Low Grade Glioma of BrainNEUROSEXNCT03154801
Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors (NEUROSEX)
A study testing Paramedical care in people with Low Grade Glioma of Brain and Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Glioma of Brain, Multiple Sclerosis, Sexual Dysfunctions
- What is being tested?
- Paramedical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2017to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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".
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- A HAD questionnaire (depression component) with a score ≤ 11
- Signature of informed consent
- Patient affiliated to a social security system
- 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
Who cannot join
- 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
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- 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:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Paramedical care
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paramedical careOther
Paramedical early detection of sexual dysfunction and sexual health counseling
| Study group | Role | What they receive |
|---|---|---|
| Paramedical care | Experimental | paramedical early detection of sexual dysfunction and sexual health counseling Receives: Other: Paramedical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
Change of MSISQ15 sexual dysfunctional items at 3-months from baseline
Measured: Inclusion and 3 months
Secondary outcomes (13)
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
Change of MSISQ15 sexual dysfunctional items at 6-months from baseline
Measured: Inclusion and 6-months
Change of HAD scale (Hospital Anxiety and Depression)
Change of HAD scale score at 3-months from baseline
Measured: Inclusion and 3 months
Change of HAD scale (Hospital Anxiety and Depression)
Change of HAD scale score at 6-months from baseline
Measured: Inclusion and 6 months
Change of Rosenberg's Self-esteem Scale
Change of Rosenberg's Self-esteem Scale score at 3-months from baseline
Measured: Inclusion and 3 months
Change of Rosenberg's Self-esteem Scale
Change of Rosenberg's Self-esteem Scale score at 6-months from baseline
Measured: Inclusion and 6 months
Change of Quality of life scale
Change of Quality of life scale score at 3-months from baseline
Measured: Inclusion and 3 months
Change of Quality of life scale
Change of Quality of life scale score at 6-months from baseline
Measured: 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
Measured: 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
Measured: Inclusion and 6 months
Change of SEP59 scale (Sclérose En Plaques)
Change of SEP59 scale score at 3-months from baseline
Measured: Inclusion and 3 months
Change of SEP59 scale (Sclérose En Plaques)
Change of SEP59 scale score at 6-months from baseline
Measured: Inclusion and 6 months
Program satisfaction scale
Program satisfaction scale scores at 3-months
Measured: 3 months
Program satisfaction scale
Program satisfaction scale scores at 6-months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start26 Jul 2017
- Primary completion26 Jan 2022
- Study completion26 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154801
- Sponsor's protocol ID
- P140709
- Acronym
- NEUROSEX
- Status last verified
- Feb 2022
- First submitted
- 9 May 2017
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors
- ClinicalTrials.gov ID
- NCT03154801
- Acronym / sponsor ID
- NEUROSEX / P140709
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jul 2022 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paramedical care | Experimental | Other: Paramedical careparamedical early detection of sexual dysfunction and sexual health counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Any major patient with MS(Multiple Sclerosis), followed in the GHPSCF Department of Neurology:
- Signature of informed consent
- Patient affiliated to a social security system
- Any patient partner, whose patient has wished to participate and who has accepted.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paramedical careParamedical early detection of sexual dysfunction and sexual health counseling | Other | Paramedical care |
Primary outcome
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
13 secondary outcomes
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
Time frame: Inclusion and 6-months
Change of HAD scale (Hospital Anxiety and Depression)
Time frame: Inclusion and 3 months
Change of HAD scale (Hospital Anxiety and Depression)
Time frame: Inclusion and 6 months
Change of Rosenberg's Self-esteem Scale
Time frame: Inclusion and 3 months
Change of Rosenberg's Self-esteem Scale
Time frame: Inclusion and 6 months
Change of Quality of life scale
Time frame: Inclusion and 3 months
Change of Quality of life scale
Time frame: Inclusion and 6 months
Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)
Time frame: Inclusion and 3 months
Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)
Time frame: Inclusion and 6 months
Change of SEP59 scale (Sclérose En Plaques)
Time frame: Inclusion and 3 months
Change of SEP59 scale (Sclérose En Plaques)
Time frame: Inclusion and 6 months
Program satisfaction scale
Time frame: 3 months
Program satisfaction scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedical care in people with Low Grade Glioma of Brain and Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) (time frame: Inclusion and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.