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

NCT ID: NCT06798701

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2026-03-14

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Interview

Intervention Type: OTHER

Ancillary studies

Survey Administration

Intervention Type: OTHER

Ancillary studies

Virtual Reality

Intervention Type: PROCEDURE

Use VR device

Arm II (Standard care)

Patients undergo standard care for the HSCT.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Undergo standard care

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Undergo standard care

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Virtual Reality

Use VR device

Intervention Type: PROCEDURE

Other Intervention Names

standard of care; standard therapy; VR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Huizinga

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Heather Huizinga

Role: primary

Heather.Huizinga@RoswellPark.org

716-845-5482

Other Identifiers

NCI-2024-10766

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-4062924

Identifier Type: OTHER

Identifier Source: secondary_id

I-4062924

Identifier Type: -

Identifier Source: org_study_id