Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Malignant Neoplasm; Cancer

Treatments: Device: Virtual Reality; Other: Preferred activity; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT06446115

CASE3124

Details and patient eligibility

About

The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain.

Participants will:

• Be randomly assigned to one of two available groups (virtual reality or standard of care)

• Participations will only be during one chemotherapy session.

• Those assigned to virtual reality:

  • The research team will provide a virtual reality
  • The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns.
  • Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes

• Those assigned to the standard of care:

  • The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.

Full description

In recent decades, new cancer cases have consistently risen. Participants diagnosed with cancer commonly face psychological symptoms including distress, anxiety, and depression in addition to physical symptoms (i.e., pain). Importantly, these symptoms might be exacerbated during chemotherapy sessions. New innovative technological strategies have been under development to control the symptoms and improve quality of life. Immersive virtual reality (VR) is a simulated experience that enables participants to interact with an artificial three-dimensional visual and auditory environment. VR could be an innovative intervention to relieve psychological symptoms associated with chemotherapy.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Biopsy proven diagnosis of Cancer (any stage or type).
• Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis.
• Must have the ability to understand and the willingness to sign a written informed consent document
• Followed by a medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic.
• Ability to read and write in English or Spanish.

Exclusion criteria

• Age <18 years.
• No prior history of Cancer.
• Prior medical history of severe motion sickness.
• Prior medical history of seizures
• Pregnancy.
• Unable or unwilling to participate in the immersive Virtual Reality study at the Maroone Cancer Center

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Virtual reality

Experimental group

Description:

Participants will be asked to use a headset device during 15 to 30 minutes while receiving a chemotherapy infusion. Participants have the option to choose from different virtual reality setting depending on their preference (i.e., nature videos, meditations, interactive applications, among others).

Treatment:

Other: Questionnaires

Device: Virtual Reality

Standard of care

Active Comparator group

Description:

Participants will be asked to choose any activity of your preference during the chemotherapy session (i.e., watching tv, reading a book, listening to music or a podcast, etc.)

Treatment:

Other: Questionnaires

Other: Preferred activity