跳至主要内容
临床试验/NCT07228377
NCT07228377招募中不适用

Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) - Feasibility, Acceptability, Usability Testing of a Novel Intervention

Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Intervention feasibility

研究概览

简要总结

Patients living with cancer commonly have chronic pain due to the disease or to cancer treatments. Virtual reality, a new technology that immerses the user in pleasant, diverting, and exciting virtual environments, may lower chronic cancer pain to improve quality of life and complement need for pain medications like opioids. The investigators aim to learn from patients about the experience of cancer pain, develop a virtual reality prototype specific to cancer pain management, and test the feasibility and acceptability of this technology to improve the cancer pain experience.

详细描述

Patients living with cancer commonly experience chronic pain, defined as pain lasting at least three months. While cancer pain management has traditionally focused on pharmacologic therapies, particularly opioids, pain experts, clinical guidelines, and patients living with cancer increasingly support the use of non-pharmacologic therapies (including mind-body modalities such as distraction, mindfulness, and cognitive behavioral therapy) to mitigate pain and potentially reduce pain medication needs. Virtual reality (VR), a rapidly evolving technology that immerses the user in pleasant, virtual environments, has been shown to lower different forms of acute and chronic pain syndromes, but has not been developed specifically to improve chronic cancer pain. The long-term goal of the investigators is to develop and disseminate a patient-centered, patient-driven VR intervention that significantly improves the chronic cancer pain experience. Towards this end, they propose a multi-phase project involving active patient stakeholder input and an iterative design process that will achieve the following Specific Aims: Aim 1 - to identify patient perceptions around chronic cancer pain experiences and management strategies; Aim 2 - to develop a highly feasible, acceptable, usable, safe VR prototype enabling patient-directed management of cancer pain; Aim 3 - to conduct a trial to assess prototype feasibility, acceptability, usability, and safety. Completion of this project will lead towards development of a scalable VR intervention to mitigate pain that has potential to dramatically improve quality of life and clinical outcomes in patients living with chronic cancer pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • age ≥18 years old
  • living with active cancer diagnosis (any solid tumor type)
  • report chronic cancer pain (≥3 months) with baseline severity moderate-severe (i.e., self-report pain score (SRPS) ≥4/10, where 0=no pain, 10=worst pain)
  • prescribed chronic opioid therapies (may be long-acting formulations, short-acting formulations, or both)

排除标准

  • history of intractable nausea/vomiting, motion sickness, seizures/epilepsy, and/or cranial structure abnormalities preventing VR headset use
  • moderate-severe pain of non-cancer etiology (e.g., chronic lumbago)
  • enrolled in another pain study
  • unable to complete surveys in English or Spanish.

结局指标

主要结局

Intervention feasibility

时间窗: From enrollment to end of treatment at 7 days

\>70% of participants completing the prescribed use of VR headset daily (≥10 minutes) for one week

次要结局

  • Acceptability(Collected at end of 7 days participation)
  • Usability(Collected at end of 7 day participation)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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