Virtual Reality Software to Reduce Stress in Cancer Patients

Not Applicable

Withdrawn

• Conditions: Head and Neck Cancer; Breast Cancer
• Interventions: Other: Virtual Reality Session

• Registration Number: NCT05263648
• Lead Sponsor: University of Oklahoma

Brief Summary

The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.

Detailed Description

This study will involve patients who have been diagnosed with breast or head and neck cancer and are suitable to receive radiation therapy. It is a single arm pilot trial designed to provide information on the safety, feasibility, and impacts of incorporating virtual reality (VR) software into the treatment plan of patients receiving radiation therapy with the goal of increasing patient adherence to radiation therapy.

Patients will be provided with VR-based education sessions prior to and during the course of radiation therapy. Patients' emotional and social distress levels will be assessed with questionnaires to measure the impacts of the VR software. Patients will be in the study for up to 3 months during regular cancer care, but the total time for the study procedures is anticipated to be 2-4 hours in total. Results from this study will be for research only and will not impact treatment decisions.

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2023-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 18 years old
2. Must be able to read and speak English
3. Diagnosis of breast or head and neck cancer
4. Treatment plan includes radiotherapy within the next 2 months
5. Signed study-specific informed consent prior to study entry

Exclusion Criteria

1. Previous radiation therapy treatment
2. Neurologic deficits
3. Visual disorder
4. Neuro-psychiatric disorder
5. Use of neuro-psychiatric drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Sessions	Virtual Reality Session	Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who complete 2 VR sessions	Up to 3 Months	Percentage of patients who complete 2 VR sessions will be calculated.
Proportion of patients reporting ease of use for VR sessions	Up to 3 Months	Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.
Proportion of overall adherence to radiation therapy	Up to 3 Months	Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.

Secondary Outcome Measures

Name	Time	Method
Change in brief symptom inventory	Up to 3 Months	Change in brief symptom inventory scale from baseline to follow-up will be calculated
Change in state trait anxiety scale	Up to 3 Months	Change in state trait anxiety scale from baseline to follow-up will be calculated
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)	Up to 3 Months	Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated