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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| ONC-LUN-2407 | Other Identifier | Atrium Health Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Atrium Health Wake Forest Baptist | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.
This is a randomized controlled trial that will assess the feasibility, acceptability, tolerability, and initial clinical efficacy of using a VR device during radiation therapy for participants with prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Participants will be randomized 2:1 to either the VR device intervention arm or the standard of care control arm.
Participants will undergo pre-study assessments, assessments before and after the first radiation treatment, every 6th radiation treatment, and at the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Other | Standard of care radiation therapy for prostate, lung, breast cancer without using the VR headset |
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| Virtual Reality intervention | Other | Participants will wear the VR headset (Quest 2 by Meta) during radiation therapy |
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| Radiation Therapists | Other | Providers that administer the VR intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care | Other | Radiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VR Use During Treatment | A binary variable (Yes/No) will be created for participants at the level of individual treatment visit to signify whether the participants wore the VR device for the duration of their treatment. | Periprocedural (each treatment visit) |
| VR Functionality | VR device functionality (0-2) will be determined at the level of individual treatment visit using the following criteria as determined by the participant and/or treatment staff: 0 = device not functional at any time during the treatment
| Periprocedural (each treatment visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety - Change over time | Generalized Anxiety Disorder 7-item (GAD-7) to assess pre-existing generalized anxiety and the 23-item Radiotherapy Experience Questionnaire (RTEQ) situational unease and situational repose subscales. | GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment) |
| Acceptability of Implementing VR |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment - Treatment Related Adverse Events | Total counts and grade of symptoms such as nausea, dizziness, seizures, blurred vision, fatigue, eye or muscle twitching, instability in posture, blackouts triggered by light flashes or patterns, and headache. | Periprocedural (each treatment visit) |
| Anxiety - Change over the course of treatment |
Patients:
Inclusion Criteria:
Exclusion Criteria:
Radiation Therapists:
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheri Whittington | Contact | 336-878-6107 | Sheri.Whittington@Advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Parker, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist Hayworth Cancer Center | Recruiting | High Point | North Carolina | 27262 | United States |
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| Virtual Reality Intervention | Other | Participants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy |
|
| Radiation Therapist Survey | Other | Radiation therapists will be asked about their experiences and proficiency with using the VR device. |
|
Radiation Therapist Survey (Administered to staff only) |
| At 36 months |
Single Item Anxiety Questionnaire |
| Periprocedural (first treatment, last treatment, weekly during treatment) |
| Anxiety - Change over the course of treatment | Anxiety evaluation with heart rate | Periprocedural (first treatment, last treatment, weekly during treatment) |
| Participant Satisfaction | VR Satisfaction Questionnaire | 4-6 weeks following randomization |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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