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NCT Number: NCT06506435

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Benjamin J Rich, MD

CONTACT

[email protected]

305-243-4200

Benjamin J Rich, MD

PRINCIPAL_INVESTIGATOR

Crystal Chen, PhD

CONTACT

[email protected]

305-243-4200

Crystal Chen, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven cancer
  • ≥18 years of age
  • Able to speak and read English and/or Spanish
  • Receiving radiotherapy at the University of Miami

Exclusion criteria

  • 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

Treatment and study plan

Two Dimensional (2D) Informational Video

Behavioral

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 Video

Behavioral

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 Video

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin J Rich, MD

CONTACT

[email protected]

305-243-4200

Crystal Chen, PhD

CONTACT

[email protected]

305-243-4200

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

RADIOACTIVE - Radiotherapy Patient Education With Virtual Reality

Acronym: RADIOACTIVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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