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Virtual Reality Education Before CyberKnife Treatment for Prostate Cancer

6 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
  • Número de telefone: 2125 +42059737
  • E-mail: lukas.knybel@fno.cz

Locais de estudo

  • Tcheca
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tcheca, 708 52
        • Recrutamento
        • University Hospital Ostrava
        • Contato:
        • Contato:
          • Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
          • Número de telefone: 2125 +42059737
          • E-mail: lukas.knybel@fno.cz
        • Investigador principal:
          • Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
        • Subinvestigador:
          • Andrea Šoltisová, Bc.
        • Subinvestigador:
          • David Pakizer, Mgr., Ph.D.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: VR-assisted education

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

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

Procedimento: 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
Comparador Ativo: Standard education

Study subjects randomised in this arm will receive standard education.
Procedimento: 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

Outro: Standard education

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Understanding of CyberKnife radiotherapy and preparation requirements
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient-reported clarity of education and perceived understanding
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital Ostrava

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de agosto de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

2 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FNO-ONK-VDA

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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