Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248216
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-01-18
Brief Title:
Virtual Reality Therapy for Cancer-Treatment Associated Symptoms
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None