Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Virtual Reality Education Before CyberKnife Treatment for Prostate Cancer

6 novembre 2026 mis à jour par: University Hospital Ostrava

Virtual Doctor's Assistant: A Study of Virtual Reality Education Before Treatment to Improve Understanding in Patients With Prostate Cancer Undergoing CyberKnife Radiotherapy

This randomized controlled study evaluates virtual reality education for men aged 40 to 80 years with prostate cancer who are scheduled for CyberKnife radiotherapy at the University Hospital Ostrava. Participants are assigned in a 1:1 ratio to standard patient education alone or standard education supplemented by the Virtual Doctor's Assistant. The virtual environment reproduces the CyberKnife treatment room and explains the equipment, the treatment process, and the importance of consistent bladder and rectal preparation. The study aims to reduce stress before treatment and improve patients' understanding of the procedure and preparation requirements. Cancer treatment itself is unchanged. Outcomes will be assessed using patient questionnaires.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Patients preparing for radiotherapy need to understand both the treatment procedure and the steps they should take before each treatment session. For prostate radiotherapy, consistent bladder and rectal filling is an important component of treatment preparation. Unfamiliarity with the treatment room and equipment may also contribute to stress before the first irradiation.

The Virtual Doctor's Assistant is a virtual reality (VR) educational system developed to supplement the information provided by the treating physician. Using a VR headset, participants enter a computer-generated representation of the CyberKnife treatment room. A virtual doctor introduces the main components of the equipment, explains the treatment process, and demonstrates how preparation affects the anatomical relationships between the prostate, bladder, and rectum.

Men with prostate cancer scheduled for CyberKnife radiotherapy at University Hospital Ostrava will be assigned at random to one of two groups, with an equal probability of receiving standard education alone or standard education supplemented by VR. The radiotherapy procedure will follow standard clinical practice in both groups. Participation is voluntary, and participants may discontinue the VR experience or withdraw from the study.

The study will compare patient-reported psychological well-being and understanding of treatment and preparation requirements between the groups All measurements will be conducted using standardized collection protocols and under consistent environmental and procedural conditions to ensure reproducibility and comparability of data.

Type d'étude

Interventionnel

Inscription (Estimé)

100

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.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
  • Numéro de téléphone: 2125 +42059737
  • E-mail: lukas.knybel@fno.cz

Lieux d'étude

  • Tchéquie
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tchéquie, 708 52
        • Recrutement
        • University Hospital Ostrava
        • Contact:
        • Contact:
          • Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
          • Numéro de téléphone: 2125 +42059737
          • E-mail: lukas.knybel@fno.cz
        • Chercheur principal:
          • Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
        • Sous-enquêteur:
          • Andrea Šoltisová, Bc.
        • Sous-enquêteur:
          • David Pakizer, Mgr., Ph.D.

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

40 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  • Male patients aged 40 to 80 years
  • Diagnosis of prostate cancer
  • Indication for CyberKnife SBRT at the Oncology Department of University Hospital Ostrava
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Not signing the informed consent

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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: VR-assisted education

Study subjects randomised in this arm will receive VR-assisted education.
Autre: VR-assisted education

VR-assisted education will be provided for study subjects randomised in this intervention group.

Procédure: Stereotactic radiosurgery

Stereotactic radiosurgery is a non-surgical radiation therapy that uses precisely focused beams of high-dose radiation to treat small tumors, lesions, or functional abnormalities
Comparateur actif: Standard education

Study subjects randomised in this arm will receive standard education.
Procédure: Stereotactic radiosurgery

Stereotactic radiosurgery is a non-surgical radiation therapy that uses precisely focused beams of high-dose radiation to treat small tumors, lesions, or functional abnormalities

Autre: Standard education

Standard education will be provided for study subjects randomised in this intervention group.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Understanding of CyberKnife radiotherapy and preparation requirements
Délai: On Day 1 of the treatment - after completion of patient education and before the first irradiation

The primary outcome measure is to assess and compare patients' understanding of CyberKnife radiotherapy and preparation requirements between the VR-assisted education group and the standard education group. Understanding will be assessed using the five-item knowledge test in Part 2 of the study-specific questionnaire. Each correct answer will receive one point, yielding a total score from 0 to 5, with higher scores indicating better understanding. The questions cover the treatment schedule, bladder and rectal preparation, the importance of consistent anatomical conditions, the consequences of inadequate preparation, and cooperation during irradiation.
On Day 1 of the treatment - after completion of patient education and before the first irradiation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient-reported clarity of education and perceived understanding
Délai: On Day 1 of the treatment - after completion of patient education and before the first irradiation

Patients' perceptions of the clarity of the information provided, their ability to anticipate the first irradiation, and their understanding of preparation requirements will be assessed using Part 1 of the questionnaire. Four items are rated on a five-point agreement scale, from 1 (strongly agree) to 5 (strongly disagree), with lower scores indicating more favourable responses. A separate three-category item assesses whether patients perceive their understanding to have improved following education. Responses will be compared between groups and analysed separately.
On Day 1 of the treatment - after completion of patient education and before the first irradiation
Patient-reported psychological responses before the first irradiation
Délai: Before the first CyberKnife treatment fraction

Current stress, concerns about the treatment room experience, and confidence in knowing what to expect during treatment will be assessed using the three separate numerical rating scales in Part 3 of the questionnaire. Each item is rated from 0 to 10. Higher scores indicate greater stress, greater concerns, and greater confidence, respectively. Each item will be analysed separately and compared between groups.
Before the first CyberKnife treatment fraction
Patient-reported usefulness and tolerability of VR education
Délai: Before the first CyberKnife treatment fraction, referring to the preceding VR education session

Part 4 of the questionnaire will assess the VR group's perceptions of how VR helped them visualise the treatment room, understand treatment and preparation requirements, and reduce concerns. Willingness to recommend VR education will also be assessed. These four items use a five-point agreement scale, from 1 (strongly agree) to 5 (strongly disagree). A separate categorical item records discomfort experienced during VR use, including nausea, dizziness, or other symptoms. Responses will be analysed descriptively within the VR group.
Before the first CyberKnife treatment fraction, referring to the preceding VR education session
Adequacy of patient preparation and treatment workflow
Délai: Before the 1st fraction

Patient preparation will be evaluated indirectly by assessing prostate position on pre-treatment X-ray images acquired before each CyberKnife treatment fraction. Prostate localisation will be based on implanted fiducial markers. Deviations from the planned reference position will be recorded and compared between the VR-assisted education group and the standard education group.
Before the 1st fraction

Collaborateurs et enquêteurs

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

Parrainer

University Hospital Ostrava

Les enquêteurs

  • Chercheur principal: Lukáš Knybel, Assoc.Prof., Ing., Ph.D., University Hospital Ostrava

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)

1 août 2026

Achèvement primaire (Estimé)

1 août 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

2 novembre 2026

Première soumission répondant aux critères de contrôle qualité

6 novembre 2026

Première publication (Réel)

12 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FNO-ONK-VDA

Plan pour les données individuelles des participants (IPD)

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

NON

Description du régime IPD

There is no plan to make individual participant data accessible, the data may be provided upon reasonable request.

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 .

S'abonner