Programme EducaTif d'Accompagnement pLuridisciplinaire Des Patientes Atteintes d'Endométriose
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 4
- 主要终点
- Endometriosis Health Profile-30 (EHP-30)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Endometriosis Health Profile-30 (EHP-30)
时间窗: baseline (T0) to 6 months and 12 months (M12)
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.
次要结局
- 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).)
- Hormonal treatments(baseline (T0) to 12 months)
- Analgesic medications(baseline (T0) to 12 months)
- medical consultations, hospitalizations, and work absences(baseline (T0) to 12 months (M12))
- the type and frequency of supportive care interventions(baseline (T0) and 12 months (M12))