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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10766 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I-4062924 | Other Identifier | Roswell Park Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (VR use) | Experimental | 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. |
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| Arm II (Standard care) | Active Comparator | Patients undergo standard care for the HSCT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Undergo standard care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Length of hospital stay up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Huizinga | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Interview | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Virtual Reality | Procedure | Use VR device |
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| Length of hospital stay up to 6 months |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| 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 |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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