Breast Cancer, Head and Neck Cancer
Conditions
Keywords
Virtual Reality, Radiation Therapy, Education, Distress, Stress
Brief summary
The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.
Detailed description
This study will involve patients who have been diagnosed with breast or head and neck cancer and are suitable to receive radiation therapy. It is a single arm pilot trial designed to provide information on the safety, feasibility, and impacts of incorporating virtual reality (VR) software into the treatment plan of patients receiving radiation therapy with the goal of increasing patient adherence to radiation therapy. Patients will be provided with VR-based education sessions prior to and during the course of radiation therapy. Patients' emotional and social distress levels will be assessed with questionnaires to measure the impacts of the VR software. Patients will be in the study for up to 3 months during regular cancer care, but the total time for the study procedures is anticipated to be 2-4 hours in total. Results from this study will be for research only and will not impact treatment decisions.
Interventions
VR-based education sessions will be used to influence patients' perceived emotional and social distress while undergoing radiation therapy (RT). Emotional and social distress levels will be evaluated using questionnaires at baseline (prior to the first VR experience), at completion of RT, and at 30-60 days post RT.
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Must be able to read and speak English 3. Diagnosis of breast or head and neck cancer 4. Treatment plan includes radiotherapy within the next 2 months 5. Signed study-specific informed consent prior to study entry
Exclusion criteria
1. Previous radiation therapy treatment 2. Neurologic deficits 3. Visual disorder 4. Neuro-psychiatric disorder 5. Use of neuro-psychiatric drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who complete 2 VR sessions | Up to 3 Months | Percentage of patients who complete 2 VR sessions will be calculated. |
| Proportion of patients reporting ease of use for VR sessions | Up to 3 Months | Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information. |
| Proportion of overall adherence to radiation therapy | Up to 3 Months | Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in state trait anxiety scale | Up to 3 Months | Change in state trait anxiety scale from baseline to follow-up will be calculated |
| Change in brief symptom inventory | Up to 3 Months | Change in brief symptom inventory scale from baseline to follow-up will be calculated |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI) | Up to 3 Months | Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated |
Outcome results
None listed