Remote symptom monitoring with patient-reported outcomes and nudges during lung cancer immunotherapy in China (PRO-NET): protocol for a randomised controlled trial.

Abstract

Introduction: Lung cancer is the leading cause of cancer-related mortality globally, with non-small cell lung cancer (NSCLC) comprising the majority of cases. For advanced NSCLC, immunotherapy offers substantial survival benefits but is often accompanied by severe immune-related adverse events symptoms, significantly affecting health-related quality of life (HRQoL). Routinely collection of patient-reported outcomes (PROs) followed by automated alerts has been shown to improve overall survival and HRQoL for cancers. However, there is limited evidence for PRO-based symptom monitoring on advanced NSCLC during immunotherapy. This study proposes an electronic PRO-based symptom tracking intervention, integrated with reactive alerts and nudges (PRO-NET) to improve HRQoL for advanced NSCLC patients receiving immunotherapy in China. Secondary objectives include assessing the effect of PRO-symptom monitoring on survival, physical function, symptom control, mental health, cost-effectiveness and implementation fidelity.

Methods and analysis: The PRO-NET study is a two-arm, parallel randomised controlled trial. The study will enrol at least 300 advanced NSCLC patients undergoing immunotherapy in China. Participants will be randomly assigned to either the intervention or control group in a ratio of 1:1 via PRO-NET programme. The intervention involves weekly electronic collection of immune-related PROs and reactive alerts sent directly to patients, combined with nudges over a 6-month period. Patients in the control group will follow usual care and will not trigger the alerts. Both the intervention and control groups will receive outcome assessments at baseline, 3 months and 6 months. Primary outcome focuses on HRQoL, while secondary outcomes include survival, physical function, symptom burden, mental health, cost-effectiveness and implementation fidelity. Differences in HRQoL between the groups will be compared using general linear mixed model, accounting for potential confounding.

Ethics and dissemination: The study was approved by the Institutional Review Board of the Peking University protocol on 21 July 2024 (No. IRB 00001052-24066). This protocol is based on V2.0, 6 July 2024 of the protocol. The results of this study will be disseminated through peer-reviewed publications and academic conferences.

Trials registration number: ChiCTR2400088408.