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

May 31, 2026 updated by: University Hospital Schleswig-Holstein

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dirk Rades, Prof. Dr. med., FASTRO
  • Phone Number: +49 45150045400
  • Email: Dirk.Rades@uksh.de

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wear-time of the smart phone
Time Frame: through study completion, 5 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Schleswig-Holstein

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dirk Rades, University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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