Trial reportGynecologic oncology2026
Psychometric evaluation of the NFOSI-18 disease related symptoms - Physical, NFOSI-18 Total, and FACT GP5 in the recurrent ovarian cancer phase III study GY004.
Trial report in Gynecologic oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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23 authors.
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Abstract
backgroundPatient-reported outcomes (PROs) are critical in recurrent ovarian cancer, where symptom burden and quality of life (QOL) influence treatment decisions. Given limited psychometric validation of PROs in patients receiving modern targeted therapies, we conducted a comprehensive evaluation of the NCCN/FACT Ovarian Symptom Index-18 (NFOSI-18), including both Total and disease-related symptoms (DRS-P) subscale scores, and a single-item about side effect (GP5), to assess their reliability and validity in recurrent ovarian cancer.
methodsData were drawn from NRG Oncology trial GY004 (n = 489). Participants completed the NFOSI-18, EQ-5D-3L and EQ-VAS at baseline and every 12 weeks. Baseline and last QOL time points were analyzed to evaluate psychometric properties of the NFOSI-18 DRS-P and Total scores, and the GP5 item. Analyses included internal consistency reliability, convergent and known-groups validity, responsiveness to change, and meaningful change thresholds.
resultsThe DRS-P and Total scales demonstrated good internal consistency (Cronbach's α = 0.72-0.87) and moderate convergent validity with EQ-5D VAS and Utility Index (r = 0.56-0.63). Strong known-groups validity was observed, with moderate-to-large effect sizes (0.44-1.05) across performance status categories. Score declines were greater in patients with stable or progressive disease compared to those with complete or partial response, supporting responsiveness to clinically meaningful change. Recommended change thresholds were 4-12 points (Total) and 3-8 points (DRS-P).
conclusionsThe NFOSI-18 DRS-P and Total scales are reliable, valid, and responsive measures in recurrent ovarian cancer. These findings support their use as PRO endpoints in future ovarian cancer clinical trials.
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