Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04029961
Other study ID # PRO00032593
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 12, 2019
Est. completion date April 14, 2020

Study information

Verified date April 2021
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date April 14, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
Medical College of Wisconsin Froedtert Hospital, Marquette University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A