CancerVR-CANNCT07318519
Cognitive Behavioral Theory-assisted Virtual Reality for Chronic CANcer Pain (VR-CAN)
A study testing VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management in people with Cancer and Cancer Pain, run by Medstar Health Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Pain, Chronic Cancer Pain
- What is being tested?
- VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke University School of Medicine
Durham, North Carolina, 27710
Sarah Kelleher, PhD, 919-416-3405, sarah.kelleher@duke.edu
- Recruiting
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Hunter Groninger, MD, 202-877-7445, hunter.groninger@medstar.net
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Cancer, Cancer Pain, Chronic Cancer Pain
- Being tested
- VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management, Active Control -- two-dimensional tablet-delivered intervention
- Keywords
- cancer, pain, chronic pain, cognitive behavioral therapy, virtual reality
- Medical subject headings
- Neoplasms, Cancer Pain, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain managementDevice
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 interventionDevice
Also called Handheld tablet delivered two-dimensional skills based 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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality delivered behavioral skills for pain management | Experimental | Participants use VR-CAN therapy at home, 10 minutes per session, daily for 14 days Receives: 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 Receives: Device: Active Control -- two-dimensional tablet-delivered intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of device use as assigned
Protocol adherence (completion of assigned intervention).
Measured: From enrollment to study completion (14 days)
Secondary outcomes (8)
Acceptability
Client Satisfaction Questionnaire (CSQ)
Measured: From enrollment to study completion (14 days)
Usability
System Usability Scale (SUS)
Measured: From enrollment to study completion (14 days)
Safety of intervention
Participants' self-report of side effects
Measured: From enrollment to study completion (14 days)
Pain interference
Pain interference-Short Form (SF)
Measured: From enrollment to study completion (14 days)
Profile of Mood States Short Form
Measures participant psychological distress
Measured: From enrollment to study completion (14 days)
Coping Strategies Questionnaire's Pain Catastrophizing subscale
Measures participant catastrophizing of pain experience
Measured: From enrollment to study completion (14 days)
Chronic Pain Self-Efficacy Scale
Measures participant self-efficacy in pain management
Measured: From enrollment to study completion (14 days)
Pain severity
Measures severity of self-reported pain
Measured: Daily with each use of assigned intervention (during each day of 14 day participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318519
- Sponsor's protocol ID
- 1R21CA299799-01
- Other IDs
- 1R21CA299799-01
- Acronym
- VR-CAN
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Theory-assisted Virtual Reality for Chronic Cancer Pain (VR-CAN): Device Prototype Development and Feasibility Testing
- ClinicalTrials.gov ID
- NCT07318519
- Acronym / sponsor ID
- VR-CAN / 1R21CA299799-01
- Conditions
- Cancer, Cancer Pain, Chronic Cancer Pain
- Keywords
- cancer, pain, chronic pain, cognitive behavioral therapy, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality delivered behavioral skills for pain management | Experimental | Device: VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain managementParticipants use VR-CAN therapy at home, 10 minutes per session, daily for 14 days |
| Tablet-based delivery of behavioral skills for pain management | Active comparator | Device: Active Control -- two-dimensional tablet-delivered interventionParticipants use a two-dimensional skills-based intervention delivered by handheld tablet at home, 10 minutes per session, daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain managementVR-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 | Virtual reality delivered behavioral skills for pain management |
| Active Control -- two-dimensional tablet-delivered interventionAlso: Handheld tablet delivered two-dimensional skills based interventionTablet-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. | Device | Tablet-based delivery of behavioral skills for pain management |
Primary outcome
Feasibility of device use as assigned
Time frame: From enrollment to study completion (14 days)
Protocol adherence (completion of assigned intervention).
8 secondary outcomes
Acceptability
Time frame: From enrollment to study completion (14 days)
Usability
Time frame: From enrollment to study completion (14 days)
Safety of intervention
Time frame: From enrollment to study completion (14 days)
Pain interference
Time frame: From enrollment to study completion (14 days)
Profile of Mood States Short Form
Time frame: From enrollment to study completion (14 days)
Coping Strategies Questionnaire's Pain Catastrophizing subscale
Time frame: From enrollment to study completion (14 days)
Chronic Pain Self-Efficacy Scale
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management in people with Cancer and Cancer Pain, run by Medstar Health Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hunter Groninger, MD (202-877-7445, hunter.groninger@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of device use as assigned (time frame: From enrollment to study completion (14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.