Virtual Reality Software to Reduce Stress in Cancer Patients (OU-SCC VR)

February 12, 2024 updated by: University of Oklahoma

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Virtual Reality Sessions
Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who complete 2 VR sessions
Time Frame: Up to 3 Months
Percentage of patients who complete 2 VR sessions will be calculated.
Up to 3 Months
Proportion of patients reporting ease of use for VR sessions
Time Frame: 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.
Up to 3 Months
Proportion of overall adherence to radiation therapy
Time Frame: Up to 3 Months
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.
Up to 3 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Christina Henson, MD, Stephenson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OU-SCC-Virtual Reality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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