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Endometriosis and Pain (EndoDOL)

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychological and corporal group management
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis focused on measuring Endometriosis, Pain, group management, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >=18 years
  • Patients with deep endometriosis according to the CNGOF (collège national des Gynécologues et Obstétriciens Français) and/or chronic pain related to endometriosis according to doctor's evaluation and to the definitions of IASP (International Association for the Study of Pain) and HAS (French National Authority for Health) in treatment failure despite appropriate medical or surgical management of endometriosis
  • Patients with social security
  • Patients willing to come to all study visits
  • Patients who signed their informed consent

Exclusion Criteria:

  • Patients unable to participate in group care:

    • Patients with social phobia assessed during the inclusion interview
    • Patients with psychiatric disorders of a psychotic nature: delirium, hallucination, incoherent thoughts
    • Patients with behavioral disorders of hetero-aggressive or self-aggressive type oPatients with a handicap that prevents them following the physical and psychological group sessions (speech disorders, hearing, visual or practical)
  • Pregnant women
  • Patients planning a change (stop, start) during the study of their psychological management in their current care path.
  • Patients planning a change (stop, start) during the study of their treatment by non-medicinal techniques (auriculo-acupuncture, relaxation and self-hypnosis, transcutaneous neurostimulation by TENS)
  • Patients suffering from other severe or chronic somatic diseases associated with endometriosis
  • Patients with cognitive disorders
  • Patients with analgesics addiction (psychoactive substances, morphine substances, etc.)
  • Patients protected by law (under guardianship / trusteeship)
  • Patients participating in another interventional research that may interfere with the protocol results

Sites / Locations

  • Croix Rousse HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients suffering from severe endometriosis and chronic pain

Arm Description

Patients suffering from severe endometriosis and chronic pain that have been identified during a gynecological consultation (individual or during a multidisciplinary team meetings) or during a pain consultation on the same site of the Croix-Rousse Hospital and having signed a consent form

Outcomes

Primary Outcome Measures

Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
The Physical Composite Score (PCS) is based on four physical dimensions of quality of life and involves 8 components (Physical Functioning, Role Physical, Bodily Pain,General Health, Vitality, Social Functioning,Mental Health and Emotional Role). The evolution of the PCS is measured between T0, start of care, and the end of care (at T0 + 3 months). The PCS score ranges from 0 to 100, a higher score being associated with a better quality of life.

Secondary Outcome Measures

Evolution of pain: Visual Analogue Scale (VAS)
Evolution of pain assessed by the Visual Analogue Scale (VAS) between the beginning (T0) and the end of patient care (T0 + 3 months), in different body areas (back - abdomen - pelvic area - others) The VAS allows patients to rate their pain in an objective and comparable measure. This allows a quantitative evaluation of intensity of pain and trace evolution of the symptomatology in the same subject. The VAS ranges from 0 to 10, 0 for no pain, 10 for maximum pain.
Evolution of overall pain: Visual Analogue Scale (VAS)
Evolution of overall pain assessed by the Visual Analogue Scale (VAS) between the beginning (T0) and the end of patient care (T0 + 3 months) The VAS allows patients to rate their pain in an objective and comparable measure. This allows a quantitative evaluation of intensity of pain and trace evolution of the symptomatology in the same subject. The VAS ranges from 0 to 10, 0 for no pain, 10 for maximum pain.
Comparison of painful location on the body pain schema, before/after patient care
Comparison of painful location (circle by the patient on the body schema) before (T0)/after patient care (T0 + 3 months). Since endometriosis is synonymous with chronic and specific chronic pain (dyspareunia, dyschesia, cystalgia, for example), the body pain schema is a complementary tool in measurements, where the patient precisely surrounds the painful location (localizations of pain) and their extensions on a body schema,
Comparison of area of pain on the body pain schema, before/after patient care
Comparison of area of pain (circle by the patient on the body schema), before (T0)/after patient care (T0 + 3 months). Area of each pain location will be calculated using the Geocalcul.Plus software and will be compared between the beginning (T0) and the end of patient care (T0 + 3 months).
Comparison of results of the interview schedule
Comparison of results of the interview schedule before (T0) and after patient care (T0 + 3 months). Interview schedule examines two dimensions : Inter-individual: couple quality of life, sex life Intra-individual: self-image/body image, infertility, emotional life, pre or postoperative felt
Evolution of analgesics consumption
Consumption of analgesics at the end of the treatment (T0 + 3 months) is self-evaluated by the patient: decreased / stable / increased.
number of painful crises
Number of painful crises is the comparison of seizures number in the month preceding treatment with seizures number in the last month of care
Evolution of the Vitality (VT) score of the MOS SF36 score, before/after treatment
The evolution of the Vitality (VT) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The VT score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Social Function (SF) score of the MOS SF36 score, before/after treatment
The evolution of the Social Function (SF) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The SF score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Mental Health (MH) score of the MOS SF36 score, before/after treatment
The evolution of the Mental Health (MH) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The MH score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Role Emotional (RE) score of the MOS SF36 score, before/after treatment
The evolution of the Role Emotional (RE) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The RE score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Physical Function (PF) score of the MOS SF36 score, before/after treatment
The evolution of the Physical Function (PF) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The PF score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Role Physical (RP) score of the MOS SF36 score, before/after treatment
The evolution of the Role Physical (RP) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The RP score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Bodily Pain (BP) score of the MOS SF36 score, before/after treatment
The evolution of the Bodily Pain (BP) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The BP score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the General Health (GH) score of the MOS SF36 score, before/after treatment
The evolution of the General Health (GH) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The GH score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Health Thinking (HT) score of the MOS SF36 score, before/after treatment
The evolution of the Health Thinking (HT) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The HT score ranges from 0 to 100, a higher score being associated with a better quality of life.
Evolution of the Mental Component Score (MCS) of the MOS SF36 score, before/after treatment
The evolution of the Mental Component Score (MCS) is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The MCS ranges from 0 to 100, a higher score being associated with a better quality of life.
Evaluation of the patient compliance with group management sessions
The collection of the number of group sessions performed by the patient allows assessment of patient compliance with group management sessions. This evaluation allows to assess potential biases due to poor compliance in the final analysis.

