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

NCT06037213 | Unknown

• 1 other identifier: PekingUMCH-PRO1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (2)

• Patient population checklist

  at baseline

• Niraparib medication checklist

  at baseline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are members of the patient assistance programme population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Yang Xiang, MD.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Peng, MD.

CONTACT

+86-13521361934; pengp1999@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: August 23, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)