Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms

Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?

This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Malignant Thoracic Neoplasm; Malignant Head and Neck Neoplasm; Malignant Breast Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Virtual Technology Intervention; Behavioral: Telephone-Based Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.

SECONDARY OBJECTIVES:

I. To evaluate whether there is a short-term effect of VR use in anxiety levels.

II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.

EXPLORATORY OBJECTIVE:

I. To assess participants' reported adverse effects associated with VR headset use.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients use VR during chemotherapy infusion on study.

GROUP 2: Patients use smartphone during chemotherapy infusion on study.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute
      • Contact: Ryan J. Li; Phone Number: 503-494-5355; Email: lry@ohsu.edu
      • Principal Investigator: Ryan J. Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English.
• Older than 18 years of age, and younger than 89 years of age. All sexes/gender identities and members of all races and ethnic groups will be included.
• Planned to receive chemotherapy infusion for head and neck, breast, thoracic, and hematologic cancers at the Oregon Health & Science University (OHSU) South Waterfront Center for Health & Healing building 2 (there are no restrictions related to prior chemotherapy infusions or other cancer treatments).
• Chemotherapy treatment lasting at least 10 minutes.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• Social or psychiatric conditions that may interfere with compliance.
• Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset. This would limit the ability to utilize the VR headset.
• History of seizure or epilepsy.
• History of vertigo or persistent dizziness.
• Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators.
• Children.
• Pregnant women.
• Decisionally impaired adults.
• Prisoners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (VR); Patients use VR during chemotherapy infusion on study.	Other: Questionnaire Administration; Ancillary studies; Other: Virtual Technology Intervention; Use VR headset; Other Names: Virtual Reality Intervention; Virtual Technology
Active Comparator: Group 2 (Smartphone); Patients use smartphone during chemotherapy infusion on study.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Use smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in anxiety levels	Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.	Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term difference in anxiety levels	Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety.	Before VR goggle use and immediately after chemotherapy infusion is complete
Participants' satisfaction with the VR device	Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data.	Immediately after chemotherapy infusion is complete

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Ryan J Li, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: STUDY00025461 (Other Identifier: OHSU Knight Cancer Institute); NCI-2023-01954 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No