An App to Identify Radiation Pneumonitis - a Pre-Study in Healthy Volunteers (POLCAR-HV)

September 11, 2026 updated by: University Hospital Schleswig-Holstein

An App to Identify Radiation Pneumonitis in Lung Cancer Patients - a Pre-Study in Healthy Volunteers

Radiation pneumonitis is a possible side effect of radiotherapy for lung cancer. Since it often occurs only several weeks following radiotherapy, the corresponding symptoms may not be associated with previous administered radiotherapy. As a consequence, pneumonitis may be diagnosed very late or even be missed. Based on the findings of two prospective trials, a mobile application (PneumoCheck) has been developed, which can be used by the patients at home. This app may contribute to an earlier detection of radiation pneumonitis. Before this app can be tested in patients, its usability needs to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate the usability of the app. The healthy volunteers have to download the PneumoCheck app, which has been designed by the Luebeck based company Nextlabel Offene Handelsgesellschaft (OHG). After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer belongs to the most common types of solid cancer in Europe and Northern America. Most patients with small-cell lung cancer receive radiotherapy in combination with chemotherapy as definitive treatment. Also, a considerable number of patients with advanced non-small-cell lung cancer are treated with radiotherapy with or without concurrent chemotherapy. Radiation pneumonitis is a possible side effect of radiotherapy for lung cancer. Severe pneumonitis was reported to be fatal in approximately 2% of patients experiencing this adverse event. Pneumonitis may occur only several weeks or even months following radiotherapy. The symptoms may not be associated with the previously administered radiation treatment, and pneumonitis may be missed. Symptoms of pneumonitis generally include cough, shortness of breath, and fever. In a previous prospective trial (PARALUC), a scoring system was developed to contribute to a more precise and earlier detection of symptomatic radiation pneumonitis (grade ≥2) after radiotherapy for lung cancer. In that trial, 0 to 3 scoring points were assigned to each of the three symptoms mentioned above. Thus, patient scores ranged between 0 and 9 points. The optimal cut-off score for identification of pneumonitis was found to be 5 points. Moreover, an increase by 3 or more points from the baseline score was significantly associated with pneumonitis. Since the PARALUC trial was performed in lung cancer patients of any age, it was not clear whether its results were applicable to elderly patients known to have a higher risk of developing pneumonitis. Therefore, the POLCAR trial was performed in lung cancer patients aged ≥65 years. In that trial, the optimal cut-off score for identification of pneumonitis was 4 points, and an increase by 2 or more points compared to baseline was associated with pneumonitis. Based on the results from the PARALUC and the POLCAR trial, an app (PneumoCheck) was developed. Before this app can be tested in a prospective trial involving patients, its usability needs to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate ten aspects related to the usability of the app.

This is a prospective multi-center study (one arm), which is performed in 30 healthy volunteers. Inclusion criteria are possession of and ability to use a smart phone, age of at least 18 years, written informed consent, and capacity of the participant to consent. Patients with expected non-compliance will not be included. The healthy volunteers have to download the PneumoCheck app, which has been designed by the Lübeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app. Recruitment of all participants should be completed within 1 month. The study for each participant takes only 1 day. Thus, the expected total running time for this study is 1 month. The primary objective of this study is to evaluate the usability of the PneumoCheck app designed to identify radiation pneumonitis in lung cancer patients. Primary endpoint is satisfaction with the PneumoCheck app. In addition, iPhone and Android users will be compared.

The participants have to download the app, which has been designed by the Luebeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire (according to previous studies, Appendix III). They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

  • Name: Dirk Rades, Prof. Dr. med., FASTRO
  • Phone Number: 45400 0049-451-500
  • Email: Dirk.Rades@uksh.de

Study Contact Backup

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Department of Oncology Vejle Hospital, University Hospital of Southern Denmark
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Possession of and ability to use a smart phone
  2. Age ≥18 years
  3. Written informed consent
  4. Capacity of the participant 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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers evaluating an app
Arm Description: Participants are asked to test an app designed to contribute to the detection of radiation pneumonitis and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app.
Device: PneumoCheck app
The healthy volunteers have to download the PneumoCheck app, which has been designed by the Lübeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the PneumoCheck app
Time Frame: 1 day
The participants are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the PneumoCheck app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the reminder app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section.
1 day

Collaborators and Investigators

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

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Dirk Rades, Prof. Dr. med., FASTRO, Department of Radiation Oncology, University of Luebeck, Luebeck, Germany

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 (Estimated)

September 28, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLCAR-HV

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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