Recruiting

Virtual Reality Therapy

Sponsor:

University of Maryland, Baltimore

Code:

NCT06248216

Conditions

Cancer

Cancer Pain

Virtual Reality

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Relievrx

Audio Mp4

Study Details

Brief summary:

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.

Conditions

Cancer

Cancer Pain

Virtual Reality

Study ID

NCT06248216

Start date

Dec 4, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ages 18-88
  • Cancer diagnosis (histology verified)
  • Had surgical intervention, completed chemotherapy or radiation for therapeutic purposes

->3 months since last cancer treatment, but participants currently undergoing endocrine or immunotherapy treatments are permissible
  • Documented symptoms of cancer or cancer therapy including at least one of the following: pain, anxiety, sleep difficulty, fatigue, neuropathy
  • English speaker (written and spoken)

Exclusion Criteria:

  • Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years
  • Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
  • Diagnosis and treatment of chronic pain, neuropathy, fatigue, sleep or anxiety disorder prior to cancer diagnosis
  • Current Hospice or palliative care only recipients
  • Color-blindness
  • Impaired or uncorrected hearing
  • Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
  • Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
  • Known history of severe motion sickness
  • Pregnancy or breast feeding

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Relievrx

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

Audio Mp4 modules ranging from 3-15 minutes with guided meditation.

Primary outcome measure

  • VR effect on perceived pain [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • VR effect on perceived fatigue [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • VR effect on perceived anxiety [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Audio effect on perceived pain [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Audio effect on perceived fatigue [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Audio effect on perceived anxiety [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Difference in effect of VR vs audio MP4 intervention on pain [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Difference in effect of VR vs audio MP4 intervention on fatigue [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Difference in effect of VR vs audio MP4 intervention on anxiety [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • VR effect on perceived depression [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Audio effect on perceived depression [ Time Frame: Baseline to end of intervention (4 weeks) ]
  • Difference in effect of VR vs audio MP4 intervention on depression [ Time Frame: Baseline to end of intervention (4 weeks) ]

Central Contacts and Locations

Central contacts

Katia Matychak, MS

410-706-5975katiamatychak@umaryland.edu

Locations

Luana Colloca

Recruiting

Baltimore, Maryland, United States, 21201-1512

Contacts

Luana Colloca, MD,PhD,MS

301-364-8089Colloca@umaryland.edu

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201-1512

Contacts

Luana Colloca, MD, PhD, MS

301-364-8089colloca@umaryland.edu

Katia Matychak, MS

4107065975katiamatychak@umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-04-29.