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Clinical Trial 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, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.

Clinical Trial Description

All of the study procedures will be completed over the course of one month, during which participants will make four visits or phone calls (one virtual enrollment visit followed by 3 virtual follow up visits/phone calls). Participants will be randomly assigned in a 1:1 fashion to one of two different interventions: virtual reality or Mp4 audio. At home, participants will engage in their assigned intervention 5x throughout the week using the provided device and fill out required questionnaires. 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. Similarly, 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. The first visit is an enrollment visit. The rest of the 3 follow-up visits will take place throughout the month-long intervention period. 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 3 follow up visits, we will address questions and issues that arise for participants to ensure compliance. Participants will return the provided devices upon completing the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06248216
Study type Interventional
Source University of Maryland, Baltimore
Status Not yet recruiting
Phase N/A
Start date February 2024
Completion date February 2025

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