability and Stigma Analysis. Abdulai, AF., Howard, AF., Yong, PJ., et al.[2022]

The MyEndosis Facebook group serves as a vital online support platform for women with endometriosis, where they discuss personal struggles, treatment options, and side effects, highlighting the importance of community in managing their condition.

Participants reported gaining various forms of support, including emotional and informational, which suggests that peer interactions can significantly enhance the experience of those dealing with endometriosis, an aspect that healthcare providers may not fully recognize.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the role of Facebook to support women with endometriosis: A Malaysian perspective. Wilson, S., Mogan, S., Kaur, K.[2020]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

[Evaluation of pain and depression in women with endometriosis after a multi- professional group intervention]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Importance of lay organizations for coping with endometriosis. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Development of a visual, patient-reported tool for assessing the multi-dimensional burden of endometriosis. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A targeted educational programme improves fundamental knowledge of menstrual pain and endometriosis in young women: The Endometriosis Awareness Promotion Project. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Inquiry into women's pathways to diagnosis of endometriosis: A qualitative study protocol. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Developing an Educational Website for Women With Endometriosis-Associated Dyspareunia: Usability and Stigma Analysis. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Understanding the role of Facebook to support women with endometriosis: A Malaysian perspective. [2020]