Virtual Reality Therapy for Cancer-Treatment Associated Symptoms

Trial Title: Virtual Reality Therapy for Cancer-Treatment Associated Symptoms

NCT ID: NCT06248216

Condition: Cancer
Cancer Pain
Virtual Reality

Conditions: Official terms:
Cancer Pain

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: This will be a 10-week crossover design where the participants will undergo one intervention for five weeks and the other intervention for the other five weeks. Participants will be randomly assigned the order of interventions they will undergo.

Primary purpose: Treatment

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)

Masking description: The study coordinator will not be blinded as they will need to administer consents and interact with participants. However, lead study investigators and outcomes assessors will be blinded to treatment group.

Intervention:

Intervention type: Device
Intervention name: Relievrx
Description: 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.
Arm group label: Virtual reality arm

Intervention type: Other
Intervention name: Audio Mp4
Description: Audio Mp4 modules ranging from 3-15 minutes with guided meditation.
Arm group label: Audio Mp4 arm

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 88 Years

Healthy volunteers: No

Locations:

Facility:
Name: Luana Colloca

Address:
City: Baltimore
Zip: 21201-1512
Country: United States

Facility:
Name: University of Maryland

Address:
City: Baltimore
Zip: 21201-1512
Country: United States

Start date: July 2024

Completion date: August 2026

Lead sponsor:
Agency: University of Maryland, Baltimore
Agency class: Other

Source: University of Maryland, Baltimore

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06248216