Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute
About this trial
This clinical trial compares the use of virtual reality to standard care for improving symptom management in patients undergoing hematopoietic stem cell transplantation (HSCT). Significant symptoms experienced by hospitalized HSCT patients include, but are not limited to, depression, tiredness, anxiety, drowsiness, lack of appetite, pain, and overall decreased quality of life and well-being. Virtual reality (VR) as an intervention can provide these patients with a much-needed escape from their reality and has proven results in clinical settings as a distraction therapy. VR technology targets the patient's auditory, visual, and physical contact/touch senses, and has been evidenced to improve depression, fatigue, anxiety, appetite, and pain. Virtual reality may improve symptom management in patients undergoing HSCT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥ 18 years old) admitted to Roswell Park on 5 North for planned hematopoietic stem cell transplantation (HSCT)
Must be alert and oriented (Glascow Coma Scale of 15, Nursing Universal Flowsheet) and able to consent to participate in the study
Expected to be admitted to Roswell Park inpatient unit for ≥ 1 week
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Disqualifiers
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant patients
Incarcerated patients
Trial design
Design model
Parallel
Treatments tested in this trial
Best Practice
Other interventionUndergo standard care
Interview
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Virtual Reality
Procedure/SurgeryUse VR device
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Arm I (VR use)Experimental treatment 3 interventions
Group B: Arm II (Standard care)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Difference in the trajectories of the mean Edmonston Symptom Assessment System Revised (ESAS-r) composite scores
Firstly, the pattern of ESAS-r scores over time will be graphically examined. To account for the within-individual correlations, a generalized linear mixed model with appropriate link function will be applied. The time is measured by the number of days after treatment start and will be considered as a continuous variable. The effect of interest is the time by group interaction. Significant interaction implies different trajectories of ESAS-r composite scores over time. If the nonlinear patterns were observed, appropriate transformation or analyses focusing on the linear region will be considered. All tests will be two sided at a significant level of 0.05. Scores of individual items will be compared using the same approach. False discovery rate will be controlled using Benjamini-Hochberg procedure. As complementary analyses, models with only surveys before or after the virtual reality will also be examined.
Time frame
Length of hospital stay up to 6 monthsSecondary outcomes
1
Counts of supportive medication administration
Will be compared between two arms using generalized linear mixed models with appropriate link functions. The types of medications will be summarized by counts and percentages for each arm. Pre-intervention counts will be compared to during-intervention counts. The types of supportive medications will also be examined (i.e. anxiolytic, antidepressant, analgesic or antiemetics). Medications include (but are not limited to) the following: hydromorphone, acetaminophen, lorazepam, ondansetron, prochlorperazine, trazodone, and tramadol.
Time frame
Length of hospital stay up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov