Cognitive Behavioral Theory-assisted Virtual Reality for Chronic CANcer Pain (VR-CAN)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

age at least 18 years old

cancer diagnosis, undergoing treatment

chronic cancer pain (i.e., cancer pain at least 3 months duration) with baseline pain severity at least 4/10 (where 0=no pain, 10=worst pain)

Disqualifiers

intractable nausea/vomiting, motion sickness, seizures/epilepsy, and/or cranial structures/abnormalities preventing VR headset use

moderate-severe pain of non-cancer etiology

enrolled in another pain study

unable to complete survey measures or interviews in English or Spanish

Trial design

Treatments tested in this trial

  • VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management
  • Active Control -- two-dimensional tablet-delivered intervention

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medstar Health Research Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator