Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain Management in Advanced Cancer Patients: Protocol for Efficacy, Feasibility, and Safety in a Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Chane in Pain score
研究概览
简要总结
Introduction Patients with advanced cancer often experience high levels of debilitating pain and pain-related psychological distress. Although there is increasing evidence that non-pharmacological strategies are needed to treat their pain, pharmacologic modalities remain the preferred strategy. Guided imagery is a form of focused relaxation that helps create harmony between the mind and body and has been shown to significantly improve cancer pain. This study presents Virtual Reality Assisted Guided Imagery (VRAGI) as an alternative pain treatment modality. The investigators of this study will conduct a randomized control trial to test its efficacy, feasibility, and safety in the home setting, for patients with advanced cancer.
Methods and Analysis The study will recruit 80 participants from Prisma Health, a tertiary level health care center based in Greenville, South Carolina, USA using a stringent set of inclusion and exclusion criteria. The prospective 6-week, 2x2 randomized controlled trial will randomize participants to four groups: (1) VRAGI, (2) Laptop Assisted Guided Imagery (AGI), (3) VR (no guided imagery or other audio), and (4) laptop (no guided imagery or other audio). Participants allocated to VR groups will be trained to use a head-mounted display (HMD) that immerses them in 3D audio-video content. The non-VR group will use a laptop displaying 2D video content. Content includes relaxing natural scenes across three calendar seasons (spring, summer, fall). Investigators will collect measures pre, during, and post intervention including patient reported outcomes (PROs) of pain, anxiety, depression, fatigue. Additionally, investigators will assess the feasibility, acceptability and safety of VRAGI use in a home setting.
Trial Registration Number
#Pro00114598
Strengths and Limitations
- This study uses a novel design that combines the use of immersive Virtual Reality (VR) technology with guided imagery processes to treat chronic pain in advanced cancer patients.
- Investigators propose a reproducible intervention that can be self-administered in a home setting, thus eliminating the need for trained personnel, transportation modalities, or healthcare facilities.
- VR content will be preloaded onto HMDs, thus eliminating the need for access to the internet and decreasing the variability of the intervention.
- Investigators will collect patient reported outcomes (PROs) on pain, anxiety, depression, fatigue, and opioid use, but not continuous user feedback or biofeedback.
- This study focuses on patients < 65 years of age with advanced cancer. This allows the study to focus on a large group of patients but may limit the overall generalizability of the findings.
详细描述
Objectives
The primary aim of this pilot study is to measure the improvement in pain using virtual reality assisted guided imagery in participants with advanced cancer. The study will utilize a novel approach where participants will be asked to wear a virtual reality head-mounted display presenting immersive virtual reality assisted guided imagery (VRAGI) content in a home setting. In addition to measuring the improvement in pain, this study seeks to: (1) assess the efficacy of immersive VR assisted guided imagery on patient-reported outcomes (PROs), including anxiety and opioid use among patients with advanced cancer (2) measure feasibility, acceptance, and safety of VR-assisted guided imagery in a home setting. The study will recruit 80 participants from Prisma Health Upstate Outpatient Cancer Clinics, who will be randomized to four groups after enrollment:
Participants in all groups will continue to receive the current standard of symptom management treatment. Eligible participants in the VR group will be trained to use a VR head-mounted display (HMD) in the comfort of their own home for self-treatment of cancer pain. The objective is to gather data on participants with advanced cancer after being exposed to 3 weeks of Virtual Reality Assisted Guided Imagery (VRAGI). The study will collect patient reported outcomes (PROs) including pain, anxiety, depression, fatigue, and opioid use. The investigators will also measure feasibility, acceptability and safety of VRAGI at home. The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts, and feelings about the VR experience. Outcomes will be measured before, during, and after a three-week intervention period and compared with the control group. The investigators expect that this study will demonstrate that VRAGI is an effective non-pharmacologic treatment for the management of cancer pain; moreover, the investigators expect VRAGI will be feasibly and safely deployed in home settings.
Study Design Randomized control trial: The study will recruit 80 participants. Once recruited, participants will be screened using the inclusion and exclusion criterion to ensure study eligibility. Eligible participants will be randomized to the intervention and control groups using Redcap software.
Setting The study will recruit 80 participants from Prisma Health Cancer Institute Outpatient Clinics. Once recruited, participants will be screened using the inclusion and exclusion criterion to ensure study eligibility. Participants will experience the intervention in a home setting. Investigators will evaluate the effects of two two-level factors: "Guided imagery" and "VR immersion." The four arms of the study consists of: (1) VRAGI, (2) Laptop AGI, (3) VR (no guided imagery or other audio), and (4) laptop (no guided imagery or other audio). Randomization of participants will be performed via Research Electronic Data Capture (REDCap) using a 1:1:1:1 allocation between the four study groups. During recruitment, we will randomly assign participants who fulfill the inclusion and exclusion criteria to one of the four study groups while balancing age, gender, and cancer progression. Eligible participants in the VRAGI or VR (no GI or other audio) arms will be trained to use a VR head-mounted display (HMD) at home. Participants in the other two groups will use a laptop to watch the same visual content shown in the HMDs. Treatment sessions will last 15-20 min and will occur once a day for three weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participants, care providers and investigators will be blinded. Randomization will be done via REDCap software
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Advanced cancer, defined as cancer that is incurable including locally advanced and metastatic cancers, with no plan for resection during the study period.
- •Baseline pain score Edmonton Symptom Assessment Scale (ESAS) ≥ 4 (mean score during the screening week).
- •Able to provide consent and willing to comply with all study procedures, as well as comprehend spoken and written English.
- •Have access to a compatible Android, iOS smartphone, personal laptop, or desktop computer (excluding tablets) to complete surveys and respond to emails
排除标准
- •Have a condition that interferes with VR usage including history of seizure, facial injury precluding safe placement of an HMD, or other visual or hearing impairment that impacts ability to participate.
- •Participated in a previous VR clinical study.
- •Underwent a surgical procedure within 8 weeks.
- •Have a neurocognitive disorder according to past medical history.
- •Have brain metastases.
- •Have a prognosis of <3 months from the time of enrollment per treating oncologist.
- •Experience current substance abuse.
- •Experienced complex childhood trauma.
- •Diagnosed with serious mental illness.
- •>65 years of age
结局指标
主要结局
Chane in Pain score
时间窗: End of week 1,2, 3 and 6
Change in pain interference as assessed with the Brief Pain Inventory (BPI) \[ Time Frame: Pre-Intervention(baseline), weekly at the end of week 1, 2, 3, and week 6\] Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain" and "least pain" over the last 7 days and "pain right now". An average of the responses to these items is used to create a single pain severity score.
次要结局
- Proportion of participants that completed intervention per study protocol.(Assessed at the end 6 weeks)
- Change in Anxiety score, Edmonton Symptom Assessment Scale (ESAS)(end of week 1, 2, 3 and 6)
- Change in Depression score, Edmonton Symptom Assessment Scale (ESAS)(end of week 1, 2, 3 and 6)
- Percentage reduction in opioid use(Daily assessed In a 6-week period. Comparing the change from study baseline to Day 7, Day 14, Day 21 and Day 42 in MME of prescribed medication.)
- Proportion of participants that develop adverse events.(Assessed on Day 1 and then weekly at end of week 1, 2 and 3)
- Median acceptability score.(Assessed weekly at end of week 1, 2, 3 and 6)