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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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07465133
Acronym
EORTC QOL-OV39
Enrollment
50
Registered
2026-03-11
Start date
2026-09-01
Completion date
2028-12-01
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Quality of Life

Keywords

ovarian cancer, EORTC, Quality of Life, EORTC Quality of life group

Brief 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.

Interventions

None listed

Sponsors

Helios University Hospital Wuppertal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
QuestionnaireLast week or last four weeksQuestionnaire for the quality of life of ovarian cancer patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026