Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial

Abstract

Introduction Non-small cell lung cancer (NSCLC) survivors suffer from impaired physical and psychological functioning and reduced health-related quality of life (HRQoL) that persist after active treatment ends. Sustaining rehabilitation benefits, promoting a healthy lifestyle and facilitating self-management at home require a multifaceted aftercare programme. We aim to investigate the effect of a 12-week digital lifestyle intervention on HRQoL and lifestyle-related outcomes in NSCLC survivors after completion of inpatient rehabilitation. Methods and analysis QUAlity of life in LUng CAncer Survivors (QUALUCA) is a multicentre randomised controlled trial that follows a hybrid type 1 design. We randomly allocate participants in a 1:1 ratio to the intervention group (digital lifestyle intervention) or the control group (standard care) using block randomisation stratified by tumour stage and study site. Four accredited Swiss inpatient rehabilitation centres recruit participants. Key inclusion criteria are a diagnosis of NSCLC, an estimated life expectancy of ≥6 months and access to a smartphone or tablet. The 12-week intervention comprises physical activity, nutrition and breathing/relaxation, delivered through a mobile application (app). The primary outcome is the change in HRQoL from baseline (1 week after rehabilitation) to follow-up (3 months after baseline), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Secondary outcomes include body mass index, self-reported physical activity, exercise capacity, risk of low protein intake, appetite, psychological distress, cancer-related fatigue, enablement and self-rated health. Explanatory outcomes in the intervention group include app usability, acceptability, appropriateness, and feasibility of the intervention, experiences and satisfaction with the intervention, and app usage data. We aim to enrol 88 participants. For the main statistical analysis, we will use analysis of covariance, adjusted for baseline measures, stratification variables, age and sex. Ethics and dissemination The Ethics Committees of the Canton of Zurich (lead), the Canton of Bern and Northwest and Central Switzerland approved the study (2023-00245). We will disseminate study results to researchers, health professionals, study participants and relevant organisations, and through publications in international peer-reviewed journals. Trial registration number NCT05819346 .