AnxietyRADIOACTIVENCT06506435
Radiotherapy Patient Education With Virtual Reality
A study testing Two Dimensional (2D) Informational Video, First-Person Virtual Reality Video and Third-Person Virtual Reality Video in people with Anxiety and Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Two Dimensional (2D) Informational Video, First-Person Virtual Reality Video and Third-Person Virtual Reality Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cancer
- ≥18 years of age
- Able to speak and read English and/or Spanish
- Receiving radiotherapy at the University of Miami
Who cannot join
- Prior radiation therapy
- Pregnant or nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Patients unable to consent or are prisoners
- Participants with impaired decision-making capacity
- Any serious illness or medical condition that would compromise patient safety during virtual reality as judged by the treating physician
- Unwilling or unable to watch virtual reality video
- Unwilling to fill out survey forms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Benjamin J Rich, MD, 305-243-4200, brich@miami.edu
Crystal Chen, PhD, 305-243-4200, ccc257@miami.edu
About this study
Official title: 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.
- Being tested
- Two Dimensional (2D) Informational Video, First-Person Virtual Reality Video, Third-Person Virtual Reality Video
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Dimensional (2D) Informational VideoBehavioural
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.
First-Person Virtual Reality VideoBehavioural
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.
Third-Person Virtual Reality VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Informational Video | Active comparator | 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. Receives: Behavioral: Two Dimensional (2D) Informational Video |
| Virtual Reality: 1st Person Perspective | Experimental | 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. Receives: Behavioral: First-Person Virtual Reality Video |
| Virtual Reality: 3rd Person Perspective | Experimental | 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. Receives: Behavioral: Third-Person Virtual Reality Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 2 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start4 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Rich, University of Miami
- Investigators
- Benjamin J Rich, MD, Principal investigator, University of MiamiCrystal Chen, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506435
- Sponsor's protocol ID
- 20240355
- Acronym
- RADIOACTIVE
- Status last verified
- Dec 2025
- First submitted
- 11 Jul 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIOACTIVE - Radiotherapy Patient Education With Virtual Reality
- ClinicalTrials.gov ID
- NCT06506435
- Acronym / sponsor ID
- RADIOACTIVE / 20240355
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Informational Video | Active comparator | Behavioral: Two Dimensional (2D) Informational VideoParticipants in this group will watch a two-dimensional (2D) informational video that explains the radiation treatment process. Total participation is up to 8 weeks. |
| Virtual Reality: 1st Person Perspective | Experimental | Behavioral: First-Person Virtual Reality VideoParticipants 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. |
| Virtual Reality: 3rd Person Perspective | Experimental | Behavioral: Third-Person Virtual Reality VideoParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven cancer
- ≥18 years of age
- Able to speak and read English and/or Spanish
- Receiving radiotherapy at the University of Miami
Key exclusion criteria (8 listed)
- Prior radiation therapy
- Pregnant or nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Patients unable to consent or are prisoners
- Participants with impaired decision-making capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two Dimensional (2D) Informational VideoA 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. | Behavioural | Informational Video |
| First-Person Virtual Reality VideoA 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. | Behavioural | Virtual Reality: 1st Person Perspective |
| Third-Person Virtual Reality VideoA 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. | Behavioural | Virtual Reality: 3rd Person Perspective |
Primary outcome
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.
3 secondary outcomes
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, up to 8 weeks
Change in Radiation Oncology Knowledge Assessment Survey (ROKAS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin J Rich, MD principal investigator
University of Miami
Crystal Chen, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two Dimensional (2D) Informational Video, First-Person Virtual Reality Video and Third-Person Virtual Reality Video in people with Anxiety and Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin J Rich, MD (305-243-4200, brich@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI) (time frame: Baseline, up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.