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NCT07465133
Updating the EORTC Quality-of-Life Questionnaire for Ovarian Cancer (QLQ-OV38)
Conditions: Ovarian Cancer, Quality of Life
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Helios University Hospital Wuppertal
Location: Helios University Clinic Wuppertal, University Witten/Herdecke Wuppertal North Rhine-Westphalia
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.
Eligibility Criteria
Inclusion Criteria:
1. Evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV)
2. Must be able and willing to complete the questionnaires.
3. Must be able to understand and speak the language in which the patient will complete the questionnaire.
4. Age \> 18 years
Exclusion Criteria:
* cognitive impairment
Source: ClinicalTrials.gov (NCT07465133). StuddyBuddy aggregates publicly available trial information.