EndometriosisPETALENCT07134023
Educational Program for the Multidisciplinary Support of Patients With Endometriosis
A study testing Supportive Care in people with Endometriosis, run by Centre Hospitalier Emile Roux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Dec 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clinique Axium
Aix-en-Provence, 13100
Lola COURBON VENTRE, +334 42 95 72 72
- Not yet recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Eve DEFOUS, +334.71.04.14.61
About this study
Official title: Programme EducaTif d'Accompagnement pLuridisciplinaire Des Patientes Atteintes d'Endométriose
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.
Read more
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
- Being tested
- Supportive Care
- Keywords
- Endometriosis, Quality of life, Multidisciplinary, Nurse follow-up
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Supportive Care |
| Control group | No intervention | Patients follow conventional care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (T0) to 6 months and 12 months (M12)
Secondary outcomes (9)
Anxiety
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.
Measured: baseline (T0), 6 months (M6), and 12 months (M12).
Score of the the brief pain inventory
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.
Measured: baseline (T0), 6 months (M6), and 12 months (M12).
dyspareunia and dysmenorrhea
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.
Measured: baseline (T0), 6 months (M6), and 12 months (M12)
Female Sexual Function
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.
Measured: baseline (T0), 6 months (M6), and 12 months (M12).
Sleep
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."
Measured: baseline (T0), 6 months (M6), and 12 months (M12).
Hormonal treatments
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)
Measured: baseline (T0) to 12 months
Analgesic medications
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).
Measured: baseline (T0) to 12 months
medical consultations, hospitalizations, and work absences
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).
Measured: baseline (T0) to 12 months (M12)
the type and frequency of supportive care interventions
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).
Measured: baseline (T0) and 12 months (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start17 Dec 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134023
- Sponsor's protocol ID
- RIPH2_DEFOUS_PETALE
- Other IDs
- ID RCB
- Acronym
- PETALE
- Status last verified
- Dec 2025
- First submitted
- 7 Aug 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programme EducaTif d'Accompagnement pLuridisciplinaire Des Patientes Atteintes d'Endométriose
- ClinicalTrials.gov ID
- NCT07134023
- Acronym / sponsor ID
- PETALE / RIPH2_DEFOUS_PETALE
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Quality of life, Multidisciplinary, Nurse follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group will participate in a therapeutic education and nursing support | Experimental | Other: Supportive CareTherapeutic 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. |
| Control group | No intervention | –Patients follow conventional care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CareInitial 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. | Other | The experimental group will participate in a therapeutic education and nursing support |
Primary outcome
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.
9 secondary outcomes
Anxiety
Time frame: baseline (T0), 6 months (M6), and 12 months (M12).
Score of the the brief pain inventory
Time frame: baseline (T0), 6 months (M6), and 12 months (M12).
dyspareunia and dysmenorrhea
Time frame: baseline (T0), 6 months (M6), and 12 months (M12)
Female Sexual Function
Time frame: baseline (T0), 6 months (M6), and 12 months (M12).
Sleep
Time frame: baseline (T0), 6 months (M6), and 12 months (M12).
Hormonal treatments
Time frame: baseline (T0) to 12 months
Analgesic medications
Time frame: baseline (T0) to 12 months
medical consultations, hospitalizations, and work absences
Time frame: baseline (T0) to 12 months (M12)
the type and frequency of supportive care interventions
Time frame: baseline (T0) and 12 months (M12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care in people with Endometriosis, run by Centre Hospitalier Emile Roux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Gadéa, PhD (+33 4 71 04 35 38, petale@ch-lepuy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis Health Profile-30 (EHP-30) (time frame: baseline (T0) to 6 months and 12 months (M12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.