Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

Abstract

Purpose: We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery.

Methods: Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted.

Results: Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert.

Conclusion: PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

FIG 1.

CONSORT diagram.

FIG 2.

Number of symptom threshold events at discharge in all hospitals, the cancer hospital, and the general hospital. The box plot shows the median (horizontal line in the box), 25th and 75th quartiles (box limits), and minimum and maximum (bars). PRO, patient-reported outcome; IQR, interquartile range. PRO-based symptom management may be the preferred patient care approach following lung cancer surgery.

FIG 3.

Symptom severity over time. (A) Composite symptom score of the target symptoms (pain, fatigue, disturbed sleep, shortness of breath, and coughing) during hospitalization. (B) Composite symptom score of the target symptoms after discharge. High scores indicate more severe symptoms. I bars represent 95% CIs. PRO, patient-reported outcome.

FIG 4.

Functional interference over time. (A) Composite physical interference score (MDASI-LC general activity, work, and walking) during hospitalization. (B) Composite physical interference score after discharge. (C) Composite affective interference score (MDASI-LC mood, relations with others, and enjoyment of life) during hospitalization. (D) Composite affective interference score after discharge. High scores indicate more severe functional interference. I bars represent 95% CIs. MDASI-LC, MD Anderson Symptom Inventory-Lung Cancer module; PRO, patient-reported outcome.