Determining the Minimal Clinically Important Difference of the FACT-E to Evaluate the Change in the Quality of Life of Patients with Esophageal Cancer Treated with Curative Radiotherapy

Abstract

Patients with esophageal cancer (EC) are often treated with radiotherapy (RT). The Functional Assessment of Cancer Therapy-Esophageal (FACT-E) is a health-related quality of life (QOL) instrument validated in patients with EC. The aim of this study was to determine the minimal clinically important difference (MCID) for FACT-E subscales, to allow for meaningful evaluation of the effect of RT on EC patient's QOL. We evaluated patients with EC, treated with curative intent RT, who completed the FACT-E at baseline and end of treatment (EOT). We calculated the MCID for the FACT-E subscales using anchor-based and distribution-based approaches. In the anchor-based approach we determined improvement and deterioration based on the overall health assessment from the PROMIS-10 as the anchor. We modeled the change in domain scores with age-adjusted regressions to determine the difference in classifications. For distribution-based analysis, we considered 0.3 and 0.5 standard deviation (SD). We averaged MCID for improvement and deterioration separately across timepoints, by approach, and we report MCID ranges as the minimum and maximum values across methods. Our cohort included 210 patients with EC, 96.7% white, 85.7% males, and 32.9% treated with photon with a median dose of 50 Gy (IQR 50-50) and a median fraction number of 25(IQR 25,25). The median age at RT was 67.6 years (IQR 60.9,73.7). The social domain had the lowest MCID (deterioration and improvement 0.9-1.9), while the widest MCID range, proportionally to the measure, was associated with the Fact-E total score (2.1-5.6 for improvement, and 3.7-5.6 for deterioration). MCID estimates from 0.3 SD were in exact agreement with the anchor-based deterioration estimates for the physical domain (2.3), and improvement estimates for the Trial Outcome Index (6.1). We determined the MCID for the FACT-E domains, using a combination of anchor- and distribution-based approaches. These findings are critical to determine whether there is meaningful change in the QOL of individuals with EC treated with curative RT.