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Virtual Reality Education Program to Reduce Anxiety During Radiation Therapy

Primary Purpose

Anxiety, Stress, Satisfaction, Patient

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Video Education

VR-based Education

About this trial

This is an interventional other trial for Anxiety focused on measuring Patient education, Virtual reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Non-English-speaking patients (as the VR education program includes English narration)
Patients with visual defects that affect their ability to watch a movie
Patients with auditory defects that affect their ability to listen with headphones
Patients who have worked in the field of radiation oncology as they would have previously undergone treatment-related education
Patients who have been treated previously with radiation oncology as they would have previously undergone treatment-related education
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
Patients with a reported history of cognitive disability as their ability to understand educational content may be impaired
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
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

Sites / Locations

Froedtert & the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Video Education

VR-based Education

Arm Description

Participants will receive video education on radiation therapy.

Participants will receive VR-based education on radiation therapy.

Outcomes

Primary Outcome Measures

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.

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).

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).

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04029961

First Posted

July 15, 2019

Last Updated

April 14, 2021

Sponsor

Medical College of Wisconsin

Collaborators

Marquette University, Froedtert Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04029961

Brief Title

Virtual Reality Education Program to Reduce Anxiety During Radiation Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was suspended due to the COVID-19 pandemic. The study was then terminated to prevent inconsistencies in baseline anxiety for patients enrolled before vs after the COVID-19 pandemic.

Study Start Date

August 12, 2019 (Actual)

Primary Completion Date

April 14, 2020 (Actual)

Study Completion Date

April 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

Collaborators

Marquette University, Froedtert Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Stress, Satisfaction, Patient, Preparedness, Information Needs

Keywords

Patient education, Virtual reality

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Video Education

Arm Type

Active Comparator

Arm Description

Participants will receive video education on radiation therapy.

Arm Title

VR-based Education

Arm Type

Experimental

Arm Description

Participants will receive VR-based education on radiation therapy.

Intervention Type

Other

Intervention Name(s)

Video Education

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

VR-based Education

Intervention Description

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).

Primary Outcome Measure Information:

Title

Intra- and Inter-arm Differences in Pre-post Intervention Changes in Anxiety Using the State Trait Anxiety Inventory (STAI) for Adults Scores

Description

Time Frame