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Trial Title:
Radiotherapy Patient Education with Virtual Reality
NCT ID:
NCT06506435
Condition:
Anxiety
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Two Dimensional (2D) Informational Video
Description:
A 30-minute informational video. The two dimensional (2D) video provides information
about the radiotherapy process. Participants will receive this one-time intervention
in-person, prior to treatment.
Arm group label:
Informational Video
Intervention type:
Behavioral
Intervention name:
First-Person Virtual Reality Video
Description:
A 30-minute virtual reality video, experienced through a headset, provides an immersive
portrayal of the radiotherapy process from a first-person perspective. Participants will
receive this one-time intervention in-person, prior to treatment.
Arm group label:
Virtual Reality: 1st Person Perspective
Intervention type:
Behavioral
Intervention name:
Third-Person Virtual Reality Video
Description:
A 30-minute virtual reality video, experienced through a headset, provides an immersive
portrayal of the radiotherapy process from a third-person perspective. Participants will
receive this one-time intervention in-person, prior to treatment.
Arm group label:
Virtual Reality: 3rd Person Perspective
Summary:
The purpose of this research study is to investigate the impact of virtual reality
experiences on individuals undergoing radiotherapy, aiming to assess whether this
immersive technology can reduce anxiety and enhance patient overall treatment
satisfaction. By comparing different virtual reality techniques and a standard
informational video, the study seeks to identify optimal strategies for leveraging
virtual reality to improve the patient experience during radiotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically proven cancer
2. ≥18 years of age
3. Able to speak and read English and/or Spanish
4. Receiving radiotherapy at the University of Miami
Exclusion Criteria:
1. Prior radiation therapy
2. Pregnant or nursing women
3. Men or women of childbearing potential who are unwilling to employ adequate
contraception
4. Patients unable to consent or are prisoners
5. Participants with impaired decision-making capacity
6. Any serious illness or medical condition that would compromise patient safety during
virtual reality as judged by the treating physician
7. Unwilling or unable to watch virtual reality video
8. Unwilling to fill out survey forms
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Benjamin J Rich, MD
Phone:
305-243-4200
Email:
brich@miami.edu
Contact backup:
Last name:
Crystal Chen, PhD
Phone:
305-243-4200
Email:
ccc257@miami.edu
Contact backup:
Last name:
Benjamin J Rich, MD
Contact backup:
Last name:
Crystal Chen, PhD
Start date:
December 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06506435
