Virtual Reality Education Before CyberKnife Treatment for Prostate Cancer
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jiří Hynčica
- 전화번호: 2587 +42059737
- 이메일: jiri.hyncica@fno.cz
연구 연락처 백업
- 이름: Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
- 전화번호: 2125 +42059737
- 이메일: lukas.knybel@fno.cz
연구 장소
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, 체코, 708 52
- 모병
- University Hospital Ostrava
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연락하다:
- Jiří Hynčica
- 전화번호: 2587 +42059737
- 이메일: jiri.hyncica@fno.cz
-
연락하다:
- Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
- 전화번호: 2125 +42059737
- 이메일: lukas.knybel@fno.cz
-
수석 연구원:
- Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
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부수사관:
- Andrea Šoltisová, Bc.
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부수사관:
- David Pakizer, Mgr., Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: VR-assisted education
Study subjects randomised in this arm will receive VR-assisted education. |
VR-assisted education will be provided for study subjects randomised in this intervention group. 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 |
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활성 비교기: Standard education
Study subjects randomised in this arm will receive standard education. |
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 Standard education will be provided for study subjects randomised in this intervention group. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Understanding of CyberKnife radiotherapy and preparation requirements
기간: On Day 1 of the treatment - after completion of patient education and before the first irradiation
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient-reported clarity of education and perceived understanding
기간: On Day 1 of the treatment - after completion of patient education and before the first irradiation
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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
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Patient-reported psychological responses before the first irradiation
기간: Before the first CyberKnife treatment fraction
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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
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Patient-reported usefulness and tolerability of VR education
기간: Before the first CyberKnife treatment fraction, referring to the preceding VR education session
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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
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Adequacy of patient preparation and treatment workflow
기간: Before the 1st fraction
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lukáš Knybel, Assoc.Prof., Ing., Ph.D., University Hospital Ostrava
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FNO-ONK-VDA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
There is no plan to make individual participant data accessible, the data may be provided upon reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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