Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVE: I. To determine the efficacy of VR for symptom management in the admitted HSCT patient population. SECONDARY OBJECTIVE: I. To examine the use of supportive medications for symptom management after HSCT while using VR. EXPLORATORY OBJECTIVE: I. To evaluate any limitations or barriers of the use of VR in the inpatient setting throughout the study. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients use the VR device to participate in applications related to relaxation such as mediation, art and nature, for up to 15 minutes, daily, while inpatient for standard of care HSCT. ARM II: Patients undergo standard care for the HSCT. After completion of study intervention, patients are followed up after discharge.
Interventions
OTHERBest Practice
Undergo standard care
OTHERInterview
Ancillary studies
OTHERSurvey Administration
Ancillary studies
PROCEDUREVirtual Reality
Use VR device
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Patients who are unwilling or unable to follow protocol requirements * Individuals that are prone to motion sickness, nausea, dizziness, history of seizure, potential for seizure, history of delirium, at risk for confusion, etc * Participants with audio and/or visual impairments that would preclude them from using a VR device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the trajectories of the mean Edmonston Symptom Assessment System Revised (ESAS-r) composite scores | Length of hospital stay up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Counts of supportive medication administration | Length of hospital stay up to 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeather Huizinga
Roswell Park Cancer Institute
Outcome results
None listed