Virtual Reality Software to Reduce Stress in Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy

Conditions
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Breast Cancer, Head and Neck Cancer

Intervention / Treatment
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* Other: Virtual Reality Session


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Virtual Reality Sessions<br>Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment. | Other: Virtual Reality Session<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who complete 2 VR sessions | Percentage of patients who complete 2 VR sessions will be calculated. | Up to 3 Months | 
| Proportion of patients reporting ease of use for VR sessions | Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information. | Up to 3 Months | 
| Proportion of overall adherence to radiation therapy | Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated. | Up to 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in state trait anxiety scale | Change in state trait anxiety scale from baseline to follow-up will be calculated | Up to 3 Months | 
| Change in brief symptom inventory | Change in brief symptom inventory scale from baseline to follow-up will be calculated | Up to 3 Months | 
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI) | Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated | Up to 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Radiation Therapy, Education, Distress, Stress