Abstract
Objective: The incorporation of patient-reported outcomes (PROs) is essential for assessing whether a cancer treatment enhances overall patient well-being, beyond merely extending survival. This scoping review aimed to identify and analyze the use of PROs in ovarian cancer clinical trials.
Methods: A comprehensive search was conducted in three databases (PubMed, CINAHL, and PsycINFO) to identify randomized controlled trials (RCTs) on ovarian cancer interventions published in peer-reviewed journals. Key study characteristics, including study design, participant demographics, and assessed outcomes, were extracted.
Results: Thirty-six studies were included in the review. The majority reported progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) as primary and secondary outcomes. Nineteen studies incorporated PROs as outcome measures. The most frequently utilized PRO instruments were the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) and the EORTC Quality of Life Questionnaire Ovarian Cancer Module (EORTC QLQ-OV28). Other PROs included the EuroQol-5Dimensions (EQ-5D), Functional Assessment of Cancer Therapy–Epidermal Growth Factor Receptor Inhibitors?18 (FACT?EGFRI?18), Functional Assessment of Cancer Therapy–Ovarian (FACT?O), and NCCN-FACT Ovarian Symptom Index-18 (FACT NFOSI-18). This review summarized the PROs used as assessment endpoints in these trials.
Conclusion: This review highlights the significant yet underutilized role of PROs in ovarian cancer clinical trials and underscores the need for ovarian cancer-specific PROs to better assess treatment impact on patient quality of life.
Keywords
Ovarian cancer, Ovarian neoplasms, Patient-reported outcome measures, Quality of life, Treatment outcome