NCT03154801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 26, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

4.5 years

First QC Date

May 9, 2017

Last Update Submit

February 17, 2022

Conditions

Low Grade Glioma of BrainMultiple SclerosisSexual Dysfunctions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

    Inclusion and 6-months

  • Change of HAD scale (Hospital Anxiety and Depression)

    Inclusion and 3 months

  • Change of HAD scale (Hospital Anxiety and Depression)

    Inclusion and 6 months

  • Change of Rosenberg's Self-esteem Scale

    Inclusion and 3 months

  • Change of Rosenberg's Self-esteem Scale

    Inclusion and 6 months

  • +8 more secondary outcomes

Study Arms (1)

Paramedical care

EXPERIMENTAL

paramedical early detection of sexual dysfunction and sexual health counseling

Other: Paramedical care

Interventions

Paramedical careOTHER

Paramedical early detection of sexual dysfunction and sexual health counseling

Paramedical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Any patient partner, whose patient has wished to participate and who has accepted.
  • Signing of informed consent
  • Minor partners
  • Pregnant women
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitie Salpetriere

Paris, 75013, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 16, 2017

Study Start

July 26, 2017

Primary Completion

January 26, 2022

Study Completion

July 26, 2022

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)