Radiotherapy Patient Education With Virtual Reality (RADIOACTIVE)

RADIOACTIVE - Radiotherapy Patient Education With Virtual Reality

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Anxiety
• Intervention / Treatment: Behavioral: Two Dimensional (2D) Informational Video; Behavioral: First-Person Virtual Reality Video; Behavioral: Third-Person Virtual Reality Video

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin J Rich, MD; Phone Number: 305-243-4200; Email: brich@miami.edu
• Study Contact Backup: Name: Crystal Chen, PhD; Phone Number: 305-243-4200; Email: ccc257@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Benjamin J Rich, MD; Phone Number: 305-243-4200; Email: brich@miami.edu
      • Principal Investigator: Benjamin J Rich, MD
      • Contact: Crystal Chen, PhD; Phone Number: 305-243-4200; Email: ccc257@miami.edu
      • Principal Investigator: Crystal Chen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Informational Video; Participants in this group will watch a two-dimensional (2D) informational video that explains the radiation treatment process. Total participation is up to 8 weeks.	Behavioral: Two Dimensional (2D) Informational Video; 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.
Experimental: Virtual Reality: 1st Person Perspective; Participants in this group will have a virtual reality experience presented from a first-person perspective. Participants will wear a Meta Quest Pro virtual reality headset, immersing themselves in a scenario that replicates the radiation treatment process. Total participation is up to 8 weeks.	Behavioral: First-Person Virtual Reality Video; 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.
Experimental: Virtual Reality: 3rd Person Perspective; Participants in this group will wear a Meta Quest Pro virtual reality headset and use virtual reality to observe the radiation treatment scenario from a standing position within the room, enabling them to witness both the CT scan and radiation machine from an external viewpoint. Total participation is up to 8 weeks.	Behavioral: Third-Person Virtual Reality Video; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety Inventory (STAI) is a brief and widely used self-assessment tool validated to measure anxiety in individuals undergoing medical therapy or other stressful experiences. The scale consists of 20 items, with separate scales for trait and state. Scores on the Likert scale, ranging from 0 to 4, provide an assessment of symptom severity in patients dealing with various medical conditions (state) as well as baseline status (trait). Higher scores indicate higher levels of anxiety.	Baseline, up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety Inventory (STAI) is a brief and widely used self-assessment tool validated to measure anxiety in individuals undergoing medical therapy or other stressful experiences. The scale consists of 20 items, with separate scales for trait and state. Scores on the Likert scale, ranging from 0 to 4, provide an assessment of symptom severity in patients dealing with various medical conditions (state) as well as baseline status (trait). Higher scores indicate higher levels of anxiety.	Baseline, up to 8 weeks
Change in Radiation Oncology Knowledge Assessment Survey (ROKAS)	Radiation Oncology Knowledge Assessment Survey (ROKAS) is a questionnaire designed to evaluate patient understanding of the radiotherapy treatment process. It consists of questions tailored to assess knowledge related to radiation therapy, including about procedures and potential side effects associated with treatment. ROKAS score ranges from 0-11 with higher scores indicating higher knowledge of radiation oncology.	baseline, up to 1 day (after intervention)
Change in Health-Related Quality of Life measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire	The absolute difference score on the FACT-G will be compared between the arms. The FACT-G is a 27-item questionnaire that covers four health-related quality of life (HR-QOL) sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. Higher scored indicate better HR-QOL.	Baseline, up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Benjamin J Rich, MD, University of Miami; Principal Investigator: Crystal Chen, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders
• Other Study ID Numbers: 20240355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No