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A Reminder App to Improve Physical Activity During Radiotherapy for Lung Cancer - a Pre-study in Healthy Volunteers (APART-LUNG)

12. Mai 2026 aktualisiert von: University Hospital Schleswig-Holstein

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 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 has been developed within the Interreg project HeAT (Health Advancing Technologies for Elderly). However, before this app can be tested in a prospective trial involving patients, its usability should 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.

The healthy volunteers have to download a reminder app, which has been designed by the Lübeck 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 reminder 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. In addition, iPhone and Android users are compared with respect to the satisfaction rates.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Lung cancer belongs to the most common types of solid cancer in Europe and Northern America. A considerable number of patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) 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. In a retrospective study of 184 cancer patients (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 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 has been developed within the Interreg project HeAT (Health Advancing Technologies for Elderly). However, before this app can be tested in a prospective trial involving patients, its usability should 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 study will be followed by a clinical trial in lung cancer patients.

The primary objective of this study is to evaluate the usability of a reminder app designed to improve physical activity during radiation therapy for lung cancer. This is a prospective multi-center study (one arm), which is performed in 30 healthy volunteers. The healthy volunteers have to download a reminder 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 reminder 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. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Deutschland, 23562
        • Department of Radiation Oncology, University of Luebeck
      • Vejle, Dänemark, 7100
        • Department of Oncology Vejle Hospital, University Hospital of Southern Denmark

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

1. Expected non-compliance

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Healthy volunteers evaluating a reminder app
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 reminder app.
The participants evaluate a mobile app installed on their smart phone reminding them several times daily to perform a certain number of steps. the participants are asked to complete a questionnaire and to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Satisfaction with the reminder app
Zeitfenster: Day 1
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 reminder 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.
Day 1

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Dirk Rades, Prof. Dr. med., FASTRO, University of Luebeck, Germany

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. März 2026

Primärer Abschluss (Tatsächlich)

21. April 2026

Studienabschluss (Tatsächlich)

21. April 2026

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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