Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Sexual well-being
研究概览
简要总结
The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys.
This data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments.
Specific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy).
Our goal is to improve quality of life of breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Patients undergoing mastectomy for primary breast cancer;
- •High-risk healthy patients undergoing risk reducing mastectomies;
- •Unilateral and/or bilateral mastectomies;
- •If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast;
- •All reconstructive procedures included (autologous and heterologous reconstructions).
排除标准
- •Patients undergoing breast conservation;
- •Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers;
- •Delayed post-mastectomy reconstructions;
- •Patients not available for e-correspondence.
研究组 & 干预措施
Survey
At 1-year follow-up, breast cancer patients who underwent mastectomy and reconstruction are asked to complete several questionnaires after the medical consultation collecting sociodemographic information and their sexual well-being.
干预措施: Survey using a questionnaire. (Other)
结局指标
主要结局
Sexual well-being
时间窗: Enrollment visit
Sexual well-being, a multidimensional construct, will be assessed using a combination of validated and non-validated questionnaires. For each outcome score, descriptive statistics will be reported, including mean, standard deviation, median, and interquartile range. Comparisons of mean scores across predefined subgroups-such as type of reconstruction, systemic and local treatments, menopausal status, obesity, and parity-will be conducted using analysis of variance. A p-value \< 0.05 will be considered statistically significant.
次要结局
未报告次要终点