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

Not Applicable

• Conditions: Multiple Sclerosis; Low Grade Glioma of Brain; Sexual Dysfunctions
• Interventions: Other: Paramedical care

• Registration Number: NCT03154801
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-14
• Study First Posted: 2017-05-16
• Study Start: 2017-07-26
• Primary Completion: 2022-01-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18
• Study Completion: 2022-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paramedical care	Paramedical care	paramedical early detection of sexual dysfunction and sexual health counseling

Primary Outcome Measures

Name	Time	Method
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)	Inclusion and 3 months	Change of MSISQ15 sexual dysfunctional items at 3-months from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Groupe Hospitalier Pitie Salpetriere; 🇫🇷 Paris, France