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

NCT06446115 | Completed DMC

• 1 other identifier: CASE3124
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm; Cancer

Keywords

Virtual Reality; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in distress scores between pre- and post-intervention

  The primary endpoint is the distress score change between pre- and post-intervention to evaluate the effectiveness of immersive virtual reality during chemotherapy sessions in reducing distress in participants with high levels of distress from baseline diagnosed with any type of Cancer, using The NCCN Distress Thermometer. This is a single-item questionnaire used to screen for psychological distress in participants. It consists of a simple scale ranging from 0 to 10, where participants rate their level of distress. A score of 5 or more on the NCCN Distress Thermometer indicates moderate to severe psychological distress

  Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention

Secondary Outcomes (12)

• Changes in pain scores between pre- and post-intervention

  Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention

• Changes in GAD-7 scores between pre- and post-intervention

  Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention

• Changes in CCVAS scores between pre- and post-intervention

  Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention

• Predictor of intervention efficacy: Age

  Day 1

• Predictor of intervention efficacy: Race

  Day 1

Study Arms (2)

Virtual reality

EXPERIMENTAL

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).

Device: Virtual Reality; Other: Questionnaires

Standard of care

ACTIVE COMPARATOR

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.)

Other: Preferred activity; Other: Questionnaires

Interventions

Virtual Reality DEVICE

Virtual Reality Headset applied to the participants during chemotherapy session. Participants select their preferred virtual reality experience (i.e., nature videos, meditations, interactive applications, etc). Virtual reality (VR) by definition, is a simulated experience consisting of an experiential environment created by hardware and software technology capable of provoking sensations of real experiences. It can be further divided into 1) immersive; 2) semi-immersive; and 3) non-immersive. Immersive VR employs head-mounted display (HMD) system technology to separate users from their surroundings and engage in real-time with a three-dimensional environment generated by a computer.

Virtual reality

Preferred activity OTHER

Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.

Standard of care

Questionnaires OTHER

Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.

Standard of care; Virtual reality

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Florida, Maroone Cancer Center

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zeina Nahleh, MD FACP

  Cleveland Clinic Florida, Maroone Cancer Center

  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: SPONSOR

Model Details: This is a two-arm, randomized 1:1, pilot study.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 6, 2024
• Study Start: November 5, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)