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

Primary Purpose

Low Grade Glioma of Brain, Multiple Sclerosis, Sexual Dysfunctions

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Paramedical care

About this trial

This is an interventional treatment trial for Low Grade Glioma of Brain

Eligibility Criteria

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

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

Sites / Locations

Groupe Hospitalier Pitie Salpetriere

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paramedical care

Arm Description

paramedical early detection of sexual dysfunction and sexual health counseling

Outcomes

Primary Outcome Measures

Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

Change of MSISQ15 sexual dysfunctional items at 3-months from baseline

Secondary Outcome Measures

Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

Change of MSISQ15 sexual dysfunctional items at 6-months from baseline

Change of HAD scale (Hospital Anxiety and Depression)

Change of HAD scale score at 3-months from baseline

Change of HAD scale (Hospital Anxiety and Depression)

Change of HAD scale score at 6-months from baseline

Change of Rosenberg's Self-esteem Scale

Change of Rosenberg's Self-esteem Scale score at 3-months from baseline

Change of Rosenberg's Self-esteem Scale

Change of Rosenberg's Self-esteem Scale score at 6-months from baseline

Change of Quality of life scale

Change of Quality of life scale score at 3-months from baseline

Change of Quality of life scale

Change of Quality of life scale score at 6-months from baseline

Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)

Change of QLQC30/BM20 score at 3-months from baseline

Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)

Assessment of QLQC30/BM20 score at 6-months from baseline

Change of SEP59 scale (Sclérose En Plaques)

Change of SEP59 scale score at 3-months from baseline

Change of SEP59 scale (Sclérose En Plaques)

Change of SEP59 scale score at 6-months from baseline

Program satisfaction scale

Program satisfaction scale scores at 3-months

Program satisfaction scale

Program satisfaction scale scores at 6-months

Full Information

NCT ID

NCT03154801

First Posted

May 9, 2017

Last Updated

February 17, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT03154801

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 26, 2017 (Actual)

Primary Completion Date

January 26, 2022 (Actual)

Study Completion Date

July 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Grade Glioma of Brain, Multiple Sclerosis, Sexual Dysfunctions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paramedical care

Arm Type

Experimental

Arm Description

paramedical early detection of sexual dysfunction and sexual health counseling

Intervention Type

Other

Intervention Name(s)

Paramedical care

Intervention Description

Paramedical early detection of sexual dysfunction and sexual health counseling

Primary Outcome Measure Information:

Title

Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

Description

Change of MSISQ15 sexual dysfunctional items at 3-months from baseline

Time Frame

Inclusion and 3 months

Secondary Outcome Measure Information:

Title

Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

Description

Change of MSISQ15 sexual dysfunctional items at 6-months from baseline

Time Frame

Inclusion and 6-months

Title

Change of HAD scale (Hospital Anxiety and Depression)

Description

Change of HAD scale score at 3-months from baseline

Time Frame

Inclusion and 3 months

Title

Change of HAD scale (Hospital Anxiety and Depression)

Description

Change of HAD scale score at 6-months from baseline

Time Frame

Inclusion and 6 months

Title

Change of Rosenberg's Self-esteem Scale

Description

Change of Rosenberg's Self-esteem Scale score at 3-months from baseline

Time Frame

Inclusion and 3 months

Title

Change of Rosenberg's Self-esteem Scale

Description

Change of Rosenberg's Self-esteem Scale score at 6-months from baseline

Time Frame

Inclusion and 6 months

Title

Change of Quality of life scale

Description

Change of Quality of life scale score at 3-months from baseline

Time Frame

Inclusion and 3 months

Title

Change of Quality of life scale

Description

Change of Quality of life scale score at 6-months from baseline

Time Frame

Inclusion and 6 months

Title

Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)

Description

Change of QLQC30/BM20 score at 3-months from baseline

Time Frame

Inclusion and 3 months

Title

Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)

Description

Assessment of QLQC30/BM20 score at 6-months from baseline

Time Frame

Inclusion and 6 months

Title

Change of SEP59 scale (Sclérose En Plaques)

Description

Change of SEP59 scale score at 3-months from baseline

Time Frame

Inclusion and 3 months

Title

Change of SEP59 scale (Sclérose En Plaques)

Description

Change of SEP59 scale score at 6-months from baseline

Time Frame

Inclusion and 6 months

Title

Program satisfaction scale

Description

Program satisfaction scale scores at 3-months

Time Frame

3 months

Title

Program satisfaction scale

Description

Program satisfaction scale scores at 6-months

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Groupe Hospitalier Pitie Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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