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.
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
None
Parallel
mobile application (reminder app)
DeviceMobile application (reminder app) that reminds patients three to four times daily to walk a pre-defined number of steps.
Standard radiotherapy
RadiationPatients receive standard radiotherapy or radio-chemotherapy for lung cancer.
Mean number of steps per week during week 1 and week 5 of radiation therapy for lung cancer
The primary endpoint is to assess the within-patient difference in weekly average steps per wear-hour of the smart phone (Week 5 minus Week 1 of radiation therapy). Any type of smart phone is allowed, as long as it has a step counter.
Rate of patient satisfaction with the reminder app
Patient satisfaction with the reminder app will be assessed with a specific questionnaire.
Degree of the impact of the reminder app
The impact of the reminder app on the use of health technology will be assessed with a specific questionnaire.
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University Hospital Schleswig-Holstein
Lead sponsor
European Regional Development Fund
Collaborator
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