Sensitivity of the PROMIS-10 for Capturing Radiation-Related Quality of Life Changes

Abstract

Patient reported outcomes (PROs) are becoming more common when assessing the effects of radiotherapy (RT). The aim of this study was to assess the sensitivity of the Mental and Physical domains of the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) to radiotherapy and determine what predictors were associated with change in quality of life. Patients, regardless of cancer type, were enrolled on a multi-site prospective registry. Inclusion criteria included curative radiotherapy and completion of the PROMIS-10 prior to treatment (Baseline) and at End of Treatment (EOT). To assess the strongest predictors of change in the T score of mental and physical health, we included 14 demographic characteristics and treatment variables in a multivariable stepwise regression. A total of 7,586 patients were eligible for the analysis. The median age was 65 (range 18-94), 54% were males, and 94% were white. A majority received photons (62.5%) and the others received protons (37.5%) with an average dose of 52.3 Gy (range 20-80 Gy) over an average of 22.6 fractions (range 1-66). Patient disease sites were sub-grouped into 12 categories: Breast (25.5%), GU (23.0%), H&N (11.1%), CNS (8.5%), Pancreas-Biliary (6.7%), Thoracic (5.7%), Soft Tissue/Bone (5.0%), Esophagus-Gastric (4.7%), Colorectal-Anus (4.4%), Heme/Lymph (2.6%), GYN (1.8%), and Skin/Melanoma (1.0%). For both outcomes, the model selected disease group as an important predictor and it explained the most variance in the outcome compared to the rest of the predictors. When probing the effect of disease group, H&N, Esophagus-Gastric, Skin/Melanoma, and Colorectal-Anus had the largest mean decrease in quality of life for both domains. For mental health, the model also selected radiation type. Patients treated with protons indicated a bigger decrease in mental health compared to patients treated with photons (b = 0.43, 95% CI: -0.01, 0.69). For physical health, the model selected total fractions, ethnicity, and T stage. As number of fractions increased, the physical health change scores became more negative, on average (b = -0.03, 95% CI: -0.05, -0.01). Hispanic/Latino patients indicated a smaller decrease in physical health compared to White (b = -1.50, 95% CI: -2.60, -0.40) and Unknown ethnicity patients (b = -1.82, 95% CI: -3.36, -0.27). Finally, patients with a T stage of 3 or greater indicated a smaller decrease in physical health than patients with a T stage less than 3 (b = 0.76, 95% CI: 0.35, 1.16). The PROMIS-10 did not capture significant change for patients undergoing curative radiotherapy except for patients with Head & Neck, Esophagus-Gastric, Skin, and Colorectal-Anus cancer. Further analyses should explore which patients experience the greatest change in quality of life within disease group.