About this trial
The primary objective of this prospective randomized trial is to explore whether the use of a smart phone-based reminder application is associated with a change in physical activity during radiation therapy in patients with lung cancer. The primary endpoint focuses on the within-patient change in physical activity between Week 1 and Week 5, with comparison between treatment groups to assess potential differences attributable to the intervention.
Secondary objectives include the exploratory assessment of patient satisfaction with the reminder app, its impact on the use and perception of digital health technology.
A total of 28 evaluable patients in the Full Analysis Set (approximately 14 per treatment arm) are required to detect a clinically relevant difference corresponding to a probability of superiority of approximately 0.65 with 80% power at a two-sided significance level of 0.05. Assuming that approximately 10% of patients will not be evaluable for the primary endpoint, a total of 32 patients will be randomized.
Eligibility criteria
Qualifiers
Histologically proven lung cancer
Treatment with ≥50 Gy of conventionally fractionated radiation therapy
Possession of and ability to use a smart phone plus a step counter
Age ≥18 years
Disqualifiers
None
Trial design
Treatments tested in this trial
- mobile application (reminder app)
- Standard radiotherapy
Treatment groups
Sponsors and collaborators
University Hospital Schleswig-Holstein
Lead sponsor
European Regional Development Fund
Collaborator