Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in distress scores between pre- and post-intervention
研究概览
简要总结
The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain.
Participants will:
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Be randomly assigned to one of two available groups (virtual reality or standard of care)
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Participations will only be during one chemotherapy session.
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Those assigned to virtual reality:
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The research team will provide a virtual reality
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The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns.
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Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes
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Those assigned to the standard of care:
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The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.
详细描述
In recent decades, new cancer cases have consistently risen. Participants diagnosed with cancer commonly face psychological symptoms including distress, anxiety, and depression in addition to physical symptoms (i.e., pain). Importantly, these symptoms might be exacerbated during chemotherapy sessions. New innovative technological strategies have been under development to control the symptoms and improve quality of life. Immersive virtual reality (VR) is a simulated experience that enables participants to interact with an artificial three-dimensional visual and auditory environment. VR could be an innovative intervention to relieve psychological symptoms associated with chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Biopsy proven diagnosis of Cancer (any stage or type).
- •Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis.
- •Must have the ability to understand and the willingness to sign a written informed consent document
- •Followed by a medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic.
- •Ability to read and write in English or Spanish.
排除标准
- •Age <18 years.
- •No prior history of Cancer.
- •Prior medical history of severe motion sickness.
- •Prior medical history of seizures
- •Pregnancy.
- •Unable or unwilling to participate in the immersive Virtual Reality study at the Maroone Cancer Center
研究组 & 干预措施
Virtual reality
Participants will be asked to use a headset device during 15 to 30 minutes while receiving a chemotherapy infusion. Participants have the option to choose from different virtual reality setting depending on their preference (i.e., nature videos, meditations, interactive applications, among others).
干预措施: Virtual Reality (Device)
Virtual reality
Participants will be asked to use a headset device during 15 to 30 minutes while receiving a chemotherapy infusion. Participants have the option to choose from different virtual reality setting depending on their preference (i.e., nature videos, meditations, interactive applications, among others).
干预措施: Questionnaires (Other)
Standard of care
Participants will be asked to choose any activity of your preference during the chemotherapy session (i.e., watching tv, reading a book, listening to music or a podcast, etc.)
干预措施: Preferred activity (Other)
Standard of care
Participants will be asked to choose any activity of your preference during the chemotherapy session (i.e., watching tv, reading a book, listening to music or a podcast, etc.)
干预措施: Questionnaires (Other)
结局指标
主要结局
Change in distress scores between pre- and post-intervention
时间窗: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
The primary endpoint is the distress score change between pre- and post-intervention to evaluate the effectiveness of immersive virtual reality during chemotherapy sessions in reducing distress in participants with high levels of distress from baseline diagnosed with any type of Cancer, using The NCCN Distress Thermometer. This is a single-item questionnaire used to screen for psychological distress in participants. It consists of a simple scale ranging from 0 to 10, where participants rate their level of distress. A score of 5 or more on the NCCN Distress Thermometer indicates moderate to severe psychological distress
次要结局
- Predictor of intervention efficacy: Time since diagnosis(Day 1)
- Changes in pain scores between pre- and post-intervention(Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention)
- Predictor of intervention efficacy: Age(Day 1)
- Predictor of intervention efficacy: Ethnicity(Day 1)
- Predictor of intervention efficacy: Time since therapy initiated(Day 1)
- Changes in GAD-7 scores between pre- and post-intervention(Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention)
- Changes in CCVAS scores between pre- and post-intervention(Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention)
- Predictor of intervention efficacy: Race(Day 1)
- Predictor of intervention efficacy: Martial Status(Day 1)
- Predictor of intervention efficacy: Occupation(Day 1)
- Predictor of intervention efficacy: Current chemotherapy regimen(Day 1)
- Predictor of intervention efficacy: Attitudes towards use of virtual reality(Day 1)