Cognitive behavioral theory-assisted virtual reality for chronic cancer pain (VR-CAN): device prototype development and feasibility testing

PROJECT ABSTRACT 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 (both sites), expertise in the development and implementation of behavioral pain and symptom management interventions for patients with cancer (Duke), and experience developing VR applications for healthcare settings (MedStar). Following the NIH Behavioral Intervention Development Stage Model, our shared goal is to develop (i.e., patient focus groups, provider and expert interviews, patient beta testing) and pilot test (RCT N=40) 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 from both urban (Washington DC) and suburban/rural (Durham, NC) communities (n=24) and interviews with providers (n=6; oncologists, nurses), and experts in the field (N=6; e.g., VR technology, cancer survivorship, non-pharmacological pain management). Leveraging human factors science, this prototype will then be tested for usability in the lab by patient participants (N=6), iteratively modified based on feedback, and then at home by unique participants (N=6) daily for one week. Aim 2. Conduct a randomized controlled trial to examine the feasibility (primary aim), acceptability, usability, safety, and initial clinical impact (pain, psychological distress, pain self-efficacy, pain catastrophizing) 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’ (60%; n=12) preferences, thoughts, and feelings about the VR-CAN protocol in order to optimize and manualize the VR- CAN protocol that can be efficacy tested in a larger, fully powered randomized controlled trial. This work has significant potential to decrease burden for a cancer population that experiences high symptom burden and disability.