NCT Number: NCT06248216
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.
Interested in participating?
Request Info18 year–88 year
All sexes
Interventional
Not applicable
Luana Colloca, Baltimore, Maryland, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
->3 months since last cancer treatment, but participants currently undergoing endocrine or immunotherapy treatments are permissible
Exclusion criteria
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 modules ranging from 3-15 minutes with guided meditation.
Time frame: Baseline to end of intervention (4 weeks)
During daily intervention sessions (VR), participants will be required to do a pre-intervention and post-intervention survey regarding their pain (REDCAP visual analog pain survey). The post-surveys will be compared to the pre-surveys to determine VR's effect on participant pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.
Time frame: Baseline to end of intervention (4 weeks)
Participants will take the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.
Time frame: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS anxiety prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.
Time frame: Baseline to end of intervention (4 weeks)
During daily intervention sessions (audio), participants will be required to do a pre-intervention and post-intervention survey regarding their pain (REDCAP visual analog pain survey). The post-surveys will be compared to the pre-surveys to determine audio MP4's effect on participant pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.
Time frame: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS fatigue prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.
Time frame: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS anxiety prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.
Time frame: Baseline to end of intervention (4 weeks)
Scores from the daily pre and post pain surveys of each group with be compared to examine whether audio or VR had a greater impact on pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.
Time frame: Baseline to end of intervention (4 weeks)
Scores from the baseline and weekly PROMIS fatigue surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.
Time frame: Baseline to end of intervention (4 weeks)
Scores from the baseline and weekly PROMIS anxiety surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.
Time frame: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS depression prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.
Time frame: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS depression prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.
Time frame: Baseline to end of intervention (4 weeks)
Scores from the baseline and weekly PROMIS depression surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms
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