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.