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Recruiting NCT06506435

Radiotherapy Patient Education With Virtual Reality

No phase Interventional Anxiety Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Two Dimensional (2D) Informational Video, First-Person Virtual Reality Video, Third-Person Virtual Reality Video.
Who it may be relevant to
Registry conditions: Anxiety, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

RADIOACTIVE - Radiotherapy Patient Education With Virtual Reality

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI) [Time frame: Baseline, up to 2 weeks]
Secondary outcome measures (3)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06506435 · 20240355

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