Assessment of Physical Activity During Radiation Therapy for Lung Cancer: Study Protocol of the APART-LUNG Study

Background/Objectives: Radiation therapy is a common treatment modality for non-small-cell and small-cell lung cancer that can be associated with considerable side effects, mainly reactions of healthy tissues in the radiation field. Radiation therapy may lead to significant fatigue, which can potentially be mitigated by maintaining or increasing physical activity during treatment. Since achieving this goal may be a challenge for patients, they may benefit from a mobile application reminding them daily to perform a predefined number of steps. Such a reminder app will be investigated prospectively in a phase 2 trial. The current APART-LUNG study (NCT07380815) is a mandatory study for designing the prospective trial. Methods: The main objective of the APART-LUNG (exploratory non-interventional) study is to report patterns of physical activity during radiation therapy for lung cancer patients and generate hypotheses based on our findings. Our primary endpoint is the within-patient difference in weekly average steps per wear hour of the smartphone (week 5 minus week 1 of radiation therapy), and our secondary aim is to estimate differences in operational measures (wear time of the smartphone) between week 5 and week 1. The sample size of approximately 20 patients (full analysis set) allows us to detect a moderate-to-large standardized within-patient difference and is driven by feasibility and the intent to obtain preliminary estimates of effect size and variability. The results of the APART-LUNG study will be very important for appropriately designing a phase 2 trial.