Virtual Reality Education Program to Reduce Anxiety During Radiation Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2020-04-14

Brief Summary

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The purpose of this study is to compare the efficacy of an immersive virtual reality (VR)-based education program with a form of patient education commonly provided by clinics (e.g., an educational video) at delivering education to breast cancer patients as they prepare for radiation therapy treatment. Self-evaluation questionnaires completed by participants will be used to measure changes in information needs and anxiety, stress, preparedness and satisfaction levels pre/post education between the VR-based education and video education groups in this study. Expanded access to the current VR-based education program will depend on licensing status for associated assets by interested parties.

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Detailed Description

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Breast cancer patients experience anxiety, potentially reaching levels that are considered clinically-relevant. Prior research in this area has described the information needs of breast cancer patients at different time points as they proceed through the radiotherapy treatment process. Of high importance seems to be addressing patients' information needs through sensory and procedural information as a mechanism of anxiety reduction.

The study team created an immersive VR-based education program that enables breast cancer patients to experience the procedure and emotions associated with radiation therapy prior to their actual treatment by offering controlled virtual exposure to the clinical environments involved in the treatment process. An educational video on the process of receiving radiation therapy is considered standard education at the majority of the clinical sites involved in this study.

Participants enrolled in this study will be randomly assigned to either the VR-based education group or the video education group. Participation in this project will provide insight into aspects of patient education that are most effective at reducing anxiety and stress levels and meeting patients' information needs when undergoing radiation therapy treatment.

Conditions

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Anxiety Stress Satisfaction, Patient Preparedness Information Needs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Video Education

Participants will receive video education on radiation therapy.

Group Type ACTIVE_COMPARATOR

Video Education

Intervention Type OTHER

Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video.

VR-based Education

Participants will receive VR-based education on radiation therapy.

Group Type EXPERIMENTAL

VR-based Education

Intervention Type OTHER

Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD).

Interventions

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Video Education

Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video.

Intervention Type OTHER

VR-based Education

Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient is 18 years of age or older
2. Patient is female
3. Patient has been diagnosed with breast cancer
4. Patient will be receiving whole breast radiation therapy without supraclavicular nodal irradiation
5. Patient is scheduled for an outpatient radiation oncology visit
6. Patient has the ability to understand a written informed consent document, and the willingness to sign it
7. Patient has the ability to complete a series of self-reported questionnaires

Exclusion Criteria

1. Non-English-speaking patients (as the VR education program includes English narration)
2. Patients with visual defects that affect their ability to watch a movie
3. Patients with auditory defects that affect their ability to listen with headphones
4. Patients who have worked in the field of radiation oncology as they would have previously undergone treatment-related education
5. Patients who have been treated previously with radiation oncology as they would have previously undergone treatment-related education
6. Patients that have been diagnosed with epilepsy, conditions causing seizures, or have any previous history of seizures because a very minute number of head-mounted display (HMD) users have experienced a seizure as a result of using the device
7. Patients with a reported history of cognitive disability as their ability to understand educational content may be impaired
8. Patients with a history of severe motion sickness because a side effect of using a HMD in a very small number of users is motion sickness symptoms
9. Patients with a pacemaker, hearing aid(s), and/or defibrillator, while patients with other types of electronic medical devices / implants will be assessed for eligibility on a case-by-case basis because there could be potential interference with the HMD

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No