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Virtual Reality Software to Reduce Stress in Cancer Patients

Primary Purpose

Breast Cancer, Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Session
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Virtual Reality, Radiation Therapy, Education, Distress, Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Virtual Reality Sessions

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients who complete 2 VR sessions
Percentage of patients who complete 2 VR sessions will be calculated.
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.
Proportion of overall adherence to radiation therapy
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.

Secondary Outcome Measures

Change in state trait anxiety scale
Change in state trait anxiety scale from baseline to follow-up will be calculated
Change in brief symptom inventory
Change in brief symptom inventory 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)
Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated

Full Information

First Posted
February 21, 2022
Last Updated
August 7, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05263648
Brief Title
Virtual Reality Software to Reduce Stress in Cancer Patients
Official Title
Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Head and Neck Cancer
Keywords
Virtual Reality, Radiation Therapy, Education, Distress, Stress

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Sessions
Arm Type
Other
Arm Description
Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients who complete 2 VR sessions
Description
Percentage of patients who complete 2 VR sessions will be calculated.
Time Frame
Up to 3 Months
Title
Proportion of patients reporting ease of use for VR sessions
Description
Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.
Time Frame
Up to 3 Months
Title
Proportion of overall adherence to radiation therapy
Description
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.
Time Frame
Up to 3 Months
Secondary Outcome Measure Information:
Title
Change in state trait anxiety scale
Description
Change in state trait anxiety scale from baseline to follow-up will be calculated
Time Frame
Up to 3 Months
Title
Change in brief symptom inventory
Description
Change in brief symptom inventory scale from baseline to follow-up will be calculated
Time Frame
Up to 3 Months
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)
Description
Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated
Time Frame
Up to 3 Months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Study is accruing 10 males and 10 females (n=20) by self-identification. No other genders will be recruited.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Must be able to read and speak English Diagnosis of breast or head and neck cancer Treatment plan includes radiotherapy within the next 2 months Signed study-specific informed consent prior to study entry Exclusion Criteria: Previous radiation therapy treatment Neurologic deficits Visual disorder Neuro-psychiatric disorder Use of neuro-psychiatric drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lead Nurse
Phone
(405)-271-8777
Email
scc-iit-office@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Henson, MD
Organizational Affiliation
Stephenson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Henson, MD
Phone
405-271-3016
Ext
52473
Email
Christina-Henson@ouhsc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Software to Reduce Stress in Cancer Patients

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