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

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.