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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Medstar Health Research Institute
Study ID
NCT07318519
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Cancer Pain
  • Chronic Cancer Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Virtual reality delivered behavioral skills for pain management
    Participants use VR-CAN therapy at home, 10 minutes per session, daily for 14 days
  • Active Comparator: Tablet-based delivery of behavioral skills for pain management
    Participants use a two-dimensional skills-based intervention delivered by handheld tablet at home, 10 minutes per session, daily for 14 days

Primary Outcome Measure

Feasibility of device use as assigned [ Time Frame: From enrollment to study completion (14 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Health Research InstituteWashington D.C.District of Columbia20010
Hunter Groninger, MD
[email protected]
202-877-7445
Duke University School of MedicineDurhamNorth Carolina27710
Sarah Kelleher, PhD
[email protected]
919-416-3405

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By research site
MedStar Health Research Institute· Washington D.C., DCDuke University School of Medicine· Durham, NC

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