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

NCT07318519 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Cancer
  • Cancer Pain
  • Chronic Cancer Pain

Interventions

DEVICE

VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management

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.

DEVICE

Active Control -- two-dimensional tablet-delivered intervention

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-01
Completion
2027-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318519 on ClinicalTrials.gov