Examınatıon of Sexual Functıon in Young Women After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Sexual function
研究概览
简要总结
The aim of this observational study was to analyse sexual function in young women after breast cancer surgery. The main question it aims to answer is Sexual function in young women after breast cancer surgery changes during the one-year follow-up period. Participants will answer demographic information, Female Sexual Function Scale, Breast-Q and Body Perception Scale about their sexual function, quality of life and body perception. These will be recorded before surgery and repeated 6 weeks, 6 months and 1 year after surgery.
详细描述
As a result of the power analysis of the preliminary study conducted with the participation of 9 cases; it was calculated that 80% power could be obtained at 95% confidence level when at least 47 people were included in the study. However, considering that the results of the preliminary study will not be conclusive, it is planned to complete the study with at least 52 people by taking 10% more participants. The data will be analysed with SPSS 25.0 package programme. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. Repeated measures ANOVA test, Kruskal-Wallis test or Friedman test will be used according to the parametric test assumptions.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals scheduled for surgery for breast cancer
- •Accepting to participate in the study
- •Being sexually active in the last 1 year
- •Continuation of menstruation
排除标准
- •Previous breast cancer surgery
- •Previous history of breast cancer
- •History of any other cancer
- •Refusal to participate in the study
- •Refusal to continue working
- •Problems in her relationship with her partner
研究组 & 干预措施
Young women with breast cancer
Sexually active young women scheduled for breast cancer surgery
干预措施: No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery (Other)
结局指标
主要结局
Sexual function
时间窗: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
In this study, it is planned to follow up the patients from the early postoperative period in order to emphasise and draw attention to the difficulties experienced by individuals with breast cancer in their sexual life. Female sexual function will evaluate with a detailed 19-item likert-type questionnaire \[Female Sexual Function Index (FSFI)\] described by Rosen et al. Questions 1 and 2 are scored between 1-5, questions 3-13 are scored between 0-5, questions 14-16 are scored between 0 and 1-5 and questions 17-19 are scored between 0-5. Accordingly, the highest raw score to be obtained from the scale is 95 and the lowest raw score is 4. The cut-off score of the scale is determined as 26.55 and it is stated that women who score below this score have sexual dysfunction (Aydemir and Güneş 2024). High scores on the scale indicate that sexual function is good. The Turkish validity and reliability study of the scale was conducted by Aygin and Aslan in 2005.
次要结局
- Quality of life of participants(It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.)
- Participants' body perception(It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.)
研究者
ATİYE KAŞ ÖZDEMİR
Principal Investigator
Pamukkale University