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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06037213

Enrollment

500

Registered

2023-09-14

Start date

2023-08-23

Completion date

2024-01-31

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

patient-reported outcomes, niraparib, real-world, ovarian cancer, quality of life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Patient population checklist	at baseline	Baseline characteristics, disease history, comorbidities and concomitant treatments, education.
Niraparib medication checklist	at baseline	Starting dose, dose modification.

Countries

China

Contacts

Primary ContactPeng Peng, MD.

pengp1999@163.com+86-13521361934

Outcome results