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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis; Low Grade Glioma of Brain; Sexual Dysfunctions
• Intervention / Treatment: Other: Paramedical care

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Groupe Hospitalier Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paramedical care; paramedical early detection of sexual dysfunction and sexual health counseling	Other: Paramedical care; Paramedical early detection of sexual dysfunction and sexual health counseling

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Actual): January 26, 2022
• Study Completion (Anticipated): July 26, 2022

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 14, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Nervous System Diseases
• Other Study ID Numbers: P140709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No