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

NCT07824544 | Not Yet Recruiting

• 1 other identifier: POLCAR-HV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Cancer

Keywords

Lung cancer; Radiotherapy; Radiation pneumonitis; Early diagnosis; Mobile application

Outcome Measures

Primary Outcomes (1)

• Satisfaction with the PneumoCheck app

  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

Study Arms (1)

Healthy volunteers evaluating an app

EXPERIMENTAL

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

Interventions

PneumoCheck app DEVICE

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.

Healthy volunteers evaluating an app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Possession of and ability to use a smart phone
• Age ≥18 years
• Written informed consent
• Capacity of the participant to consent

You may not qualify if:

• \. Expected non-compliance

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Department of Oncology Vejle Hospital, University Hospital of Southern Denmark

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms; Radiation Pneumonitis; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Rades, Prof. Dr. med., FASTRO

  Department of Radiation Oncology, University of Luebeck, Luebeck, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof. Dr. med., FASTRO

CONTACT

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

Maria K Streubel, Dr. rer. nat.

CONTACT

0049-451-500; MariaKarolin.Streubel@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective multi-center study (one arm), which is performed in 30 healthy volunteers.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)