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NCT Number: NCT07134023

Educational Program for the Multidisciplinary Support of Patients With Endometriosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Axium, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Endometriosis Health Profile-30 (EHP-30)

    Time frame: 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.

Secondary outcomes

  1. Anxiety

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

    Change in anxiety and depression scores, measured using the validated self-administered Hospital Anxiety and Depression Scale (HADS), between the experimental group and the control group at baseline (T0), 6 months (M6), and 12 months (M12).

    This 14-item questionnaire, rated from 0 to 3, is used to detect anxiety or depression. The score obtained for each component (seven items for the anxiety component and seven items for the depression component) is analyzed. The maximum possible score for each component is 21. A score of seven or less indicates an absence of symptoms; a score between eight and 10 indicates possible symptoms; and a score of 11 or more indicates definite symptoms.

  2. Score of the the brief pain inventory

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

    Change in pain scores, assessed using the Brief Pain Inventory (BPI), a validated self-administered questionnaire evaluating pain location, intensity, and interference with daily activities, between the experimental group and the control group at baseline (T0), 6 months (M6), and 12 months (M12).

    This self-questionnaire allows you to evaluate various aspects of pain, such as its location, intensity, and frequency. Pain intensity is evaluated using a scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain imaginable.

  3. dyspareunia and dysmenorrhea

    Time frame: baseline (T0), 6 months (M6), and 12 months (M12)

    Change in pain scores related to dyspareunia and dysmenorrhea, assessed using a Visual Analogue Scale (VAS), between the experimental group and the control group at baseline (T0), 6 months (M6), and 12 months (M12).

    This validated self-administered scale allows participants to rate the intensity of their pain along a continuous line, typically 0-10, where higher scores indicate greater pain.

  4. Female Sexual Function

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

    Change in sexual function, assessed using the Female Sexual Function Index (FSFI), a validated self-administered questionnaire evaluating sexual function in women, between the experimental group and the control group at baseline (T0), 6 months (M6), and 12 months (M12).

    This self-report questionnaire assesses sexual function in women. It contains 19 items, which are divided into six domains. Each item is rated on a scale from 0 to 6. The total score is obtained by adding together the scores for each domain. Higher scores indicate better sexual function and quality of life.

  5. Sleep

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

    Change in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-administered questionnaire evaluating sleep disturbances and overall sleep quality, between the experimental group and the control group at baseline (T0), 6 months (M6), and 12 months (M12).

    PSQI is a validated, 19-item, self-administered questionnaire that measures sleep problems. A score of 5 or less indicates "good sleepers," while a score strictly greater than 5 indicates "poor sleepers."

  6. Hormonal treatments

    Time frame: baseline (T0) to 12 months

    Use of hormonal treatments, including information on the International Nonproprietary Name (INN), daily dosage, and duration of use, in the experimental group versus the control group from baseline (T0) to 12 months (M12)

  7. Analgesic medications

    Time frame: baseline (T0) to 12 months

    Use of analgesic medications, including the INN, daily dosage, and duration of use, in the experimental group versus the control group from baseline (T0) to 12 months (M12).

  8. medical consultations, hospitalizations, and work absences

    Time frame: baseline (T0) to 12 months (M12)

    Number of medical consultations, hospitalizations, and work absences related to endometriosis between the experimental group and the control group from baseline (T0) to 12 months (M12).

  9. the type and frequency of supportive care interventions

    Time frame: baseline (T0) and 12 months (M12)

    Type and frequency of supportive care interventions used by patients in the experimental group versus the control group between baseline (T0) and 12 months (M12).

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie Gadéa, PhD

CONTACT

[email protected]

+33 4 71 04 35 38

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Registry information

Official study title

Programme EducaTif d'Accompagnement pLuridisciplinaire Des Patientes Atteintes d'Endométriose

Acronym: PETALE

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 21, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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