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Open Access 01-12-2024 | Lung Cancer | Study protocol

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol

Authors: Ying Liang, Pengyu Jing, Zhongping Gu, Lei Shang, Peng Ge, Yong Zhang, Lv Wang, Chun Qiu, Ximing Zhu, Zhijun Tan

Published in: Trials | Issue 1/2024

Abstract

Introduction

Lung cancer is the most common cancer in China, with the highest mortality rate. Surgery is the primary treatment for early lung cancer. However, patients with lung cancer have a heavy burden of symptoms within 3 months after surgery, which seriously affects their quality of life (QOL). The symptom management model based on the patient-reported outcome (PRO) is considered the best caregiving model. The clinical evidence about the symptom management of lung cancer within 3 months after the operation is very limited. Herein, we propose a randomized controlled trial to evaluate the PRO score-based monitoring and alert system for follow-up on psychological and physiological symptoms of lung cancer patients within 3 months after surgery and further investigate the effect of intervention measures based on this PRO score-based system.

Methods and analysis

This multicenter, open-label, randomized, parallel superiority trial will be conducted at four hospitals in China. A total of 440 lung cancer patients will be recruited in this study, who will be randomly assigned to the intervention group or the control group in a ratio of 1:1. Any of the target symptoms reaches the preset threshold (score ≥ 4), the patients will accept the symptom management advices based on the PRO. The patients in the control group will follow the current standard procedure of symptom management. The symptom management system is an electronic management system based on WeChat mini programs. All patients will be evaluated for symptoms through the lung cancer module of the MDASI lung cancer-specific scale on the day before surgery, days 1, 3, 5, and 7 after surgery, and once a week during the 12-week post-discharge period. Simultaneously, the EORTC QLQ-C30 scale will be used to evaluate patients’ quality of life at baseline and the fourth and twelfth week after the surgery. The mean number of symptom threshold events of the intervention and the control groups were compared by t-test, and the changes of PRO were compared by a mixed effect model. The primary endpoint has been set as the 12-week post-discharge period.

Discussion

This study will test the feasibility of the symptom management system based on the mobile social media applet in postoperative caregiving and the efficacy of psychiatrist-assisted treatment and provide evidence in managing the symptoms of patients in the medium and long term.

Trials registration

Trials registration number: ChiCTR 2200058876, Registered 18 April 2022

Available only for authorised users

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Title: Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol
Authors: Ying Liang
Pengyu Jing
Zhongping Gu
Lei Shang
Peng Ge
Yong Zhang
Lv Wang
Chun Qiu
Ximing Zhu
Zhijun Tan
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Lung Cancer
Lung Cancer
Lung Cancer
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-07963-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol

Abstract

Introduction

Methods and analysis

Discussion

Trials registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods and analysis

Discussion

Trials registration

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