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

NCT07465133 | Not Yet Recruiting

• 1 other identifier: OV28 Phase III
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 2.a preliminary assessment of the psychometric properties of the module

Conditions

Ovarian Cancer; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Questionnaire

  Questionnaire for the quality of life of ovarian cancer patients

  Last week or last four weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ovarian cancer patients from collaborating centers

You may qualify if:

• 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

You may not qualify if:

• cognitive impairment

Sponsors & Collaborators

• Helios University Hospital Wuppertal: lead

Study Sites (1)

Helios University Clinic Wuppertal, University Witten/Herdecke

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Vesna Bjelic-Radisic, Gynaecologist, Director of the Breast Center

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)