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

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT06037213
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-08-23
• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire	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	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)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China