Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Post-Traumatic Stress Disorder evaluation
研究概览
简要总结
This is a multicenter, prospective study aimed at providing information on the psychological effects (including post-traumatic stress symptoms) of utero-vaginal brachytherapy in patients with cervical cancer using self-administered questionnaires. The study also aims to assess the persistence of these symptoms over time, up to 5 years after brachytherapy. The results could help identify patients at risk of post-traumatic stress in this context and develop appropriate psychological interventions to improve their psychological well-being during and after treatment.
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
- •Confirmed diagnosis of cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy;
- •Squamous cell carcinoma or other histological types;
- •Ability to complete validated questionnaires in French;
- •Informed consent to participate in the study;
- •Patients over 18 years old
排除标准
- •Inability to understand or respond to questionnaires due to a cognitive disorder, intellectual disability, language barrier, or psychiatric disorder that impairs judgment;
- •Patient under juridic protection;
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Patient with cervical cancer with an indication for uterovaginal brachytherapy
干预措施: Prospective questionnaires (Other)
结局指标
主要结局
Post-Traumatic Stress Disorder evaluation
时间窗: at 2 months
Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32
次要结局
- Anxiety and Depression(until 60 months)
- Quality of Life (general module)(until 60 months)
- Quality of Life (cervical cancer module)(until 60 months)
- Sexual Health evaluation(until 60 months)