Full Information

First Posted
June 5, 2019
Last Updated
December 29, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03993197
Brief Title
Endometriosis and Pain
Acronym
EndoDOL
Official Title
New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Psychological repercussions are very important and underestimated. Patient care focuses most often on the "organ pathology treatment ". This study proposes to evaluate a multidisciplinary patient care by insisting on anatomo-physiological pain management, psychological and bodily, in the perioperative phase. The main objective is to evaluate benefit of psychological and corporal group management on the overall quality of life of patients with severe endometriosis in terms of endometriotic damage and/or functional and painful repercussions, requiring surgery, before or after this study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Pain, group management, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients suffering from severe endometriosis and chronic pain
Arm Type
Experimental
Arm Description
Patients suffering from severe endometriosis and chronic pain that have been identified during a gynecological consultation (individual or during a multidisciplinary team meetings) or during a pain consultation on the same site of the Croix-Rousse Hospital and having signed a consent form
Intervention Type
Behavioral
Intervention Name(s)
Psychological and corporal group management
Intervention Description
After inclusion, patient will be divided into groups of 6 or 8 patients either in pre-operative or post-operative phase. Patient care will take place entirely in pre-operative or post-operative phase. Each group will benefit of six one hour and a half sessions. The frequency is established as follows: First week a session of Body Strategy © Second week a psychological session with group of speech (Photolanguage ©). Third week is a break Then the cycle currently described is repeated, for a total of 6 alternate sessions
Primary Outcome Measure Information:
Title
Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
Description
The Physical Composite Score (PCS) is based on four physical dimensions of quality of life and involves 8 components (Physical Functioning, Role Physical, Bodily Pain,General Health, Vitality, Social Functioning,Mental Health and Emotional Role). The evolution of the PCS is measured between T0, start of care, and the end of care (at T0 + 3 months). The PCS score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Evolution of pain: Visual Analogue Scale (VAS)
Description
Evolution of pain assessed by the Visual Analogue Scale (VAS) between the beginning (T0) and the end of patient care (T0 + 3 months), in different body areas (back - abdomen - pelvic area - others) The VAS allows patients to rate their pain in an objective and comparable measure. This allows a quantitative evaluation of intensity of pain and trace evolution of the symptomatology in the same subject. The VAS ranges from 0 to 10, 0 for no pain, 10 for maximum pain.
Time Frame
at 3 months
Title
Evolution of overall pain: Visual Analogue Scale (VAS)
Description
Evolution of overall pain assessed by the Visual Analogue Scale (VAS) between the beginning (T0) and the end of patient care (T0 + 3 months) The VAS allows patients to rate their pain in an objective and comparable measure. This allows a quantitative evaluation of intensity of pain and trace evolution of the symptomatology in the same subject. The VAS ranges from 0 to 10, 0 for no pain, 10 for maximum pain.
Time Frame
at 3 months
Title
Comparison of painful location on the body pain schema, before/after patient care
Description
Comparison of painful location (circle by the patient on the body schema) before (T0)/after patient care (T0 + 3 months). Since endometriosis is synonymous with chronic and specific chronic pain (dyspareunia, dyschesia, cystalgia, for example), the body pain schema is a complementary tool in measurements, where the patient precisely surrounds the painful location (localizations of pain) and their extensions on a body schema,
Time Frame
at 3 months
Title
Comparison of area of pain on the body pain schema, before/after patient care
Description
Comparison of area of pain (circle by the patient on the body schema), before (T0)/after patient care (T0 + 3 months). Area of each pain location will be calculated using the Geocalcul.Plus software and will be compared between the beginning (T0) and the end of patient care (T0 + 3 months).
Time Frame
at 3 months
Title
Comparison of results of the interview schedule
Description
Comparison of results of the interview schedule before (T0) and after patient care (T0 + 3 months). Interview schedule examines two dimensions : Inter-individual: couple quality of life, sex life Intra-individual: self-image/body image, infertility, emotional life, pre or postoperative felt
Time Frame
at 3 months
Title
Evolution of analgesics consumption
Description
Consumption of analgesics at the end of the treatment (T0 + 3 months) is self-evaluated by the patient: decreased / stable / increased.
Time Frame
at 3 months
Title
number of painful crises
Description
