Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07318519

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

Led by Medstar Health Research Institute · Updated on 2026-01-06

40

Participants Needed

2

Research Sites

25 weeks

Total Duration

On this page

Sponsors

M

Medstar Health Research Institute

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Many patients with cancer experience chronic pain that significantly affects their quality of life. This research aims to develop and test a new virtual reality (VR) therapy based on cognitive behavioral therapy (CBT) principles to help manage chronic cancer pain. The study is designed to explore the feasibility, acceptability, usability, safety, and initial clinical impact of this VR therapy compared to a tablet-based video control intervention. The study involves creating and refining a VR-CAN prototype tailored for patients with chronic cancer pain. Participants will be randomly assigned to either use the VR-CAN therapy or a tablet-based two-dimensional skills intervention. Both groups will use their assigned treatment at home for 10 minutes daily over 14 days. The VR-CAN group will experience immersive VR content designed to provide pain relief through distraction and behavioral techniques, while the control group will view non-CBT content on a tablet. Participants will complete assessments throughout the 14-day treatment period, including measures of device feasibility, acceptability, usability, safety, pain interference, mood, coping strategies, pain severity, and self-efficacy. Data will also be collected through daily pain ratings during each use of the assigned intervention. Post-intervention interviews will gather participant feedback to improve the VR therapy for future studies. The total participation time is two weeks, with no long-term follow-up described.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years old
  • Diagnosis of cancer and currently undergoing treatment
  • Chronic cancer pain lasting at least 3 months with baseline pain severity of at least 4 out of 10
Not Eligible

You will not qualify if you...

  • Experiencing intractable nausea, vomiting, motion sickness, seizures, epilepsy, or cranial abnormalities preventing use of VR headset
  • Moderate to severe pain from non-cancer causes
  • Currently enrolled in another pain study
  • Unable to complete surveys or interviews in English or Spanish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 14 days

Participants use their assigned device-based behavioral skills intervention for chronic cancer pain management at home, 10 minutes per session daily for 14 days.

Daily use at home for 14 days

Follow-up

Duration - Short period after treatment

Participants provide feedback on feasibility, acceptability, usability, safety, and initial impact of the intervention through surveys and interviews after completing the device use period.

1 post-treatment visit or assessment

Trial Site Locations

Total: 2 locations

1

MedStar Health Research Institute

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

Duke University School of Medicine

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

H

Hunter Groninger, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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