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

NCT07318519 | Recruiting

• 1 other identifier: 1R21CA299799-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

cancer; pain; chronic pain; cognitive behavioral therapy; virtual reality

Outcome Measures

Primary Outcomes (1)

• Feasibility of device use as assigned

  Protocol adherence (completion of assigned intervention).

  From enrollment to study completion (14 days)

Secondary Outcomes (8)

• Acceptability

  From enrollment to study completion (14 days)

• Usability

  From enrollment to study completion (14 days)

• Safety of intervention

  From enrollment to study completion (14 days)

• Pain interference

  From enrollment to study completion (14 days)

• Profile of Mood States Short Form

  From enrollment to study completion (14 days)

Study Arms (2)

Virtual reality delivered behavioral skills for pain management

EXPERIMENTAL

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

Tablet-based delivery of behavioral skills for pain management

ACTIVE COMPARATOR

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

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.

Virtual reality delivered behavioral skills for pain management

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.

Also known as: Handheld tablet delivered two-dimensional skills based intervention

Tablet-based delivery of behavioral skills for pain management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Medstar Health Research Institute: lead

Study Sites (2)

MedStar Health Research Institute

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

RECRUITING

Duke University School of Medicine

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Cancer Pain; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hunter Groninger, MD

CONTACT

202-877-7445; hunter.groninger@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: January 6, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available upon completion of the study and dissemination of findings.
• 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.

Locations

US (2)