Number of painful crises is the comparison of seizures number in the month preceding treatment with seizures number in the last month of care
Time Frame
at 3 months
Title
Evolution of the Vitality (VT) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Vitality (VT) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The VT score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Social Function (SF) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Social Function (SF) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The SF score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Mental Health (MH) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Mental Health (MH) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The MH score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Role Emotional (RE) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Role Emotional (RE) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The RE score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Physical Function (PF) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Physical Function (PF) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The PF score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Role Physical (RP) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Role Physical (RP) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The RP score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Bodily Pain (BP) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Bodily Pain (BP) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The BP score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the General Health (GH) score of the MOS SF36 score, before/after treatment
Description
The evolution of the General Health (GH) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The GH score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Health Thinking (HT) score of the MOS SF36 score, before/after treatment
Description
The evolution of the Health Thinking (HT) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The HT score ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evolution of the Mental Component Score (MCS) of the MOS SF36 score, before/after treatment
Description
The evolution of the Mental Component Score (MCS) is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months). The MCS ranges from 0 to 100, a higher score being associated with a better quality of life.
Time Frame
at 3 months
Title
Evaluation of the patient compliance with group management sessions
Description
The collection of the number of group sessions performed by the patient allows assessment of patient compliance with group management sessions. This evaluation allows to assess potential biases due to poor compliance in the final analysis.
Time Frame
at 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >=18 years Patients with deep endometriosis according to the CNGOF (collège national des Gynécologues et Obstétriciens Français) and/or chronic pain related to endometriosis according to doctor's evaluation and to the definitions of IASP (International Association for the Study of Pain) and HAS (French National Authority for Health) in treatment failure despite appropriate medical or surgical management of endometriosis Patients with social security Patients willing to come to all study visits Patients who signed their informed consent Exclusion Criteria: Patients unable to participate in group care: Patients with social phobia assessed during the inclusion interview Patients with psychiatric disorders of a psychotic nature: delirium, hallucination, incoherent thoughts Patients with behavioral disorders of hetero-aggressive or self-aggressive type oPatients with a handicap that prevents them following the physical and psychological group sessions (speech disorders, hearing, visual or practical) Pregnant women Patients planning a change (stop, start) during the study of their psychological management in their current care path. Patients planning a change (stop, start) during the study of their treatment by non-medicinal techniques (auriculo-acupuncture, relaxation and self-hypnosis, transcutaneous neurostimulation by TENS) Patients suffering from other severe or chronic somatic diseases associated with endometriosis Patients with cognitive disorders Patients with analgesics addiction (psychoactive substances, morphine substances, etc.) Patients protected by law (under guardianship / trusteeship) Patients participating in another interventional research that may interfere with the protocol results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Branche, MD
Phone
472 072 581
Ext
+33
Email
patricia.branche@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Demahis
Phone
426 109 012
Ext
+33
Email
marie.demahis@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Branche, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croix Rousse Hospital
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Branche, MD
Phone
472 072 581
Ext
+33
First Name & Middle Initial & Last Name & Degree
Patricia Branche

12. IPD Sharing Statement

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Endometriosis and Pain

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