Clinical trial NCT06798701: Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Symptom Management in the Bone Marrow Transplant Patient Population Using Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference in the trajectories of the mean Edmonston Symptom Assessment System Revised (ESAS-r) composite scores
timeFrame: Length of hospital stay up to 6 months
Secondary outcomes:
measure: Counts of supportive medication administration
timeFrame: Length of hospital stay up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Heather Huizinga
role: PRINCIPAL_INVESTIGATOR
References: