Educational Program for the Multidisciplinary Support of Patients With Endometriosis
NCT ID: NCT07134023
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
260 participants
INTERVENTIONAL
2025-12-17
2029-01-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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The experimental group will participate in a therapeutic education and nursing support
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.
Supportive Care
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.
Control group
Patients follow conventional care.
No interventions assigned to this group
Interventions
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Supportive Care
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Emile Roux
OTHER
Responsible Party
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Locations
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Clinique Axium
Aix-en-Provence, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
Countries
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Central Contacts
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Facility Contacts
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Lola COURBON VENTRE
Role: primary
Eve DEFOUS
Role: primary
Other Identifiers
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ID RCB
Identifier Type: OTHER
Identifier Source: secondary_id
RIPH2_DEFOUS_PETALE
Identifier Type: -
Identifier Source: org_study_id