Virtual Reality Education Program to Reduce Anxiety During Radiation Therapy

NCT04029961 | Terminated Results

• 1 other identifier: PRO00032593
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Patient education; Virtual reality

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

Video Education

ACTIVE COMPARATOR

Participants will receive video education on radiation therapy.

Other: Video Education

VR-based Education

EXPERIMENTAL

Participants will receive VR-based education on radiation therapy.

Other: VR-based Education

Interventions

Video Education OTHER

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

Video Education

VR-based Education 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).

VR-based Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator
• Froedtert Hospital: collaborator

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (4)

• 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.

  PMID: 21664788 BACKGROUND

• 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.

  PMID: 27906757 BACKGROUND

• 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.

  PMID: 18036247 BACKGROUND

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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: John LaDisa
• Organization: Medical College of Wisconsin

jladisa@mcw.edu

414-288-6739

Study Officials

• John LaDisa, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Monica Shukla, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Biomedical Engineering

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 23, 2019
• Study Start: August 12, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: May 10, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)