NCT03154801Unknown不适用
Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
时间窗: Inclusion and 3 months
Change of MSISQ15 sexual dysfunctional items at 3-months from baseline
次要结局
- 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)
研究者
研究点 (2)
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