Physical Activity During Radiation Therapy for Lung Cancer (APART-LUNG)

Assessment of Physical Activity During Radiation Therapy for LUNG Cancer

The primary objective of this trial is to evaluate patterns of physical activity during radiation therapy for lung cancer and to estimate the within-patient change in physical activity between Week 1 and Week 5 of radiation therapy, measured by smart phone-recorded step counts normalized for device carrying time. The trial is exploratory in nature with the aim to generate scientific hypotheses to be investigated in future clinical trials.

Study Overview

• Status: Completed
• Conditions: Prospective Study

Detailed Description

Lung cancer belongs to the most common types of solid cancer in Europe and Northern America. A considerable number of patients with lung cancer receive conventionally fractionated radiation therapy with or without systemic treatment. Radiation therapy may be associated with adverse events affecting healthy tissues within the radiation field but also with fatigue and a decreased level of physical activity or function. Patients who experience significant treatment-related toxicity may not be able to receive the complete radiation therapy as planned. Maintaining or even improving the level of activity by physical exercise or walking a certain number of steps per day may be helpful in this context. A benefit of exercise has been suggested in a retrospective study of 184 cancer patients receiving neoadjuvant chemotherapy, including 31 patients with lung cancer. Adherence to an exercise program was associated with fewer dose reductions and delays of chemotherapy. Moreover, several studies performed in patients with lung cancer suggested that physical activity had a positive effect on the patient's quality of live. Thus, physical activity prior to and during chemo- and/or immunotherapy for lung cancer appears important. This may also be true for patients with lung cancer treated with radiation therapy. However, adherence to an exercise program sometimes may be challenging for the patients, particularly if they experience treatment-related fatigue or other adverse events. The question arose whether an easy-to-use mobile app installed on the patient's smart phone reminding patients several times daily to perform a certain number of steps will have a positive effect on their physical activity during a course of radiation therapy. Such an app is planned to be tested in a prospective trial. However, step counts derived from smart phones are influenced by variability in device carrying time, as patients may not carry their phones consistently throughout the day. This variability introduces measurement heterogeneity that must be explicitly addressed in the statistical design and analysis. The present study is designed as a pilot investigation for this prospective trial to evaluate changes in physical activity during radiation therapy while establishing a robust and Good Clinical Practice (GCP)-compliant analytical framework for smart phone-derived step data. Physical activity is assessed during Week 1 and Week 5 of radiation therapy using a smart phone application. A total of approximately 20 patients qualifying for the Full Analysis Set are planned to be enrolled and documented. Recruitment of all patients should be completed within 3 months. This period also represents the total running time for this study. The study is designed as a pilot and feasibility investigation and is not intended to provide confirmatory evidence.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark, 7100
    • Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark
• Georgia
  • Tbilisi, Georgia, 0177
    • Radiation Oncology Department, Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30161
      • MVZ RON Niedersachsen Strahlentherapie GmbH
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Department of Radiation Oncology, Christian-Albrechts University
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Department of Radiation Oncology, University of Luebeck
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Department of Pulmonology, University of Luebeck
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Department of Radiotherapy, Institute of Oncology Ljubljana and Faculty of Medicine, University of Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received conventionally fractionated radiation therapy for lung cancer.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with steps counted by their smart phone; The purpose is to obtain a patient's mean number of steps per week during week 1 and week 5 of a radiation therapy course for lung cancer directly from the patient's smart phone which has a step counter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wear-time of the smart phone	The mean wear-time of the smart phone per day (given in hours) during week 1 and week 5 of the radiation therapy course is assessed.	through study completion, 5 weeks

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Dirk Rades, University of Luebeck

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): April 27, 2026
• Study Completion (Actual): May 21, 2026

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; lung cancer; radiation therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Behavior; Lung Neoplasms; Motor Activity
• Other Study ID Numbers: APART-LUNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No