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NCT07627022
Impact of a Reminder App on Physical Activity During Radiation Therapy for Lung Cancer
Conditions: Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: University Hospital Schleswig-Holstein
Location: Department of Oncology Vejle Hospital, University Hospital of Southern Denmark Vejle
Summary
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
Inclusion Criteria:
1. Histologically proven lung cancer
2. Treatment with ≥50 Gy of conventionally fractionated radiation therapy
3. Possession of and ability to use a smart phone plus a step counter
4. Age ≥18 years
5. Written informed consent
6. Capacity of the patient to consent
Exclusion Criteria:
1\. Expected non-compliance
Source: ClinicalTrials.gov (NCT07627022). StuddyBuddy aggregates publicly available trial information.