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Active, not recruitingNCT06798701Updated Jul 16, 2026

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

An interventional study of Best Practice and Interview in Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, sponsored by Roswell Park Cancer Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm
03

In context

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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: Interview · Other: Survey Administration · Procedure: Virtual Reality

  • Active comparator
    Arm II (Standard care)

    Patients undergo standard care for the HSCT.

    Other: Best Practice · Other: Survey Administration

Interventions

  • OtherBest Practice

    Undergo standard care

    Also known as: standard of care, standard therapy

  • OtherInterview

    Ancillary studies

  • OtherSurvey Administration

    Ancillary studies

  • ProcedureVirtual Reality

    Use VR device

    Also known as: VR

06

What researchers measure

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 months

Secondary 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 months

07

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06798701
Lead sponsor
Roswell Park Cancer Institute
Responsible party
Sponsor
First posted
Jan 29, 2025
Start date
Mar 14, 2025
Primary completion
Jul 14, 2026
Completion
Aug 14, 2027 (estimated)
Last update
Jul 16, 2026

Study contacts

Heather Huizinga
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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