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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06037213

Collaborator

(none)

500

Enrollment

Location

5.3

Anticipated Duration (Months)

94.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 23, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Outcome Measures

Primary Outcome Measures

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)
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).

Other Outcome Measures

Patient population checklist [at baseline]
Baseline characteristics, disease history, comorbidities and concomitant treatments, education.
Niraparib medication checklist [at baseline]
Starting dose, dose modification.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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