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

NCT05793957 | Completed

• 2 other identifiers: STUDY00025461NCI-2023-01954
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Breast Neoplasm; Malignant Head and Neck Neoplasm; Malignant Solid Neoplasm; Malignant Thoracic Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Short-term difference in anxiety levels

  Before VR goggle use and immediately after chemotherapy infusion is complete

• Participants' satisfaction with the VR device

  Immediately after chemotherapy infusion is complete

Study Arms (2)

Group 1 (VR)

EXPERIMENTAL

Patients use VR during chemotherapy infusion on study.

Other: Questionnaire Administration; Other: Virtual Technology Intervention

Group 2 (Smartphone)

ACTIVE COMPARATOR

Patients use smartphone during chemotherapy infusion on study.

Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Interventions

Questionnaire Administration OTHER

Ancillary studies

Group 1 (VR); Group 2 (Smartphone)

Telephone-Based Intervention BEHAVIORAL

Use smartphone

Group 2 (Smartphone)

Virtual Technology Intervention OTHER

Use VR headset

Also known as: Virtual Reality Intervention, Virtual Technology

Group 1 (VR)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ryan J Li

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 31, 2023
• Study Start: April 20, 2023
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)