- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228377
Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study (DISCOVR)
December 22, 2025 updated by: Medstar Health Research Institute
Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) - Feasibility, Acceptability, Usability Testing of a Novel Intervention
Patients living with cancer commonly have chronic pain due to the disease or to cancer treatments.
Virtual reality, a new technology that immerses the user in pleasant, diverting, and exciting virtual environments, may lower chronic cancer pain to improve quality of life and complement need for pain medications like opioids.
The investigators aim to learn from patients about the experience of cancer pain, develop a virtual reality prototype specific to cancer pain management, and test the feasibility and acceptability of this technology to improve the cancer pain experience.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients living with cancer commonly experience chronic pain, defined as pain lasting at least three months.
While cancer pain management has traditionally focused on pharmacologic therapies, particularly opioids, pain experts, clinical guidelines, and patients living with cancer increasingly support the use of non-pharmacologic therapies (including mind-body modalities such as distraction, mindfulness, and cognitive behavioral therapy) to mitigate pain and potentially reduce pain medication needs.
Virtual reality (VR), a rapidly evolving technology that immerses the user in pleasant, virtual environments, has been shown to lower different forms of acute and chronic pain syndromes, but has not been developed specifically to improve chronic cancer pain.
The long-term goal of the investigators is to develop and disseminate a patient-centered, patient-driven VR intervention that significantly improves the chronic cancer pain experience.
Towards this end, they propose a multi-phase project involving active patient stakeholder input and an iterative design process that will achieve the following Specific Aims: Aim 1 - to identify patient perceptions around chronic cancer pain experiences and management strategies; Aim 2 - to develop a highly feasible, acceptable, usable, safe VR prototype enabling patient-directed management of cancer pain; Aim 3 - to conduct a trial to assess prototype feasibility, acceptability, usability, and safety.
Completion of this project will lead towards development of a scalable VR intervention to mitigate pain that has potential to dramatically improve quality of life and clinical outcomes in patients living with chronic cancer pain.
Study Type
Interventional
Enrollment (Estimated)
25
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
- Name: Hunter Groninger, MD
- Phone Number: 202-877-7445
- Email: hunter.groninger@medstar.net
Study Contact Backup
- Name: Eloisa Leiva
- Email: eloisa.leiva@medstar.net
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20010
- Recruiting
- MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center
-
Contact:
- Eloisa Leiva
- Phone Number: (202) 877-5468
- Email: eloisa.leiva@medstar.net
-
-
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 ≥18 years old
- living with active cancer diagnosis (any solid tumor type)
- report chronic cancer pain (≥3 months) with baseline severity moderate-severe (i.e., self-report pain score (SRPS) ≥4/10, where 0=no pain, 10=worst pain)
- prescribed chronic opioid therapies (may be long-acting formulations, short-acting formulations, or both)
Exclusion Criteria:
- history of intractable nausea/vomiting, motion sickness, seizures/epilepsy, and/or cranial structure abnormalities preventing VR headset use
- moderate-severe pain of non-cancer etiology (e.g., chronic lumbago)
- enrolled in another pain study
- unable to complete surveys 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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality pain therapy
|
DISCOVR virtual reality pain therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention feasibility
Time Frame: From enrollment to end of treatment at 7 days
|
>70% of participants completing the prescribed use of VR headset daily (≥10 minutes) for one week
|
From enrollment to end of treatment at 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: Collected at end of 7 days participation
|
Technology Acceptance Model questionnaire
|
Collected at end of 7 days participation
|
|
Usability
Time Frame: Collected at end of 7 day participation
|
System Usability Scale
|
Collected at end of 7 day participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hunter Groninger, MD, Medstar Health Research Institute
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)
December 1, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Estimated)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
December 24, 2025
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00010075
- 1R43CA302795-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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