A Real-World Patient-Reported Outcomes Study in Patients With Long-Term Use of Niraparib

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-interventional Study to Collect Real-world Patient-Reported Outcomes Data in Platinum-Sensitive Relapsed Ovarian Cancer Patients With Long-Term Use of Niraparib

Conditions
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Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported health-related quality of life (HRQoL) - EQ-5D-5L questionnaire | 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) | 4 months | 
| Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire | 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). | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-reported outcomes, niraparib, real-world, ovarian cancer, quality of life