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A Virtual Reality-based Radiation Therapy Education Program

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ClinicalTrials.gov Identifier: NCT04029961
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Marquette University
Froedtert Hospital
Information provided by (Responsible Party):
Carmen Bergom, Medical College of Wisconsin

Brief Summary:
The objective of this study is to compare the effectiveness of an immersive virtual reality (VR)-based education program with the 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 informational needs and anxiety, stress, preparedness and satisfaction levels pre/post education between the VR-based education and video education groups in this study.

Condition or disease Intervention/treatment Phase
Anxiety Stress Satisfaction, Patient Preparedness Informational Needs Other: Video Education Other: VR-based Education Not Applicable

Detailed Description:

Approximately 45 percent of breast cancer patients experience anxiety, potentially even reaching levels that are considered clinically-relevant. Prior research in this area has described the informational 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' informational 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' informational needs when undergoing radiation therapy treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study for the Development and Implementation of a Virtual Reality-based Radiation Therapy Education and Anxiety Mitigation Program
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Video Education
Participants will receive video education on radiation therapy.
Other: Video Education
Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video.

Experimental: VR-based Education
Participants will receive VR-based education on radiation therapy.
Other: 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).




Primary Outcome Measures :
  1. Mean difference in pre-post changes between study arms in 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 appointment) ]
    The STAI will be administered as a self-evaluation questionnaire at several 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.

  2. Mean difference in pre-post changes between study arms in Visual Analog Scale for Stress scores [ Time Frame: Directly pre/post education (education appointment), directly following first radiation therapy treatment (first RT appointment) ]
    The Visual Analog Scale for Stress will be administered as a self-evaluation questionnaire at several time points. Participants will indicate where they fall in terms of stress level from 0 (no stress at all) to 100 (most stressed ever).

  3. Mean difference in pre-post changes between study arms in Visual Analog Scale for Preparedness scores [ Time Frame: Directly pre/post education (education appointment), directly following first radiation therapy treatment (first RT appointment) ]
    The Visual Analog Scale for Preparedness will be administered as a self-evaluation questionnaire at several time points. Participants will indicate where they fall in terms of preparedness for their RT treatment from 0 (not prepared at all) to 100 (completely prepared).

  4. Mean difference in pre-post changes between study arms in Visual Analog Scale for Satisfaction scores [ Time Frame: Directly pre/post education (education appointment), directly following first radiation therapy treatment (first RT appointment) ]
    The Visual Analog Scale for Satisfaction will be administered at several time points. Participants will indicate where they fall in terms of satisfaction with the radiation oncology department from 0 (not satisfied at all) to 100 (completely satisfied).

  5. Mean difference in pre-post changes between study arms in Informational Needs Scale scores [ Time Frame: Directly pre/post education (education appointment), directly following first radiation therapy treatment (first RT appointment) ]
    The Informational Needs Scale will be administered as a self-evaluation questionnaire at several time points. Participants will indicate how important it is for them to have information on a set of items related to radiation therapy treatment from 1 (not important) to 9 (very important). Participants will also indicate whether they feel their needed level of information for each item has been met, partially met, or unmet.


Secondary Outcome Measures :
  1. After virtual reality (VR) program interview [ Time Frame: Directly following first radiation therapy treatment (first RT appointment) ]
    A questionnaire consisting of questions written specifically for this study and space for free-text responses regarding patients' perceptions of the VR program and potential improvements will be completed by participants assigned to the VR education group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029961


Contacts
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Contact: Carmen Bergom, MD, PhD 4148058900 cccto@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital and Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Cancer Center Clinical Trials Office    414-805-8900    cccto@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Marquette University
Froedtert Hospital
Investigators
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Principal Investigator: Carmen Bergom, MD, PhD Medical College of Wisconsin
Principal Investigator: John LaDisa, PhD Marquette University

Publications:
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Responsible Party: Carmen Bergom, Assistant Professor, Radiation Oncology and Pharmacology and Toxicology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04029961     History of Changes
Other Study ID Numbers: PRO00032593
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmen Bergom, Medical College of Wisconsin:
Patient education
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders