Study of the Sexual Health of Patients Treated for Non-metastatic Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital : a Prospective Monocentric Cohort With Repeated Anonymous Self-administered Questionnaires.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- variation of score FSFI (female sexual function index)
研究概览
简要总结
Study of sexual health by repeated anonymous self-administered questionnaires in patients treated for non-metastatic breast cancer and referred to Jeanne de Flandre hospital for possible preservation of their fertility. Sexual health is affected by treatments and improves after the treatments. Sexual health is influenced by multiple factors : oncology treatments received, self-esteem, body image, anxiety, depression, professional activity
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female from 18 years
- •In a relationship with a man or a woman
- •Developing invasive carcinoma of breast cancer
- •Planned medical therapy project by chemotherapy
- •Followed up in the Observatory of fertility
- •Patient who gave written consent to participate in the study
- •Insured Social Patient
- •Patient willing to follow all study procedures and duration
排除标准
- 未提供
结局指标
主要结局
variation of score FSFI (female sexual function index)
时间窗: At 1 year after the start of chemotherapy
The FSFI score assesses female sexual functioning over the past four weeks. It is a self-evaluation by questionnaire. It consists of 19 questions with 5 or 6 possible answers per question, scored respectively from 1 to 5 and from 0 To evaluate, in women with non-metallic breast cancer followed in the Fertility Observatory at the Jeanne de Flandre Hospital, 1-year sexual health progression from chemotherapy initiation to sexual health assessment prior to cancer diagnosis announcement.
次要结局
- evolution of quality of life and psychometric factors at 1 year from the start of chemotherapy compared to the evaluation of these factors before the cancer diagnosis is announced.(At inclusion, at 1 year and 2 years after chemotherapy)
- testimony of patients expressing their experience of follow-up in the Fertility Observatory(At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,)
- association between psychometric factors assessed prior to cancer diagnosis and sexual health progression at 1 year of chemotherapy initiation(At inclusion, at 1 year and 2 years after chemotherapy)
- correlation between quality of life and psychometric factors and the assessment of sexual health of patients measured at all times.(At inclusion, at 1 year and 2 years after chemotherapy)
- describe partners' sexual health by MSHQ (man)/FSFI (woman) during follow-up(At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,)
- describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up(At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,)