Clinical trial NCT04029961: 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
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Stress
Satisfaction, Patient
Preparedness
Information Needs
Keywords: Patient education
Virtual reality
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
name: Froedtert Hospital
First posted: 2019-07-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Anxiety Using the State Trait Anxiety Inventory (STAI) for Adults Scores
timeFrame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
measure: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Stress Using the Visual Analog Scale for Stress Scores
timeFrame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
measure: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Preparedness Using the Visual Analog Scale for Preparedness Scores
timeFrame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
measure: Intra- and Inter-arm Differences in Pre-post Intervention Changes in Satisfaction Using the Visual Analog Scale for Satisfaction Scores
timeFrame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
measure: 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
timeFrame: Directly pre/post education (education appointment), directly following first radiation therapy (RT) treatment (first RT session)
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: John LaDisa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Monica Shukla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Spielberger, C. State-Trait Anxiety Inventory for Adults - Manual, Instrument and Scoring Guide. 2015 Consulting Psychologists Press, Inc. Mind Garden, Inc.