Peer Empowered Endometriosis Pain Support for Endometriosis

(PEEPS RCT Trial)

Recruiting at 1 trial location

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?

This trial aims to determine if the Peer Empowered Endometriosis Pain Support (PEEPS) program can reduce pain impact in individuals with endometriosis, a condition causing chronic pelvic pain. Researchers will compare two groups: one receiving PEEPS alongside usual care and another receiving only educational materials and usual care. Participants will engage in sessions covering mindfulness, yoga, nutrition, and pain management strategies. Individuals with surgically confirmed endometriosis, who experience pelvic pain outside of their menstrual period, and can attend sessions in English at Washington University may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative pain management strategies and contribute to advancing endometriosis care.

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.

What prior data suggests that the Peer Empowered Endometriosis Pain Support (PEEPS) program is safe?

Research has shown that the Peer Empowered Endometriosis Pain Support (PEEPS) program helps manage ongoing pelvic pain in people with endometriosis. PEEPS includes eight weekly group sessions covering topics such as understanding endometriosis, mindfulness, yoga, nutrition, and coping strategies for chronic pain.

While specific safety data for PEEPS is not detailed, similar group programs typically involve non-invasive activities. These programs are generally safe and unlikely to cause harm, as they do not involve medications or surgeries.

Participants in similar programs have reported benefits such as reduced pain and improved quality of life. With support from peers and healthcare professionals, PEEPS provides a safe space for participants to learn about managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Peer Empowered Endometriosis Pain Support (PEEPS) because it offers a holistic approach to managing endometriosis pain, which is different from typical treatments like pain medications and hormonal therapy. Unlike these standard options, PEEPS combines education with mindfulness, yoga, nutrition, and strategies for coping with chronic pain, all provided in a supportive group setting. This integrative method not only addresses physical symptoms but also aims to enhance overall well-being and mental health, potentially offering a more comprehensive and empowering way to manage the condition.

What evidence suggests that this trial's treatments could be effective for endometriosis-associated chronic pelvic pain?

Research shows that the Peer Empowered Endometriosis Pain Support (PEEPS) program, which participants in this trial may receive, can reduce the impact of pain on daily life for people with endometriosis. Earlier studies suggest that those who participate in PEEPS experience a greater reduction in pain's effect on their daily activities. The program includes sessions on mindfulness, yoga, nutrition, and other chronic pain management techniques, along with support from peers and healthcare professionals. While specific data is still being gathered, the comprehensive approach of PEEPS appears promising in improving the quality of life for those dealing with endometriosis pain. Meanwhile, participants in another arm of this trial will receive an educational handout covering the basics of endometriosis pathophysiology, diagnosis, and treatment. ^{1 3 6 7 8}

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

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05622955

Study Details | NCT05622955 | Endometriosis Group Care The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40044193/

protocol for a pilot randomised controlled trial at an urban ... We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion.

3. ctv.veeva.com ctv.veeva.com/study/endometriosis-group-care

Endometriosis Group Care (PEEPS) - ClinicalTrials.Veeva The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06549985?cond=%22Pelvic%20Pain%22&aggFilters=status:not%20rec&rank=8

Study Details | NCT06549985 | Interdisciplinary Group ... PEEPS is comprised of eight weekly two-hour sessions delivered to groups of 6-10 participants. The sessions provide education on endometriosis, ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/3/e097372

protocol for a pilot randomised controlled trial at an urban ... We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11883614/

protocol for a pilot randomised controlled trial at an urban ... We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion.

7. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/3/e097372.full.pdf

Does interdisciplinary group care for the treatment of ... Data on medical and psychosocial history, prior and current treatments for endometriosis (medications, physical therapy, surgery, counselling, ...

8. trialx.com trialx.com/clinical-trials/listings/317268/interdisciplinary-group-care-for-the-treatment-of-endometriosis-associated-pain/

Interdisciplinary Group Care for the Treatment of ... The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care ...