Virtual Reality Therapy for Cancer-Treatment Associated Symptoms

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06248216
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Cancer Pain
  • Virtual Reality

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • Relievrx — DEVICE
    The RelieVRx program is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.
  • Audio Mp4 — OTHER
    Audio Mp4 modules ranging from 3-15 minutes with guided meditation.

Study Details

We propose an innovative approach to symptom management in cancer patients following cancer treatments, utilizing a Multimodal Integrative Therapy (MIT) delivered via Virtual Reality (VR) program, authorized by the US Food and Drug Administration for in-home use. Our primary goal is to generate pilot data on the effects of MIT-VR program on pain, fatigue, sleep, depression, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.

Key Dates

Start date
Dec 4, 2024
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Virtual reality arm
    In the virtual reality intervention, participants will complete the scheduled educational module five times in the week of the intervention. This VR is assisting users in using immersive reality to reduce pain, learning cognitive and behavior self-coping skills and retraining the pain pathways. There are several sessions, which will be delivered using an all-in-one head-mounted display. Each session varies in duration approximately from 3 to 15 minutes.
  • Placebo Comparator: Audio Mp4 arm
    In the audio intervention, participants will complete the scheduled module 5 times a week of the intervention. The content is similar to that of the VR, which will be delivered by the audio player. Each session varies in duration approximately from 3 to 15 minutes.

Primary Outcome Measure

VR effect on perceived pain [ Time Frame: Baseline to end of intervention (4 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Luana CollocaBaltimoreMaryland21201-1512
Luana Colloca, MD,PhD,MS
[email protected]
301-364-8089
Kendyl Carlisle, MD (SUB_INVESTIGATOR)
Julia Terhune, MD (SUB_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201-1512
Luana Colloca, MD, PhD, MS
[email protected]
301-364-8089
Katia Matychak, MS
[email protected]
4107065975

Find similar trials in Baltimore, MD

By research site
Luana Colloca· Baltimore, MDUniversity of Maryland· Baltimore, MD

Related Studies