Virtual Reality Therapy for Cancer-Treatment Associated Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ages 18-88
Cancer diagnosis (histology verified)
Had surgical intervention, completed chemotherapy or radiation for therapeutic purposes
Documented symptoms of cancer or cancer therapy including at least one of the following: pain, anxiety, sleep difficulty, fatigue, neuropathy
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Relievrx
DeviceThe 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
Other interventionAudio Mp4 modules ranging from 3-15 minutes with guided meditation.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Virtual reality armExperimental treatment 1 intervention
Group B: Audio Mp4 armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
VR effect on perceived pain
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)2
VR effect on perceived fatigue
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)3
VR effect on perceived anxiety
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)4
Audio effect on perceived pain
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)Sponsors and contacts
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Source ClinicalTrials.gov