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

January 2, 2026 updated by: Medstar Health Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Over 50% of patients living with cancer experience pain early in the disease course, increasing to at least 75% of patients who have progressed to more advanced stages. Opioid therapies remain a cornerstone to chronic cancer pain management - nevertheless, clinical literature and expert opinion reinforce that maximizing effective, appropriate non-pharmacologic therapies is critical to achieving the best possible pain control, well-being, and return to function. Virtual reality (VR) is a rapidly developing technology that can temporarily immerse individuals in a calm, pleasant environment, and has demonstrated efficacy in acute and chronic pain management settings by providing distraction from pain and lowering pain sensation. Nevertheless, despite growing evidence supporting the efficacy of VR-based interventions for analgesia, few data are available that provide an understanding of its role in mitigating persistent pain in patients with cancer and existing studies have used off-the-shelf VR products that are not evidence-based or designed to meet the unique and complex needs of patients with cancer pain. This collaboration between Duke University and MedStar Health leverages experience conducting clinical trials of VR to mitigate cancer pain in both inpatient and outpatient settings, expertise in the development and implementation of behavioral pain and symptom management interventions for patients with cancer, and experience developing VR applications for healthcare settings. Following the NIH Behavioral Intervention Development Stage Model, the investigators' shared goal is to develop (i.e., patient focus groups, provider and expert interviews, patient beta testing) and pilot test a new VR therapy that integrates evidence-based strategies and is uniquely co-designed by patients living with chronic cancer pain.

Aim 1. Iteratively develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN) based on literature and the investigative team's research and clinical expertise, and feedback collected via focus groups with patients living with moderate-severe chronic cancer pain and interviews with clinical providers, and experts in the field. Leveraging human factors science, this prototype will then be tested for usability in the lab by patient participants, iteratively modified based on feedback, and then at home by unique participants daily for one week.

Aim 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.

Aim 3 (Exploratory). Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN protocol to optimize the VR-CAN protocol that can be efficacy tested in a larger, fully powered randomized controlled trial.

Ultimately, this work has significant potential to decrease burden for a cancer population that experiences high symptom burden and disability.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality delivered behavioral skills for pain management
Participants use VR-CAN therapy at home, 10 minutes per session, daily for 14 days
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.
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
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.
Other Names:
  • Handheld tablet delivered two-dimensional skills based intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of device use as assigned
Time Frame: From enrollment to study completion (14 days)
Protocol adherence (completion of assigned intervention).
From enrollment to study completion (14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: From enrollment to study completion (14 days)
Client Satisfaction Questionnaire (CSQ)
From enrollment to study completion (14 days)
Usability
Time Frame: From enrollment to study completion (14 days)
System Usability Scale (SUS)
From enrollment to study completion (14 days)
Safety of intervention
Time Frame: From enrollment to study completion (14 days)
Participants' self-report of side effects
From enrollment to study completion (14 days)
Pain interference
Time Frame: From enrollment to study completion (14 days)
Pain interference-Short Form (SF)
From enrollment to study completion (14 days)
Profile of Mood States Short Form
Time Frame: From enrollment to study completion (14 days)
Measures participant psychological distress
From enrollment to study completion (14 days)
Coping Strategies Questionnaire's Pain Catastrophizing subscale
Time Frame: From enrollment to study completion (14 days)
Measures participant catastrophizing of pain experience
From enrollment to study completion (14 days)
Chronic Pain Self-Efficacy Scale
Time Frame: From enrollment to study completion (14 days)
Measures participant self-efficacy in pain management
From enrollment to study completion (14 days)
Pain severity
Time Frame: Daily with each use of assigned intervention (during each day of 14 day participation)
Measures severity of self-reported pain
Daily with each use of assigned intervention (during each day of 14 day participation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21CA299799-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the Data Sharing for Demographic Research (DSDR).

IPD Sharing Time Frame

Data will become available upon completion of the study and dissemination of findings.

IPD Sharing Access Criteria

All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via DSDR. Users of the public use data must register with ICPSR and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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