Quality of life between home-based and outpatient pulmonary rehabilitation in patients after surgical resection for lung cancer: protocol for a prospective, single-blind, randomised controlled trial

Abstract

Introduction: Lung cancer remains a highly fatal disease. Surgical resection has been proven to be the most effective treatment for early-stage lung cancer. The conventional hospital-based pulmonary rehabilitation (PR) is shown to reduce symptoms, improve exercise capacity and impact the quality of life (QoL) for lung cancer patients. To date, scientific evidence on the effectiveness of home-based PR for patients with lung cancer following surgery is scarce. We aim to explore if home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection.

Methods and analysis: This study is a two-arm, parallel-group, assessor-blind, single-centre, randomised controlled trial. Participants will be recruited from West China Hospital, Sichuan University and randomly allocated to either an outpatient group or a home-based group at a ratio of 1:1. The PR programme involves self-management and exercises. The exercise includes warm-up (10 min), aerobic training (20 min), resistance training (15 min) and cool-down (10 min), lasting 4 weeks, with two sessions per week either at home or in the outpatient setting. The intensity will be adjusted according to the modified Borg rating of perceived exertion and heart rate before and after each exercise session. The primary outcome is QoL measured by EORTC QLQ-C30 & LC 13 after an intervention. Secondary outcomes include physical fitness measured by a 6 min walk test and stair-climbing test and symptom severity measured by patient-reported questionnaires and pulmonary function. The main hypothesis is that home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection.

Ethics and dissemination: The trial has been approved by the Ethical Committee of West China Hospital and is also registered with the Chinese Clinical Trial Registry. The results of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Trial registration number: ChiCTR2100053714.

Keywords: Rehabilitation medicine; Respiratory tract tumours; THORACIC MEDICINE.

Figure 1

Consolidate Standards of Reporting Trials (CONSORT) flow diagram of trial design. EORTC QLQ-C30&LC13, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30/LC13; 6MWT, 6 min Walk Test; PR, pulmonary rehabilitation.