Clinical trial NCT05793957: Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms
Official title: Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Breast Neoplasm
Malignant Head and Neck Neoplasm
Malignant Solid Neoplasm
Malignant Thoracic Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2023-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in anxiety levels
timeFrame: Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed
Secondary outcomes:
measure: Short-term difference in anxiety levels
timeFrame: Before VR goggle use and immediately after chemotherapy infusion is complete
measure: Participants' satisfaction with the VR device
timeFrame: Immediately after chemotherapy infusion is complete
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Ryan J Li
role: PRINCIPAL_INVESTIGATOR
References: