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Cognitive Behavioral Theory-assisted Virtual Reality for Chronic Cancer Pain (VR-CAN): Device Prototype Development and Feasibility Testing

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Washington, D.c.
MedStar Health Research Institute
RECRUITING
Washington D.c.
North Carolina
Duke University School of Medicine
RECRUITING
Durham
Contact Information
Primary
Hunter Groninger, MD
hunter.groninger@medstar.net
202-877-7445
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Medstar Health Research Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov