Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study (DISCOVR)
Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) - Feasibility, Acceptability, Usability Testing of a Novel Intervention
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Virtual reality pain therapy
|
DISCOVR virtual reality pain therapy
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Hunter Groninger, MD, Medstar Health Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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