Hematopoietic and Lymphoid Cell NeoplasmNCT05600556
Virtual Reality for the Improvement of Patients Understanding of Disease and Treatment (MRgRT)
A study testing Magnetic Resonance Imaging, Computed Tomography and Best Practice in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This clinical trial explores if using virtual reality (VR) headsets will help to improve patient understanding of their disease and decrease anxiety about treatment. Three-dimensional (3D) images may help the patient visualize their tumor and location better and therefore understand potential side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Magnetic Resonance Imaging, Computed Tomography and Best Practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: above 18 years
- Participants must be histologically proven neoplasm
- Planned to undergo radiation treatment using the MR Linac
Who cannot join
- Inability to tolerate virtual reality headset
- Non-English speaking patients
- Pediatric patients are ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Role of Virtual Reality (VR) in Patient Experience When Used for Magnetic Resonance-Guided Radiation Therapy (MRgRT)
This clinical trial explores if using virtual reality (VR) headsets will help to improve patient understanding of their disease and decrease anxiety about treatment. Three-dimensional (3D) images may help the patient visualize their tumor and location better and therefore understand potential side effects. Visualizing a virtual representation of the magnetic resonance imaging (MRI) linear accelerator (Linac) may decrease treatment related anxiety.
Read the detailed description
PRIMARY OBJECTIVE:
- Examine patient reported comprehension of their tumor characteristics and treatment plan following 3D virtual reality review of their imaging.
SECONDARY OBJECTIVE:
- Examine patient reported treatment related anxiety prior to and following virtual reality (VR) simulation of the MRI Linac treatment process.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive two-dimensional (2D) image review using standard computer screen on study. Patients undergo MRI and computed tomography (CT) imaging at screening and on study.
COHORT II: Patients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study.
- Being tested
- Magnetic Resonance Imaging, Computed Tomography, Best Practice, Questionnaire Administration, Virtual Technology Intervention
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT
Best PracticeOther
Also called standard of care, standard therapy
Review imaging on standard computer screen
Questionnaire AdministrationOther
Complete questionnaire
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT
Virtual Technology InterventionOther
Also called Virtual Reality Intervention, Virtual Technology
Review virtual reality images
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (standard imaging) | Active comparator | Patients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study Receives: Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Other: Best Practice; Other: Questionnaire Administration |
| Cohort II (virtual reality) | Experimental | Patients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study Receives: Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Other: Virtual Technology Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in composite knowledge questionnaire score
Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Measured: At Baseline
Increase in composite knowledge questionnaire score
Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Measured: At first on treatment visit (after starting radiation)
Secondary outcomes (4)
General anxiety
Pre-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Measured: At Baseline
General anxiety
Post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Measured: At first on treatment visit (after starting radiation)
MRI specific anxiety
Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Measured: Baseline and after MRI scan at time of planning scan
Plan review understanding
Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Measured: Baseline and at first on treatment visit (after starting radiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Why it stopped: ViewRay (funding sponsor) bankruptcy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Mueller, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600556
- Sponsor's protocol ID
- 22C.714
- Other IDs
- JT 20764
- Status last verified
- May 2025
- First submitted
- 18 Oct 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Virtual Reality (VR) in Patient Experience When Used for Magnetic Resonance-Guided Radiation Therapy (MRgRT)
- ClinicalTrials.gov ID
- NCT05600556
- Acronym / sponsor ID
- 22C.714
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ViewRay (funding sponsor) bankruptcy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial explores if using virtual reality (VR) headsets will help to improve patient understanding of their disease and decrease anxiety about treatment. Three-dimensional (3D) images may help the patient visualize their tumor and location better and therefore understand potential side effects. Visualizing a virtual representation of the magnetic resonance imaging (MRI) linear accelerator (Linac) may decrease treatment related anxiety.
Detailed description
PRIMARY OBJECTIVE:
- Examine patient reported comprehension of their tumor characteristics and treatment plan following 3D virtual reality review of their imaging.
SECONDARY OBJECTIVE:
- Examine patient reported treatment related anxiety prior to and following virtual reality (VR) simulation of the MRI Linac treatment process.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive two-dimensional (2D) image review using standard computer screen on study. Patients undergo MRI and computed tomography (CT) imaging at screening and on study.
COHORT II: Patients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (standard imaging) | Active comparator | Procedure: Magnetic Resonance Imaging, Procedure: Computed Tomography, Other: Best Practice, Other: Questionnaire AdministrationPatients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study |
| Cohort II (virtual reality) | Experimental | Procedure: Magnetic Resonance Imaging, Procedure: Computed Tomography, Other: Virtual Technology Intervention, Other: Questionnaire AdministrationPatients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: above 18 years
- Participants must be histologically proven neoplasm
- Planned to undergo radiation treatment using the MR Linac
Key exclusion criteria (3 listed)
- Inability to tolerate virtual reality headset
- Non-English speaking patients
- Pediatric patients are ineligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Cohort I (standard imaging) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT | Procedure or surgery | Cohort I (standard imaging) |
| Best PracticeAlso: standard of care, standard therapyReview imaging on standard computer screen | Other | Cohort I (standard imaging) |
| Questionnaire AdministrationComplete questionnaire | Other | Cohort I (standard imaging) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Cohort II (virtual reality) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT | Procedure or surgery | Cohort II (virtual reality) |
| Virtual Technology InterventionAlso: Virtual Reality Intervention, Virtual TechnologyReview virtual reality images | Other | Cohort II (virtual reality) |
| Questionnaire AdministrationComplete questionnaire | Other | Cohort II (virtual reality) |
Primary outcome
Increase in composite knowledge questionnaire score
Time frame: At Baseline
Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
Increase in composite knowledge questionnaire score
Time frame: At first on treatment visit (after starting radiation)
Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.
4 secondary outcomes
General anxiety
Time frame: At Baseline
General anxiety
Time frame: At first on treatment visit (after starting radiation)
MRI specific anxiety
Time frame: Baseline and after MRI scan at time of planning scan
Plan review understanding
Time frame: Baseline and at first on treatment visit (after starting radiation)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Mueller, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Computed Tomography and Best Practice in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in composite knowledge questionnaire score (time frame: At Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.