Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Sexual satisfaction
研究概览
简要总结
The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.
详细描述
The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand.
All included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions".
Oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Women ≥ 18 years (menopausal or not),
- •Localized breast cancer with or without lymph node involvement,
- •Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),
- •Patient affiliated or benefiting from the social security system,
- •Patient informed and informed consent signed.
排除标准
- •History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,
- •Pregnant or breast-feeding women,
- •Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,
- •Patients unable to comply with the study schedule for social, medical or psychological reasons.
研究组 & 干预措施
Breast cancer treatment with oncosexology supporting care
Patient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care.
干预措施: Early and systematic oncosexological supporting care (Other)
结局指标
主要结局
Sexual satisfaction
时间窗: Measured at baseline and at 18 months following initiation of treatment and surgical.
Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).
次要结局
未报告次要终点