RecruitingInterventional

RADIOACTIVE - Radiotherapy Patient Education With Virtual Reality

NCT ID: NCT06506435Sponsor: University of MiamiLast updated: 2025-12-19

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.

Arms & interventions

BehavioralTwo 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.
BehavioralFirst-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.
BehavioralThird-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.

Outcome measures

Primary

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.
Time frame: Baseline, up to 2 weeks

Secondary

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

University of Miami

Miami, Florida, 33136

Recruiting

Benjamin J Rich, MD · Contact

305-243-4200 brich@miami.edu

Crystal Chen, PhD · Contact

305-243-4200 ccc257@miami.edu

Benjamin J Rich, MD · Principal Investigator

Crystal Chen, PhD · Principal Investigator