Updating the EORTC Quality-of-Life Questionnaire for Ovarian Cancer (QLQ-OV38)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHelios University Hospital Wuppertal

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

cognitive impairment

Trial population

Ovarian cancer patients from collaborating centers

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Questionnaire

Questionnaire for the quality of life of ovarian cancer patients. Patients are advised to indicate on a 4-point-Likert scale (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) how much a specific issue has occured within a specific time frame and how much this had had an impact on them. Higher scored meaning more impact on quality of life.

Time frame
Last week or last four weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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