Cognitive Behavioral Theory-assisted Virtual Reality for Chronic Cancer Pain (VR-CAN): Device Prototype Development and Feasibility Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of device use as assigned
研究概览
简要总结
While chronic cancer pain affecting as many as 75% of patients is typically addressed using pharmacologic interventions, experts and patients alike support maximizing any relevant non-pharmacologic interventions as well, such as cognitive behavioral therapy. Virtual reality, a novel technology that can temporarily immerse users in a calm, pleasant environment, has been increasingly shown to facilitate improvement in different acute and chronic pain syndromes by providing distraction from pain and lowering pain sensation. To address the significant needs of patients living with chronic cancer pain, we aim to develop and pilot test a prototype device that will leverage cognitive behavioral therapy principles to deliver a novel virtual reality pain therapy. The investigators will do this through the following steps:
Step 1. Develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN).
Step 2. Conduct a randomized controlled trial to examine the feasibility, acceptability, usability, safety, and initial clinical impact of the developed VR-CAN prototype compared to a tablet-based two-dimensional video control group.
Step 3. Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN technology and protocol to optimize for a future, larger, fully powered randomized controlled trial.
详细描述
Over 50% of patients living with cancer experience pain early in the disease course, increasing to at least 75% of patients who have progressed to more advanced stages. Opioid therapies remain a cornerstone to chronic cancer pain management - nevertheless, clinical literature and expert opinion reinforce that maximizing effective, appropriate non-pharmacologic therapies is critical to achieving the best possible pain control, well-being, and return to function. Virtual reality (VR) is a rapidly developing technology that can temporarily immerse individuals in a calm, pleasant environment, and has demonstrated efficacy in acute and chronic pain management settings by providing distraction from pain and lowering pain sensation. Nevertheless, despite growing evidence supporting the efficacy of VR-based interventions for analgesia, few data are available that provide an understanding of its role in mitigating persistent pain in patients with cancer and existing studies have used off-the-shelf VR products that are not evidence-based or designed to meet the unique and complex needs of patients with cancer pain. This collaboration between Duke University and MedStar Health leverages experience conducting clinical trials of VR to mitigate cancer pain in both inpatient and outpatient settings, expertise in the development and implementation of behavioral pain and symptom management interventions for patients with cancer, and experience developing VR applications for healthcare settings. Following the NIH Behavioral Intervention Development Stage Model, the investigators' shared goal is to develop (i.e., patient focus groups, provider and expert interviews, patient beta testing) and pilot test a new VR therapy that integrates evidence-based strategies and is uniquely co-designed by patients living with chronic cancer pain.
Aim 1. Iteratively develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN) based on literature and the investigative team's research and clinical expertise, and feedback collected via focus groups with patients living with moderate-severe chronic cancer pain and interviews with clinical providers, and experts in the field. Leveraging human factors science, this prototype will then be tested for usability in the lab by patient participants, iteratively modified based on feedback, and then at home by unique participants daily for one week.
Aim 2. Conduct a randomized controlled trial to examine the feasibility, acceptability, usability, safety, and initial clinical impact of the developed VR-CAN prototype compared to a tablet-based two-dimensional video control group.
Aim 3 (Exploratory). Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN protocol to optimize the VR-CAN protocol that can be efficacy tested in a larger, fully powered randomized controlled trial.
Ultimately, this work has significant potential to decrease burden for a cancer population that experiences high symptom burden and disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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 at least 18 years old
- •cancer diagnosis, undergoing treatment
- •chronic cancer pain (i.e., cancer pain at least 3 months duration) with baseline pain severity at least 4/10 (where 0=no pain, 10=worst pain)
排除标准
- •intractable nausea/vomiting, motion sickness, seizures/epilepsy, and/or cranial structures/abnormalities preventing VR headset use
- •moderate-severe pain of non-cancer etiology
- •enrolled in another pain study
- •unable to complete survey measures or interviews in English or Spanish
研究组 & 干预措施
Virtual reality delivered behavioral skills for pain management
Participants use VR-CAN therapy at home, 10 minutes per session, daily for 14 days
干预措施: VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management (Device)
Tablet-based delivery of behavioral skills for pain management
Participants use a two-dimensional skills-based intervention delivered by handheld tablet at home, 10 minutes per session, daily for 14 days
干预措施: Active Control -- two-dimensional tablet-delivered intervention (Device)
结局指标
主要结局
Feasibility of device use as assigned
时间窗: From enrollment to study completion (14 days)
Protocol adherence (completion of assigned intervention).
次要结局
- Acceptability(From enrollment to study completion (14 days))
- Safety of intervention(From enrollment to study completion (14 days))
- Usability(From enrollment to study completion (14 days))
- Pain interference(From enrollment to study completion (14 days))
- Profile of Mood States Short Form(From enrollment to study completion (14 days))
- Coping Strategies Questionnaire's Pain Catastrophizing subscale(From enrollment to study completion (14 days))
- Chronic Pain Self-Efficacy Scale(From enrollment to study completion (14 days))
- Pain severity(Daily with each use of assigned intervention (during each day of 14 day participation))