Remote symptom-monitoring of patients with advanced lung cancer: A Danish national randomized controlled trial—The ProWide study.

1508 Background: Symptom-monitoring of patients with lung cancer has previously been shown to improve clinical outcomes. We conducted a national randomized controlled trial to evaluate the effects of remote symptom-monitoring of patients with advanced lung cancer completing induction treatment in a Danish setting. Methods: Patients with stage III-IV lung cancer treated with palliative intention, ECOG performance status ≤2, internet access and non-progressive disease after completed induction treatment were eligible. Patients were randomized 1:1 to remote symptom-monitoring (intervention arm) added to standard of care or standard of care alone (control arm). Maintenance therapy was allowed. Patients in the intervention arm weekly completed an electronic questionnaire from home covering 13 common symptoms related to lung cancer. A severity-threshold was applied to each question. When a threshold was exceeded, a notification was sent to a clinical nurse. The nurse was instructed to contact the patient and offer best supportive care. If disease progression was suspected, a computerized tomography (CT) scan was performed. Primary outcome was overall survival. Secondary endpoints included Health-related Quality of Life (HRQoL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30/LC13 and Hospital Anxiety and Depression Scale (HADS) scales. Results: Of 494 randomized patients, recruited from 8 departments, 239 were assigned to the intervention and 254 to standard of care (inclusion rate 75%). Weekly compliance to symptom-monitoring during the first year was 82% in the intention-to-monitor population. At a median follow-up of 2.6 years, no significant improvement in overall survival (OS) was found in the intervention arm compared to the control arm (hazard ratio (HR) 0.93, 95% confidence interval (CI); 0.75 to 1.16; p = 0.54). Sub-group analyses indicated improved OS for patients treated with carboplatin/vinorelbine (HR 0.65, CI 95%; 0.44-0.96, p = 0.03) and for patients treated in a department with prior implementation and use of patient-reported outcomes in clinical decision-making (HR 0.68, CI 95%; 0.46-1.01, p = 0.054). For prespecified scales in the HRQoL-analyses, no clinically meaningful effects were found. For physical functioning, mean overall change from baseline was 3.1 points (95% CI 0.1 to 6.2, p = 0.043), for pain, -3.9 points (95% CI; -8.4 to 0.7, p = 0.096) and for HADS-anxiety, -0.5 points (95% CI; -1.0 to 0.0, p = 0.070). Conclusions: Remote symptom-monitoring did not significantly improve clinical outcomes for patients with advanced lung cancer in a Danish population. The results indicated benefits for a sub-group of patients not receiving maintenance therapy and that prior organizational experiences may be a prerequisite for improving outcomes of symptom-monitoring. Clinical trial information: NCT03608410 .