Non-interventional Study to Collect Real-world Patient-Reported Outcomes Data in Platinum-Sensitive Relapsed Ovarian Cancer Patients With Long-Term Use of Niraparib
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire
研究概览
简要总结
This prospective, non-interventional study is designed to evaluate the quality of life of Chinese ovarian cancer patients with long-term niraparib use in a real-world setting. Participants will complete questionnaires or accept telephone follow-up to provide information about their quality of life.
详细描述
In this prospective, non-interventional study, patients with platinum-sensitive relapsed ovarian cancer who have received niraparib as maintenance therapy for more than two years will agree to be contacted by questionnaire or telephone three times. The interval will be 4-6 weeks. Information on quality of life will be collected and analysed.
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
- •Age ≥18 years
- •Histologically confirmed platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
- •Maintenance treatment with niraparib for ≥2 years and continuing for the next 28 days
- •No significant cognitive impairment
- •Understand the trial procedure and be able to sign the informed consent form before any study-related procedures
排除标准
- •Patients who are not suitable for participation in this study according to the investigator's evaluation
- •Patients receiving antineoplastic drugs for other malignancies
- •Patients who are unable to comply with the protocol procedures
结局指标
主要结局
Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire
时间窗: 4 months
The FOSI (Functional Assessment of Cancer Therapy-Ovarian Symptom Index) is a validated tool with eight items that measure response to treatment based on symptom assessment. The questions assess pain, fatigue, nausea, vomiting, bloating, cramping, worry, and QoL. Patients report their symptoms over the past week using a five-point Likert scale, which ranges from 0 (not at all) to 4 (very much).
Patient-reported health-related quality of life (HRQoL) - EQ-5D-5L questionnaire
时间窗: 4 months
The EQ-5D is a standardized measure of health status applicable to a wide range of health conditions and treatments designed by the EuroQoL Group (EQ). It consists of the EQ-5D-5L descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with each dimension having 5 levels (5L), and the EQ visual analogue scale (EQ VAS)
次要结局
未报告次要终点