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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jiří Hynčica
- 電話番号：2587 +42059737
- メール：jiri.hyncica@fno.cz
研究連絡先のバックアップ
- 名前：Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
- 電話番号：2125 +42059737
- メール：lukas.knybel@fno.cz
研究場所
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Moravian-Silesian Region
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Ostrava、Moravian-Silesian Region、チェコ、708 52
- 募集
- University Hospital Ostrava
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コンタクト：
- Jiří Hynčica
- 電話番号：2587 +42059737
- メール：jiri.hyncica@fno.cz
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コンタクト：
- Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
- 電話番号：2125 +42059737
- メール：lukas.knybel@fno.cz
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主任研究者：
- Lukáš Knybel, Assoc.Prof., Ing., Ph.D.
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副調査官：
- Andrea Šoltisová, Bc.
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副調査官：
- David Pakizer, Mgr., Ph.D.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Understanding of CyberKnife radiotherapy and preparation requirements
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-reported clarity of education and perceived understanding
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Lukáš Knybel, Assoc.Prof., Ing., Ph.D.、University Hospital Ostrava
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FNO-ONK-VDA
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
There is no plan to make individual participant data accessible, the data may be provided upon reasonable request.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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