Validation of Sexual Function Scale in Female Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 1,130
- 试验地点
- 1
- 主要终点
- sexuality
研究概览
简要总结
To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.
详细描述
Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.
The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women
- •Female without history of cancer
- •Cancer free as of the most recent linkage
- •At least 18 years of age
- •Able to speak and read Korean
- •Sexual activity within 3months.
- •Female cancer patient
- •History of gynecological or breast cancer
- •At least 18 years of age
- •Able to speak and read Korean
- •Sexual activity within 3months.
排除标准
- •Women who are unable to complete the questionnaires.
- •Refuse to participate in the survey.
结局指标
主要结局
sexuality
时间窗: 2-4 weeks
次要结局
未报告次要终点
研究者
Sang-Yoon Park
Senior researcher
National Cancer Center, Korea