Virtual Reality Software to Reduce Stress in Cancer Patients

NCT ID: NCT05263648

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-09-30

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.

Conditions

Breast Cancer; Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual Reality Sessions

Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment.

Group Type: OTHER

Virtual Reality Session

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Henson, MD

Role: PRINCIPAL_INVESTIGATOR

Stephenson Cancer Center

Other Identifiers

OU-SCC-Virtual Reality

Identifier Type: -

Identifier Source: org_study_id