Clinical trial NCT03154801: Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors (NEUROSEX)
Official title: Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Grade Glioma of Brain
Multiple Sclerosis
Sexual Dysfunctions
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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
3. Signature of informed consent
4. Patient affiliated to a social security system

Exclusion Criteria:

1. Minor patients
2. Pregnant women
3. Patients who do not understand and / or speak French and / or are unable to sign consent
4. Patients with neurological impairment
5. Patients with chronic sexual disorders who have already received treatment.
6. Patients with a HAD score (depression component) greater than 11
7. Patients with MS who had a corticosteroid-treated outbreak in the last two months.
8. Patients with low-grade glioma with clinical and / or radiological scalability during the last three months
9. Any patient whose alteration of the general state would not allow to follow the program.
10. Patients under legal protection

For patient's partners:

Inclusion criteria:

1. Any patient partner, whose patient has wished to participate and who has accepted.
2. Signing of informed consent

Non-Inclusion Criteria:

1. Minor partners
2. Pregnant women
3. Any person who does not understand and / or speak French and / or is unable to sign the consent
4. Partners under legal protection

Primary outcomes:
measure: Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
timeFrame: Inclusion and 3 months
Secondary outcomes:
measure: Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
timeFrame: Inclusion and 6-months
measure: Change of HAD scale (Hospital Anxiety and Depression)
timeFrame: Inclusion and 3 months
measure: Change of HAD scale (Hospital Anxiety and Depression)
timeFrame: Inclusion and 6 months
measure: Change of Rosenberg's Self-esteem Scale
timeFrame: Inclusion and 3 months
measure: Change of Rosenberg's Self-esteem Scale
timeFrame: Inclusion and 6 months
measure: Change of Quality of life scale
timeFrame: Inclusion and 3 months
measure: Change of Quality of life scale
timeFrame: Inclusion and 6 months
measure: Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)
timeFrame: Inclusion and 3 months
measure: Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)
timeFrame: Inclusion and 6 months
measure: Change of SEP59 scale (Sclérose En Plaques)
timeFrame: Inclusion and 3 months
measure: Change of SEP59 scale (Sclérose En Plaques)
timeFrame: Inclusion and 6 months
measure: Program satisfaction scale
timeFrame: 3 months
measure: Program satisfaction scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitie Salpetriere
Study officials:
References: