Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
研究概览
简要总结
In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients
详细描述
Breast cancer is the most common cancer in women. Its incidence increases with 58,459 new cases in France in 2018, however its mortality decreases with a survival rate of 87% at 5 years.
Therapeutic options are surgery, radiotherapy, chemotherapy and hormone therapy. Hormone therapy is one of the major treatments for hormone-sensitive tumors with a prescription made in around 70% of breast cancer cases. These different hormone therapies cause a hormonal imbalance with in particular an important anti-estrogenic action. Hormonal deprivation and menopause can be responsible for the occurrence of pelvic statics disorder.[5-9] Pelvic static disorder (PTS) is a common problem for women, which can occur at any age.
These disorders include urinary incontinence, stress or urgency, anal incontinence, genital prolapse.
Hypothesis's investigator is that hormone therapy may be responsible for PTS. In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with Age ≥ 50 years
- •Menopaused
- •Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy
- •Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy.
- •Patient who agreed, after receiving information, to participate to the study.
排除标准
- •Metastatic breast cancer
- •Patient with a history of pelvic static surgery
- •Patient with a history of pelvic irradiation
- •Patient unable or unwilling to complete the questionnaires
- •Patient with a history of urinary incontinence treatment
- •Patient not affiliated to the French social security system
- •Subject under tutelage, curatorship or safeguard of justice,
- •Patient in an emergency situation,
- •Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
- •Pregnant and / or breastfeeding woman.
结局指标
主要结局
Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
时间窗: Day 1
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)
次要结局
- Evaluate the correlation between hormone therapy and pelvic static disorders(Day 1)
- Research the risk factors for pelvic static disorders(Day 1)
- Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)(Day 1)
- Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +(Day 1)
- Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups(Day 1)
- Evaluate the impact of pelvic static disorders on quality of life(Day 1)