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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 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Satisfaction with the reminder app
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 mars 2026

Achèvement primaire (Réel)

21 avril 2026

Achèvement de l'étude (Réel)

21 avril 2026

Dates d'inscription aux études

Première soumission

5 mai 2026

Première soumission répondant aux critères de contrôle qualité

12 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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