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

Xiaodan Tang; Helen Huang; John D. Peipert; Anne Zola; Joseph Buscema; Kathleen Yang; William Tew; Roisin E. O'Cearbhaill; Carolyn Muller; Michael J. Goodheart; Richard G. Moore; Rebecca Liu; Melissa A. Geller; Chad Michener; John Chan; Michael Carney; Leah McNally; Daron Street; Michael A. Bookman; Kathleen N. Moore; Joyce F. Liu; Lari Wenzel; David Cella

doi:10.1016/j.ygyno.2026.05.032

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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

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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

Xiaodan Tang, Helen Huang, John D. Peipert, Anne Zola, Joseph Buscema, Kathleen Yang, William Tew, Roisin E. O'Cearbhaill, Carolyn Muller, Michael J. Goodheart, …

Gynecologic oncology, Vol.210, pp.174-182

06/08/2026

DOI: 10.1016/j.ygyno.2026.05.032

PMCID: PMC13292062

PMID: 42258989

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Abstract

Patient-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. Data 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. The 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). The 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. •The NCCN/FACT Ovarian Symptom Index-18 measures disease symptoms, side effect bother, and well-being in ovarian cancer.•NRG Oncology trial GY004 provided data to assess reliability and validity of NFOSI-18 in advanced ovarian cancer.•NFOSI-18 was found to be reliable, valid, and responsive to change, ready for use in future clinical research.•Meaningful individual change scores were found to be 4–12 points for the total score and 3–8 points for the symptom score.

Clinical Trials

Ovarian Cancer

Quality of Life

DRS-P

NFOSI-18

Patient-reported outcomes

Psychometric validation

Details

Title: Subtitle: 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
Creators: Xiaodan Tang - Northwestern University
Helen Huang - NRG Oncology
John D. Peipert - University of Birmingham
Anne Zola - Northwestern University
Joseph Buscema - Willamette Valley Cancer Institute and Research Center
Kathleen Yang - Willamette Valley Cancer Institute and Research Center
William Tew - Memorial Sloan Kettering Cancer Center
Roisin E. O'Cearbhaill - Memorial Sloan Kettering Cancer Center
Carolyn Muller - New Mexico Cancer Center
Michael J. Goodheart - University of Iowa Hospitals and Clinics
Richard G. Moore - University of Rochester Medical Center
Rebecca Liu - Trinity Health
Melissa A. Geller - Minnesota Department of Health
Chad Michener - Cleveland Clinic
John Chan - California Pacific Medical Center
Michael Carney - University of Hawaii System
Leah McNally - Duke University
Daron Street - Oklahoma Cancer Specialists and Research Institute
Michael A. Bookman - Kaiser Permanente
Kathleen N. Moore - University of Nebraska Medical Center
Joyce F. Liu - Dana-Farber Cancer Institute
Lari Wenzel - University of California, Irvine
David Cella - Northwestern University
Resource Type: Journal article
Publication Details: Gynecologic oncology, Vol.210, pp.174-182
DOI: 10.1016/j.ygyno.2026.05.032
PMID: 42258989
PMCID: PMC13292062
NLM abbreviation: Gynecol Oncol
ISSN: 0090-8258
eISSN: 1095-6859
Publisher: Elsevier Inc
Number of pages: 9
Grant note: Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) National Cancer Institute: U10CA180822 National Institute of Health: U10CA180822 NRG Operations: U10CA180868 NCORP: UG1CA189867
This study was supported in part by funding from the Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) awarded by the National Cancer Institute. (Project title: Disease-related Symptom Scale Validation in Recurrent Ovarian Cancer Phase III Studies GY004).This study was supported by National Institute of Health grants to NRG Oncology SDMC (U10CA180822), NRG Operations (U10CA180868) and NCORP(UG1CA189867).
Language: English
Date published: 06/08/2026
Academic Unit: Obstetrics and Gynecology
Record Identifier: 9985174709102771

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