Update of the EORTC QLQ-Ovarian Cancer Module (EORTC-QLQ-OV28) phase I and II.

Abstract

5596 Background: Ovarian cancer is the eighth most common cancer in women worldwide. The 5-year survival rate is 90.0% for early-stage disease and 30.2% for advanced disease. The introduction of new treatment options, such as PARP inhibitors, immunotherapy and bevacizumab, has led to improved recurrence-free intervals and an increased number of long-term survivors. However, new therapies have also brought new side effects that are not sufficiently covered by the EORTC QLQ OV-28, which was developed in 1997. There is therefore a strong clinical and research need to update the questionnaire to reflect contemporary treatments and their impact on QoL. This work presents the results of Phases 1 and 2 of the EORTC module development study updating the EORTC QLQ-OV28. Methods: The EORTC QLQ-OV28 module was adapted in accordance with the EORTC QLG guidelines for methodology for updating modules focused on identifying QoL issues relevant to ovarian cancer patients. This involved a systematic literature search, a review of questionnaires , investigator brochures, focus groups, and research group meetings (Phase 1).An issue was added to the list if it had a patient and/or HCP relevance rating of at least 2 (on a scale of 1 to 4) and a priority rating of at least 30%. The relevant issues were then translated into items, resulting in a preliminary questionnaire (Phase 2). Results: The mixed methods approach identified 57 issues related to QoL in ovarian cancer patients. An issue list was created and used for interviews with 58 patients and 31 HCPs, who rated each issue according to its relevance using a four-point response format: 'not at all', 'a little', 'quite a bit', 'very much' and priority (yes/no). Of the initial 57 issues, 20 (as rated by patients) and 34 (as rated by HCPs) met both inclusion criteria. Sixteen of these were covered by the existing EORTC QLQ-OV28, and five new issues were identified: weight loss, numbness in the hands and feet, anxiety, concerns about acceptance of their condition, and impaired sexuality. Twelve issues from the existing questionnaire did not fulfil all the inclusion criteria.In Phase II, these issues were translated into items and used to create a preliminary 39-item questionnaire to assess QoL in ovarian cancer patients. Conclusions: The results of Phases I and II indicate that the current EORTC QLQ-OV28 module does not adequately address all the relevant QoL issues for patients with ovarian cancer. Five new issues are not addressed by the existing module, and twelve existing issues did not fulfil all the inclusion criteria. Therefore, the EORTC QLQ-OV28 module should be updated. A preliminary questionnaire will be tested in Phase III of the EORTC module development process. Note: This document represents preliminary findings of the module development and is subject to revision; subsequent modifications of the module in the next stages may reflect significant changes.