Virtual Reality Education Program to Reduce Anxiety During Radiation Therapy

Pilot Study for the Development and Implementation of a Virtual Reality-based Radiation Therapy Education and Anxiety Mitigation Program

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.

Study Overview

• Status: Terminated
• Conditions: Stress; Anxiety; Satisfaction, Patient; Information Needs; Preparedness
• Intervention / Treatment: Other: Video Education; Other: VR-based Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Video Education; Participants will receive video education on radiation therapy.	Other: Video Education; Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video.
Experimental: VR-based Education; Participants will receive VR-based education on radiation therapy.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra- and Inter-arm Differences in Pre-post Intervention Changes in Anxiety Using the State Trait Anxiety Inventory (STAI) for Adults Scores	The STAI was administered as a self-evaluation questionnaire at three time points. The STAI consists of two scales: one for measuring trait anxiety and one for measuring state anxiety. Both of the scales have ranges from 20 - 80, with higher scores representing higher anxiety.	Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
Intra- and Inter-arm Differences in Pre-post Intervention Changes in Stress Using the Visual Analog Scale for Stress Scores	The Visual Analog Scale for Stress was administered as a self-evaluation questionnaire at three time points. Participants indicated where they fell in terms of stress level from 0 (no stress at all) to 100 (most stressed ever).	Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
Intra- and Inter-arm Differences in Pre-post Intervention Changes in Preparedness Using the Visual Analog Scale for Preparedness Scores	The Visual Analog Scale for Preparedness was administered as a self-evaluation questionnaire at three time points. Participants indicated where they fell in terms of preparedness for their RT treatment from 0 (not prepared at all) to 100 (completely prepared).	Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
Intra- and Inter-arm Differences in Pre-post Intervention Changes in Satisfaction Using the Visual Analog Scale for Satisfaction Scores	The Visual Analog Scale for Satisfaction was administered at three time points. Participants indicated where they fell in terms of satisfaction from their experience with the radiation oncology department from 0 (not satisfied at all) to 100 (completely satisfied).	Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
Proportional Differences in Pre-post Intervention Changes in the "Met" Need Count Per Arm of Information Need Topics Related to Radiation Therapy Treatment Using the Information Needs Scale Scores	The Information Needs Scale was administered as a self-evaluation questionnaire at three time points. Participants were asked to indicate how important it was for them to have information on a set of items related to radiation therapy treatment from 1 (not important) to 9 (very important). Participants were also asked to indicate whether they felt their needed level of information for each item was met, partially met, or unmet at the time of questionnaire completion, which is reported here.	Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Marquette University; Froedtert Hospital
• Investigators: Principal Investigator: John LaDisa, PhD, Medical College of Wisconsin; Principal Investigator: Monica Shukla, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

• Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
• Halkett GK, Kristjanson LJ, Lobb E, Little J, Shaw T, Taylor M, Spry N. Information needs and preferences of women as they proceed through radiotherapy for breast cancer. Patient Educ Couns. 2012 Mar;86(3):396-404. doi: 10.1016/j.pec.2011.05.010. Epub 2011 Jun 12.
• Halkett GK, Kristjanson LJ. Validity and reliability testing of two instruments to measure breast cancer patients' concerns and information needs relating to radiation therapy. Radiat Oncol. 2007 Nov 25;2:43. doi: 10.1186/1748-717X-2-43.
• Spielberger, C. State-Trait Anxiety Inventory for Adults - Manual, Instrument and Scoring Guide. 2015 Consulting Psychologists Press, Inc. Mind Garden, Inc.

Helpful Links

• Patient Video by the American Society for Therapeutic Radiation Oncology (ASTRO)

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): April 14, 2020
• Study Completion (Actual): April 14, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Patient education; Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PRO00032593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No