Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire
研究概览
简要总结
This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire.
The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.
详细描述
The original version of the questionnaire will be validated in two phases: a) translation, b) reliability.
- Translation of the items and administration to a small sample of volunteers to assess usability.
In the first phase, the questionnaire will be translated following the 5 steps:
- forward translation by two independent translators (from English to Italian);
- synthesis (discussion between translators to resolve any discrepancies);
- backward translation (from Italian to English) by two additional independent translators;
- expert committee (translators, psychologists, sexology consultants) comparing the two versions of the questionnaire; 5) testing the first version of the questionnaire with a sample (N=20) of native Italian speakers to evaluate the adequacy of content and clarity of terms used and proceeding to the final version.
- Reliability of the questionnaire. To assess the reliability of the questionnaire, it will be administered again after a 2-week interval to a smaller sample compared to the recruited patient sample.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Women with operable breast cancer;
- •Operated on between 2012 and 2020;
- •Randomly selected from the institutional database; 18 years of age (Age stratification: equally represented women aged <50 years and women aged ≥50 years);
- •Signing of the informed consent.
排除标准
- •Severe psychiatric or cognitive illness;
- •Ongoing psychological treatment.
结局指标
主要结局
Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire
时间窗: 12 months
The measure of internal consistency utilized is Cronbach's alpha (α). The comparison will be done between the estimated α in the Italian questionnaire and the α of the original work.
次要结局
未报告次要终点