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| ID | Type | Description | Link |
|---|---|---|---|
| JT 20764 | Other Identifier | JeffTrial Number |
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ViewRay (funding sponsor) bankruptcy
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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.
PRIMARY OBJECTIVE:
I. Examine patient reported comprehension of their tumor characteristics and treatment plan following 3D virtual reality review of their imaging.
SECONDARY OBJECTIVE:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At first on treatment visit (after starting radiation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Mueller, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Computed Tomography | Procedure | Undergo CT |
|
|
| Best Practice | Other | Review imaging on standard computer screen |
|
|
| Questionnaire Administration | Other | Complete questionnaire |
|
| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
|
| Computed Tomography | Procedure | Undergo CT |
|
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| Virtual Technology Intervention | Other | Review virtual reality images |
|
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| Questionnaire Administration | Other | Complete questionnaire |
|
| 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. |
| 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. | 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. | Baseline and at first on treatment visit (after starting radiation) |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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