NCT07465133

An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer - Phase III

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Helios University Hospital Wuppertal · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to pre-test the EORTC QLQ-OV39 to identify and resolve potential problems in its administration and to identify missing/redundant items. A preliminary evaluation of the measurement properties of the module will be carried out. The study includes patients with evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV) above the age of 18 years. The main aims are: 1. To conduct Phase 3a and 3b pre-testing of the preliminary EORTC-QLQ-OV39 Questionnaire to identify and resolve potential problems in its administration and to identify missing/redundant items according to the updated EORTC QLG Guidelines for Module Development, 5th Edition 2021.(16) 2. a preliminary assessment of the psychometric properties of the module Participants will \[describe the main tasks participants will be asked to, complete the OV39, C30 and debriefing interviews, as well as questions about their demographics and clinical data.

Detailed description

Follows.

Conditions

• Ovarian Cancer
• Quality of Life

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Germany