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Ensuring relevance and equity in patient reported outcomes (PROs) in endometrial cancer: The SGO promote study
Lari Wenzel1, Chelsea McKinney1, Sally Jensen2
1Department of Medicine, University of California, Irvine, Irvine, CA, United States of America.
Objectives:
The Society of Gynecologic Oncology (SGO) PROMOTE Study examined the content relevance of the FACT-Endometrial (FACT-En) measure to develop an updated measure that reflects priority symptoms/concerns among diverse endometrial cancer survivors.
Methods:
Endometrial cancer patients diagnosed within the past 3 years were recruited through multiple platforms. Concept elicitation was conducted to identify priority symptoms/concerns to generate a symptom index, FACT-Endometrial Symptom Index (FEnSI). Participants listed 10 symptoms/concerns they considered most important during their cancer treatment, then rated the importance of each symptom/concern. Cognitive debriefing interviews assessed whether survey items were understood. Online surveys were administered and psychometric analyses were conducted to assess reliability and validity.
Results:
Participants (16 White/Other; 15 Black) reported 49 symptoms/concerns along with a 0-10 importance rating. Responses from 66 participants (65 % White/other; 35 % Black) produced the following scales: Disease Related Symptoms - Physical (DRSP, 8 items) (Crohnbach's alpha 0.78); Disease Related Symptoms - Emotional (DRS-E, 2 items) (0.46); Function/Wellbeing (F/WB, 4 items) (0.73); and Treatment Side Effects (TSE, 9 items, unscored). A Total index score was generated by summing responses to all 23 items. The scales demonstrated construct validity by distinguishing between clinical groups known to differ; the DRSP, F/WB, and Total scores significantly differed across ECOG Performance Status categories (p < 0.05), with large effect sizes (Cohen's d > 0.80). Construct validity was demonstrated with moderate to large (>0.371) correlations with scales from the FACT-En.
Conclusion:
The FEnSI is a clinically meaningful patient-reported symptom index reflecting the symptoms/concerns identified as most important by diverse patients with endometrial cancer.
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