Radiotherapy Patient Education with Virtual Reality

Not Applicable

Recruiting

• Conditions: Cancer; Anxiety

• Registration Number: NCT06506435
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Status Verified: 2024-12
• Study Start: 2024-12-04
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)	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 Outcome Measures

Name	Time	Method
Change in Radiation Oncology Knowledge Assessment Survey (ROKAS)	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.
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)	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.
Change in Health-Related Quality of Life measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States