Radiotherapy Patient Education With Virtual Reality (RADIOACTIVE)

December 12, 2025 updated by: Benjamin Rich, University of Miami

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Benjamin J Rich, MD
  • Phone Number: 305-243-4200
  • Email: brich@miami.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Benjamin J Rich, MD
        • Contact:
        • Principal Investigator:
          • Crystal Chen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline, up to 2 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline, up to 8 weeks
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)
Time Frame: baseline, up to 1 day (after intervention)
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
Time Frame: Baseline, up to 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin J Rich, MD, University of Miami
  • Principal Investigator: Crystal Chen, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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