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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01954 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00025461 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.
SECONDARY OBJECTIVES:
I. To evaluate whether there is a short-term effect of VR use in anxiety levels.
II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.
EXPLORATORY OBJECTIVE:
I. To assess participants' reported adverse effects associated with VR headset use.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients use VR during chemotherapy infusion on study.
GROUP 2: Patients use smartphone during chemotherapy infusion on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (VR) | Experimental | Patients use VR during chemotherapy infusion on study. |
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| Group 2 (Smartphone) | Active Comparator | Patients use smartphone during chemotherapy infusion on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in anxiety levels | Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder. | Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term difference in anxiety levels | Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety. | Before VR goggle use and immediately after chemotherapy infusion is complete |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan J Li | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| Telephone-Based Intervention |
| Behavioral |
Use smartphone |
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| Virtual Technology Intervention | Other | Use VR headset |
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| Participants' satisfaction with the VR device | Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data. | Immediately after chemotherapy infusion is complete |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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