Radiotherapy Patient Education With Virtual Reality

NCT06506435 | Recruiting

• 1 other identifier: 20240355
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)

  Baseline, up to 8 weeks

• Change in Radiation Oncology Knowledge Assessment Survey (ROKAS)

  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

  Baseline, up to 8 weeks

Study Arms (3)

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.

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.

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.

Behavioral: Third-Person Virtual Reality Video

Interventions

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.

Informational Video

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.

Virtual Reality: 3rd Person Perspective

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.

Virtual Reality: 1st Person Perspective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Benjamin J Rich, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Crystal Chen, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin J Rich, MD

CONTACT

305-243-4200; brich@miami.edu

Crystal Chen, PhD

CONTACT

305-243-4200; ccc257@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)