Educational Program for the Multidisciplinary Support of Patients With Endometriosis

NCT07134023 | Recruiting

• 2 other identifiers: RIPH2_DEFOUS_PETALEID RCB
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Endometriosis is a chronic gynecological condition characterized by the ectopic presence of endometrial tissue outside the uterine cavity. It affects approximately 2 to 10% of women of reproductive age and up to 50% of women with chronic pelvic pain. In France, between 1.5 and 2.5 million women are estimated to be affected. Endometriosis significantly impairs quality of life, with consequences on cognitive, behavioral, sexual, and emotional well-being, and has substantial socio-economic impact. Rationale: Current medical and surgical treatments primarily aim to reduce pain and preserve fertility but show limited effectiveness and are often discontinued due to adverse effects. Many women resort to self-management strategies, which may pose risks if not properly supervised. A multidisciplinary and integrative approach is essential to address the complex and multifactorial symptoms of endometriosis. Therapeutic patient education (TPE) is a recommended strategy that can empower patients in the management of chronic conditions, yet remains underdeveloped in endometriosis care pathways. Objective: This study aims to evaluate the effectiveness of a multidisciplinary educational program combined with nurse-led telephone follow-up on the quality of life of patients with endometriosis. Methods: The intervention will consist of a series of workshops led by various healthcare professionals (medical and paramedical), alongside regular nurse-led telephone follow-up. This approach intends to provide continuous support, assess patients' evolving needs, and facilitate access to supportive care services, particularly within regional endometriosis networks (ENDAURA and ENDOSUD). Expected Outcomes: The study will assess whether this intervention improves quality of life among women with endometriosis. It also aims to provide evidence for the scalability and transferability of such a program at a national level, in alignment with current public health priorities.

Conditions

Endometriosis

Keywords

Endometriosis; Quality of life; Multidisciplinary; Nurse follow-up

Outcome Measures

Primary Outcomes (1)

• Endometriosis Health Profile-30 (EHP-30)

  Change in quality of life, measured by the Endometriosis Health Profile-30 (EHP-30) score, from baseline (T0) to 12 months (M12), in the experimental group receiving a multidisciplinary educational program with nurse-led telephone follow-up compared with the control group receiving standard care.

  baseline (T0) to 6 months and 12 months (M12)

Secondary Outcomes (9)

• Anxiety

  baseline (T0), 6 months (M6), and 12 months (M12).

• Score of the the brief pain inventory

  baseline (T0), 6 months (M6), and 12 months (M12).

• dyspareunia and dysmenorrhea

  baseline (T0), 6 months (M6), and 12 months (M12)

• Female Sexual Function

  baseline (T0), 6 months (M6), and 12 months (M12).

• Sleep

  baseline (T0), 6 months (M6), and 12 months (M12).

Study Arms (2)

The experimental group will participate in a therapeutic education and nursing support

EXPERIMENTAL

Therapeutic Education and Nursing Support Program for Supportive Care. In addition to conventional gynecological follow-up care, patients will participate in an initial educational assessment day. During this day, the patient will have a discussion with the pivot nurse to define personalized objectives, which will guide the choice of workshops and supportive care in the outpatient educational program.

Other: Supportive Care

Control group

NO INTERVENTION

Patients follow conventional care.

Interventions

Supportive Care OTHER

Initial Educational Assessment In addition to standard care, patients will meet the coordinating nurse for an initial educational assessment to evaluate their needs and present the multidisciplinary workshop program and individual support options. The nurse will register the patient for the first session, provide program materials, schedule the first follow-up call (1 month post-inclusion), and collect study questionnaires and demographics. If needed, the assessment may be scheduled within 15 days of inclusion. Educational Workshops Patients may attend workshops on topics like endometriosis, diet, sexuality, pain, fatigue, emotions, Pilates, non-drug symptom management, hypnoanalgesia, and fertility. At least three workshops are required, offered over two days. Telephone Follow-up Monthly calls for 6 months, then at 9 and 12 months, will monitor symptoms and refer patients to support services as needed.

The experimental group will participate in a therapeutic education and nursing support

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent,
• Age ≥ 18 years,
• Patient diagnosed with endometriosis confirmed by pelvic ultrasound and/or MRI,
• Patient experiencing chronic pelvic-perineal pain (± dysmenorrhea, dyspareunia, etc.) for at least 3 months,
• Ability to read and understand French,
• Affiliation with a social security system or equivalent.

You may not qualify if:

• Patient having already participated in an educational program or received multidisciplinary follow-up (involving at least 3 different healthcare professionals simultaneously within the same facility) in the past 12 months,
• Patient in an emergency situation, or under legal protection measures (guardianship, curatorship, or judicial protection) and unable to give consent,
• For patients at the experimental center only: inability to comply with study follow-up due to geographical, social, or psychological reasons.

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead

Study Sites (2)

Clinique Axium

Aix-en-Provence, 13100, France

RECRUITING

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Emilie Gadéa, PhD

CONTACT

+33 4 71 04 35 38; petale@ch-lepuy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 21, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)