AnxietyNCT04029961

Virtual Reality Education Program to Reduce Anxiety During Radiation Therapy

A study testing Video Education and VR-based Education in people with Anxiety and Stress, run by Medical College of Wisconsin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Anxiety, Stress, Satisfaction, Patient
What is being tested?: Video Education and VR-based Education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 12 Aug 2019to 14 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Anxiety, Stress, Satisfaction, Patient, Preparedness, Information Needs
Being tested: Video Education, VR-based Education
Keywords: Patient education, Virtual reality
Medical subject headings: Anxiety Disorders, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Video EducationOther
Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video.
VR-based EducationOther
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).

Study groups in NCT04029961
Study group	Role	What they receive
Video Education	Active comparator	Participants will receive video education on radiation therapy. Receives: Other: Video Education
VR-based Education	Experimental	Participants will receive VR-based education on radiation therapy. Receives: Other: VR-based Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 201914 Apr 2020

First posted23 Jul 2019
Study start12 Aug 2019
Primary completion14 Apr 2020
Study completion14 Apr 2020

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04029961
Sponsor's protocol ID: PRO00032593
Status last verified: Apr 2021
First submitted: 15 Jul 2019
Last updated: 10 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21664788
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.
PubMed 27906757
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.
PubMed 18036247
Spielberger, C. State-Trait Anxiety Inventory for Adults - Manual, Instrument and Scoring Guide. 2015 Consulting Psychologists Press, Inc. Mind Garden, Inc.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study for the Development and Implementation of a Virtual Reality-based Radiation Therapy Education and Anxiety Mitigation Program
ClinicalTrials.gov ID: NCT04029961
Acronym / sponsor ID: PRO00032593
Conditions: Anxiety, Stress, Satisfaction, Patient, Preparedness, Information Needs
Keywords: Patient education, Virtual reality
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 28 participants (actual)
Lead sponsor: Medical College of WisconsinUniversity, hospital or other
Collaborators: Marquette University, Froedtert Hospital
Study start: 12 Aug 2019 (actual)
Primary completion: 14 Apr 2020 (actual)
Study completion: 14 Apr 2020 (actual)
First posted: 23 Jul 2019 (actual)
Results: Posted 10 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Video Education	Active comparator	Other: Video EducationParticipants will receive video education on radiation therapy.
VR-based Education	Experimental	Other: VR-based EducationParticipants will receive VR-based education on radiation therapy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Video EducationPrior to their CT simulation, participants will receive education on radiation therapy in the form of a video.	Other	Video Education
VR-based EducationPrior 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).	Other	VR-based Education

Primary outcome

Intra- and Inter-arm Differences in Pre-post Intervention Changes in Anxiety Using the State Trait Anxiety Inventory (STAI) for Adults Scores
Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
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
Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
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
Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
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
Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
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
Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
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.

Results and safety

Results posted to the registry on 10 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Video Education	13	12
VR-based Education	13	12

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

Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session). Mean (Standard Deviation). Unit: score on a scale

Measure	Video Education n = 12	VR-based Education n = 12
STAI-Trait: Pre-education	34.17 (9.504)	32.75 (5.083)
STAI-State: Pre-education	35.42 (8.118)	37.17 (8.943)
STAI-State: Post-education	29.58 (9.434)	31.92 (6.908)
STAI-State: After radiation therapy	33.00 (10.41)	31.00 (7.897)

Video Education vs VR-based Education: p <0.05, multivariate regression

Primary outcome: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Stress Using the Visual Analog Scale for Stress Scores

Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session). Mean (Standard Deviation). Unit: score on a scale

Measure	Video Education n = 12	VR-based Education n = 12
Pre-education	25.17 (19.85)	35.83 (21.41)
Post-education	22.83 (22.93)	22.50 (17.25)
After radiation therapy	33.08 (30.70)	25.83 (18.69)

Video Education vs VR-based Education: p <0.05, multivariate regression

Primary outcome: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Preparedness Using the Visual Analog Scale for Preparedness Scores

Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session). Mean (Standard Deviation). Unit: score on a scale

Measure	Video Education n = 12	VR-based Education n = 12
Pre-education	63.50 (22.11)	51.25 (22.37)
Post-education	82.50 (21.73)	82.42 (14.59)
After radiation therapy	90.83 (11.04)	87.08 (19.36)

Video Education vs VR-based Education: p <0.05, multivariate regression

Primary outcome: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Satisfaction Using the Visual Analog Scale for Satisfaction Scores

Time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session). Mean (Standard Deviation). Unit: score on a scale

Measure	Video Education n = 12	VR-based Education n = 12
Pre-education	95.42 (6.557)	87.92 (11.96)
Post-education	95.42 (6.557)	91.25 (10.03)
After radiation therapy	95.83 (9.003)	89.17 (19.64)

Video Education vs VR-based Education: p <0.05, multivariate regression

Adverse events

Time frame: 32 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Video Education	0 of 12 (0%)	0 of 12 (0%)	0 of 12
VR-based Education	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): This study is based on aggregate data from a small sample size. There were elements of this study difficult to standardize, such as educational information patients acquired on RT from other sources. The Information Needs Scale instructions could be interpreted two ways. It became unclear later on in the study whether patients should have been rating items based on overall informational importance or current need to obtain information. Patients may have completed this portion differently.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21664788Halkett 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.
Background: PubMed 27906757Bekelis 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.
Background: PubMed 18036247Halkett 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.
BackgroundSpielberger, C. State-Trait Anxiety Inventory for Adults - Manual, Instrument and Scoring Guide. 2015 Consulting Psychologists Press, Inc. Mind Garden, Inc.
Patient Video by the American Society for Therapeutic Radiation Oncology (ASTRO)Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John LaDisa, PhD principal investigator

Medical College of Wisconsin

Monica Shukla, MD principal investigator

Medical College of Wisconsin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Video Education and VR-based Education in people with Anxiety and Stress, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra- and Inter-arm Differences in Pre-post Intervention Changes in Anxiety Using the State Trait Anxiety Inventory (STAI) for Adults Scores (time frame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04029961, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.