Impact of a Reminder App on Physical Activity During Radiation Therapy for Lung Cancer

Sponsor
University Hospital Schleswig-Holstein
Study ID
NCT07627022
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mobile application (reminder app) — DEVICE
    Mobile application (reminder app) that reminds patients three to four times daily to walk a pre-defined number of steps.
  • Standard radiotherapy — RADIATION
    Patients receive standard radiotherapy or radio-chemotherapy for lung cancer.

Study Details

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.

Key Dates

First listed
Jun 4, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Feb 15, 2027
Completion
Feb 15, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Standard treatment supported by a reminder app (Arm A)
    The patients receive radiotherapy or radio-chemotherapy for locally advanced lung cancer. They will be reminded by an app three to four times a day to perform a pre-defined number of steps. The patients are asked at the end of each day to confirm whether or not they reached the required number of steps.
  • Active Comparator: Standard treatment without a reminder app (Arm B)
    The patients receive radiotherapy or radio-chemotherapy for locally advanced lung cancer. They will not be reminded by an app to perform a pre-defined number of steps. The patients are asked at the end of each day to confirm whether or not they reached the required number of steps.

Primary Outcome Measure

Mean number of steps per week during week 1 and week 5 of radiation therapy for lung cancer [ Time Frame: through study completion, 5 weeks ]

Central Contacts

  • Dirk Rades, Prof. Dr.
    0049-451-500
    [email protected]
  • Maria K Streubel, Dr. rer.nat.
    0049.451-500

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