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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Quality of Life. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Questionnaire [Time frame: Last week or last four weeks]
Eligibility criteria
Inclusion criteria
- Evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV)
- Must be able and willing to complete the questionnaires.
- Must be able to understand and speak the language in which the patient will complete the questionnaire.
- Age > 18 years
Exclusion criteria
- cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Helios University Clinic Wuppertal, University Witten/Herdecke — Wuppertal
Identifiers
NCT: NCT07465133 · OV28 Phase III