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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037213
• Other study ID #: PekingUMCH-PRO1
• Status: Recruiting
• Start date: August 23, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: Peng Peng, MD.
• Phone: +86-13521361934
• Email: pengp1999[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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