Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors (NEUROSEX)

Study Overview
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Brief Summary
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This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.

Official Title
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Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors

Conditions
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Low Grade Glioma of Brain, Multiple Sclerosis, Sexual Dysfunctions

Intervention / Treatment
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* Other: Paramedical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any major patient, followed in the GHPSCF (Groupe Hospitalier Pitié-Salpêtrière Charles Foix) neurology department 2 for a diagnosis of low grade glioma or anaplastic glioma with loss 1p / 19q sub-reserve histo-molecular confirmation after national reading (POLA) and presenting: An MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) questionnaire with at least one of the items rated 4 or 5 and A HAD (Hospital Anxiety and Depression) questionnaire (depression component) with a score ≤ 11 Any major patient with MS(Multiple Sclerosis), followed in the GHPSCF Department of Neurology: With an EDSS (Expanded Disability Status Scale) greater than or equal to 1 and An MSISQ15 questionnaire with at least one of the items rated 4 or 5. A HAD questionnaire (depression component) with a score ≤ 11 Signature of informed consent Patient affiliated to a social security system Exclusion Criteria: Minor patients Pregnant women Patients who do not understand and / or speak French and / or are unable to sign consent Patients with neurological impairment Patients with chronic sexual disorders who have already received treatment. Patients with a HAD score (depression component) greater than 11 Patients with MS who had a corticosteroid-treated outbreak in the last two months. Patients with low-grade glioma with clinical and / or radiological scalability during the last three months Any patient whose alteration of the general state would not allow to follow the program. Patients under legal protection For patient's partners: Inclusion criteria: Any patient partner, whose patient has wished to participate and who has accepted. Signing of informed consent Non-Inclusion Criteria: Minor partners Pregnant women Any person who does not understand and / or speak French and / or is unable to sign the consent Partners under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paramedical care<br>paramedical early detection of sexual dysfunction and sexual health counseling | Other: Paramedical care<br>* Paramedical early detection of sexual dysfunction and sexual health counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) | Change of MSISQ15 sexual dysfunctional items at 3-months from baseline | Inclusion and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) | Change of MSISQ15 sexual dysfunctional items at 6-months from baseline | Inclusion and 6-months | 
| Change of HAD scale (Hospital Anxiety and Depression) | Change of HAD scale score at 3-months from baseline | Inclusion and 3 months | 
| Change of HAD scale (Hospital Anxiety and Depression) | Change of HAD scale score at 6-months from baseline | Inclusion and 6 months | 
| Change of Rosenberg's Self-esteem Scale | Change of Rosenberg's Self-esteem Scale score at 3-months from baseline | Inclusion and 3 months | 
| Change of Rosenberg's Self-esteem Scale | Change of Rosenberg's Self-esteem Scale score at 6-months from baseline | Inclusion and 6 months | 
| Change of Quality of life scale | Change of Quality of life scale score at 3-months from baseline | Inclusion and 3 months | 
| Change of Quality of life scale | Change of Quality of life scale score at 6-months from baseline | Inclusion and 6 months | 
| Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module) | Change of QLQC30/BM20 score at 3-months from baseline | Inclusion and 3 months | 
| Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module) | Assessment of QLQC30/BM20 score at 6-months from baseline | Inclusion and 6 months | 
| Change of SEP59 scale (Sclérose En Plaques) | Change of SEP59 scale score at 3-months from baseline | Inclusion and 3 months | 
| Change of SEP59 scale (Sclérose En Plaques) | Change of SEP59 scale score at 6-months from baseline | Inclusion and 6 months | 
| Program satisfaction scale | Program satisfaction scale scores at 3-months | 3 months | 
| Program satisfaction scale | Program satisfaction scale scores at 6-months | 6 months |