Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation

Symptom Management in the Bone Marrow Transplant Patient Population Using Virtual Reality

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Procedure: Virtual Reality; Other: Best Practice

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
      • Contact: Heather Huizinga; Phone Number: 716-845-5482; Email: Heather.Huizinga@RoswellPark.org
      • Principal Investigator: Heather Huizinga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (VR use); 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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Procedure: Virtual Reality; Use VR device; Other Names: VR
Active Comparator: Arm II (Standard care); Patients undergo standard care for the HSCT.	Other: Survey Administration; Ancillary studies; Other: Best Practice; Undergo standard care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Length of hospital stay up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Length of hospital stay up to 6 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Heather Huizinga, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Interviews as Topic; Standard of Care; Practice Guidelines as Topic
• Other Study ID Numbers: I-4062924 (Other Identifier: Roswell Park Cancer Institute); NCI-2024-10766 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes