Electronic Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported superior symptom control of electronic patient-reported outcome (ePRO)-based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, -0.86 [95% CI, -1.32 to -0.39]) and affective interference (estimate, -0.70 [95% CI, -1.14 to -0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.

FIG 1.

Composite functional interference score over time. Mean scores of the (A) composite physical interference and (B) composite affective interference from 1 to 12 months postdischarge measured using the MDASI-LC. Low scores indicate lower symptom burden or better functioning. Error bars are the 95% confidence intervals. ePRO, electronic patient-reported outcome; MDASI-LC, MD Anderson Symptom Inventory-Lung Cancer module.

FIG 2.

Single symptom and functional item score over time. Mean scores of (A) fatigue, (B) distress, (C) lack of appetite, (D) work, (E) enjoyment of life, (F) walking, (G) general activity, (H) mood, and (I) relations with others from 1 to 12 months postdischarge measured using the MDASI-LC. Low scores indicate lower symptom burden or better functioning. Error bars are the 95% confidence intervals. ePRO, electronic patient-reported outcome; MDASI-LC, MD Anderson Symptom Inventory-Lung Cancer module.

FIG A1.

CONSORT diagram. ePRO, electronic patient-reported outcome.