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

NCT07627022 | Not Yet Recruiting

• 1 other identifier: APPAREL
• Study Type: interventional
• Target: 32
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Lung Cancer

Keywords

Lung cancer; Radiotherapy; Physical activity; Step counts; Reminder app

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, 5 weeks

Secondary Outcomes (2)

• Rate of patient satisfaction with the reminder app

  through study completion, 5 weeks

• Degree of the impact of the reminder app

  through study completion, 5 weeks

Study Arms (2)

Standard treatment supported by a reminder app (Arm A)

EXPERIMENTAL

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.

Device: mobile application (reminder app); Radiation: Standard radiotherapy

Standard treatment without a reminder app (Arm B)

ACTIVE COMPARATOR

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.

Radiation: Standard radiotherapy

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 treatment supported by a reminder app (Arm A)

Standard radiotherapy RADIATION

Patients receive standard radiotherapy or radio-chemotherapy for lung cancer.

Standard treatment supported by a reminder app (Arm A); Standard treatment without a reminder app (Arm B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent
• Capacity of the patient to consent

You may not qualify if:

• \. Expected non-compliance

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• European Regional Development Fund: collaborator

Study Sites (7)

Department of Oncology Vejle Hospital, University Hospital of Southern Denmark

Vejle, 7100, Denmark

Location

Radiation Oncology Department, Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, 0177, Georgia

Location

MVZ RON Niedersachsen Strahlentherapie GmbH

Hanover, Lower Saxony, 30161, Germany

Location

Department of Radiation Oncology, Christian-Albrechts University

Kiel, Schleswig-Holstein, 24105, Germany

Location

Department of Pulmonology, University of Luebeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Department of Radiation Oncology, University of Luebeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Department of Radiotherapy, Institute of Oncology Ljubljana and Faculty of Medicine, University of Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Dirk Rades, Prof. Dr.

  Department of Radiation Oncology, University of Luebeck, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof. Dr.

CONTACT

0049-451-500; Dirk.Rades@uksh.de

Maria K Streubel, Dr. rer.nat.

CONTACT

0049.451-500

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center prospective randomized study. Patients will be randomized in a 1:1 ratio to receive either standard radiation therapy supported by a reminder application or standard radiation therapy without additional support.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); DK (1); GE (1); DE (4)