NCT06248216

Virtual Reality Therapy for Cancer-Treatment Associated Symptoms

Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All of the study procedures will be completed over ten weeks, during which participants will complete one in-person enrollment visit per intervention and check in-phone calls as needed during the duration of each intervention. Participants will be randomly assigned in a 1:1 fashion to one of two different interventions first: virtual reality or Mp4 audio. At home, participants will engage in their assigned intervention 5x throughout the week for five weeks using the provided device and fill out required questionnaires. Once participants complete their first intervention, they will begin the second intervention. In the virtual reality intervention, participants will complete the scheduled educational module five times in each of the five weeks. 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. Similarly, in the audio intervention, participants will complete the scheduled module 5 times a week in each of the five weeks 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. The first visit is an enrollment visit. For the enrollment visit, the participant will first complete a battery of baseline surveys. They will also receive instructions about the intervention and go through the first module of the intervention to which he or she is assigned. A member of the research team will stay with the participant while the participant completes the module to ensure the proper functioning of the device and will answer any questions that may arise. The team member will also guide the participant on how to use the device. During the five weeks of the intervention, each participant can have check-in phone calls as needed. During these check-ins, we will address any questions and issues that arise for participants to encourage compliance. Participants will return the devices after each intervention.

Conditions

• Cancer
• Cancer Pain
• Virtual Reality

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Audio Mp4	Audio Mp4 modules ranging from 3-15 minutes with guided meditation.

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2024-02-08
• Last updated: 2026-01-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study