Virtual Reality Software to Reduce Stress in Cancer Patients

Breast Cancer Clinical Trial

— OU-SCC VR  

Official title:

Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05263648
• Other study ID #: OU-SCC-Virtual Reality
• Status: Withdrawn
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Virtual Reality Session
VR-based education sessions will be used to influence patients' perceived emotional and social distress while undergoing radiation therapy (RT). Emotional and social distress levels will be evaluated using questionnaires at baseline (prior to the first VR experience), at completion of RT, and at 30-60 days post RT.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who complete 2 VR sessions	Percentage of patients who complete 2 VR sessions will be calculated.	Up to 3 Months
Primary	Proportion of patients reporting ease of use for VR sessions	Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.	Up to 3 Months
Primary	Proportion of overall adherence to radiation therapy	Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.	Up to 3 Months
Secondary	Change in state trait anxiety scale	Change in state trait anxiety scale from baseline to follow-up will be calculated	Up to 3 Months
Secondary	Change in brief symptom inventory	Change in brief symptom inventory scale from baseline to follow-up will be calculated	Up to 3 Months
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)	Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated	Up to 3 Months