Recruiting

VR-CAN

Sponsor:

Medstar Health Research Institute

Code:

NCT07318519

Conditions

Cancer

Cancer Pain

Chronic Cancer Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Active Control -- two-dimensional tablet-delivered intervention

Study Details

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

Study ID

NCT07318519

Start date

Jul 1, 2025

Status verified date

Dec, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

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

Interventions

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 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.

Primary outcome measure

  • Feasibility of device use as assigned [ Time Frame: From enrollment to study completion (14 days) ]

Central Contacts and Locations

Central contacts

Locations

MedStar Health Research Institute

Recruiting

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

Contacts

Duke University School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Jan 6, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2026-01-06.