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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
40
VR-CAN participants will be instructed to use the prototype VR-CAN software on the VR device at home daily for two weeks, at least 10 minutes per session, beginning the day after enrollment.
Tablet-based active control participants will follow the same prescription as the experimental arm (i.e., using assigned technology \>10 min/daily for two weeks at home), except they will view a two-dimensional, non-CBT skills version using a tablet device.
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
RECRUITINGDuke University School of Medicine
Durham, North Carolina, United States
RECRUITINGFeasibility of device use as assigned
Protocol adherence (completion of assigned intervention).
Time frame: From enrollment to study completion (14 days)
Acceptability
Client Satisfaction Questionnaire (CSQ)
Time frame: From enrollment to study completion (14 days)
Usability
System Usability Scale (SUS)
Time frame: From enrollment to study completion (14 days)
Safety of intervention
Participants' self-report of side effects
Time frame: From enrollment to study completion (14 days)
Pain interference
Pain interference-Short Form (SF)
Time frame: From enrollment to study completion (14 days)
Profile of Mood States Short Form
Measures participant psychological distress
Time frame: From enrollment to study completion (14 days)
Coping Strategies Questionnaire's Pain Catastrophizing subscale
Measures participant catastrophizing of pain experience
Time frame: From enrollment to study completion (14 days)
Chronic Pain Self-Efficacy Scale
Measures participant self-efficacy in pain management
Time frame: From enrollment to study completion (14 days)
Pain severity
Measures severity of self-reported pain
Time frame: Daily with each use of assigned intervention (during each day of 14 day participation)
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