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Clinical Trials/NCT03154801
NCT03154801UnknownNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country54 target enrollmentStarted: July 26, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
54
Locations
1
Primary Endpoint
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Paramedical care

Experimental

paramedical early detection of sexual dysfunction and sexual health counseling

Intervention: Paramedical care (Other)

Outcomes

Primary Outcomes

Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

Time Frame: Inclusion and 3 months

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

Secondary Outcomes

  • Program satisfaction scale(6 months)
  • Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)(Inclusion and 6-months)
  • Change of HAD scale (Hospital Anxiety and Depression)(Inclusion and 6 months)
  • Change of Rosenberg's Self-esteem Scale(Inclusion and 6 months)
  • Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)(Inclusion and 6 months)
  • Change of Quality of life scale(Inclusion and 6 months)
  • Change of SEP59 scale (Sclérose En Plaques)(Inclusion and 6 months)
  • Change of HAD scale (Hospital Anxiety and Depression)(Inclusion and 3 months)
  • Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)(Inclusion and 3 months)
  • Change of Rosenberg's Self-esteem Scale(Inclusion and 3 months)
  • Change of Quality of life scale(Inclusion and 3 months)
  • Change of SEP59 scale (Sclérose En Plaques)(Inclusion and 3 months)
  • Program satisfaction scale(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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