Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Oklahoma
- Primary Endpoint
- Proportion of patients who complete 2 VR sessions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old
- •Must be able to read and speak English
- •Diagnosis of breast or head and neck cancer
- •Treatment plan includes radiotherapy within the next 2 months
- •Signed study-specific informed consent prior to study entry
Exclusion Criteria
- •Previous radiation therapy treatment
- •Neurologic deficits
- •Visual disorder
- •Neuro-psychiatric disorder
- •Use of neuro-psychiatric drugs
Arms & Interventions
Virtual Reality Sessions
Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment.
Intervention: Virtual Reality Session (Other)
Outcomes
Primary Outcomes
Proportion of patients who complete 2 VR sessions
Time Frame: 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
Time Frame: 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
Time Frame: Up to 3 Months
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.
Secondary Outcomes
- Change in brief symptom inventory(Up to 3 Months)
- Change in state trait anxiety scale(Up to 3 Months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)(Up to 3 Months)