Abstract

Abstract Purpose/Objective(s): Symptom burden in the advanced cancer patient can be substantial. PROMIS (Patient Reported Outcome Measurement Information System) is a powerful PRO symptom assessment tool that is increasingly being utilized at the point of care through patient-facing electronic health record (EHR) systems. However, the PROMIS threshold (T-score) for detecting severe anxiety has not been previously validated for patients with advanced breast cancer. The sensitivity/specificity of current expert derive threshold T-score of >/=75 in this specific population is not known. In this study, we compared PROMIS scores with the PRO-CTCAE anxiety instrument—a standard PRO tool used in the setting of clinical trials that assesses anxiety frequency, severity, and interference with usual activities—to examine the best T-score to use for PROMIS to guide management in advanced breast cancer care. Materials/Methods: A total of 84 unique visits of 74 English speaking patients on active cancer treatment for metastatic breast cancer were assessed using electronic PROMIS CAT (Computer Adaptive Test) and PRO-CTCAE at the UCSF Carol Buck Breast Cancer Center. Assessment forms were displayed on a touch screen tablet and completed by the patient at check-in for weekly treatment visits. PRO-CTCAE anxiety questions were graded on a scale of 1 (none) to 5 (disabling). Any score of grade >/=4 (severe to disabling) for frequency, severity or interference was defined as severe anxiety. Results: There was a strong correlation of PROMIS T-score and maximum PRO-CTCAE grade (highest grade of frequency, severity, or interference); Spearman correlation coefficient = 0.77 (P= <0.001). No patients reached the expert derived severe threshold of PROMIS T-score 75. Highest PROMIS T-score was 69 (range, 33-69). 11 patients reported severe or disabling anxiety by PRO-CTCAE at one visit. Area under the ROC analysis identified a cutoff that maximizes Youden's index at 55.05—sensitivity = 100% (95% CI) and specificity = 63% (95% CI). Conclusion: Electronic systems with integrated patient reported outcomes (PROs) along with validated thresholds to identify severe anxiety will allow for systematic identification of symptoms at point of care and the opportunity to respond rapidly to those symptoms most distressing to patients. Citation Format: Marquez C, Li Y, Huang C-Y, Rugo H, Rabow M, Melisko M, Esserman L. Measuring severe anxiety in patients with metastatic breast cancer: Living up to the PROMIS [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-18.

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