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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446115
• Other study ID #: CASE3124
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Zeina Nahleh, MD FACP
• Phone: (954) 659-5840
• Email: nahlehz[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Malignant Neoplasm
• Neoplasms

Intervention

Device:
• Virtual Reality
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.

Other:
• Preferred activity
Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.
• Questionnaires
Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida, Maroone Cancer Center	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in pain scores between pre- and post-intervention	A secondary endpoint is the change in pain scores between pre- and post-intervention to evaluate the effectiveness of immersive virtual reality in reducing pain using the Universal Pain Assessment Tool. The Universal Pain Assessment Tool is a widely used instrument that consists of a visual analogue scale used to assess pain intensity. It includes a pain intensity scale that ranges from 0 to 10.	Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
Secondary	Changes in GAD-7 scores between pre- and post-intervention	A secondary endpoint is the change in anxiety scores pre- and post-intervention to evaluate the effectiveness of immersive virtual reality in reducing anxiety using the Generalized Anxiety Disorder-7 item (GAD-7). The Generalized Anxiety Disorder-7 item (GAD-7) questionnaires will be used to assess self-reported anxiety. The GAD-7 questionnaire will be interpreted as follows: minimal anxiety (0-4 points); mild anxiety (5-9 points); moderate anxiety (10-14 points) and severe anxiety (15-21 points).	Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
Secondary	Changes in CCVAS scores between pre- and post-intervention	A secondary endpoint is the change in depression scores pre- and post-intervention to evaluate the effectiveness of immersive virtual reality in reducing depression symptoms. The Cleveland Clinic Analog Scale (CCVAS) for depressive symptoms questionnaire will be used to assess self-reported depression. The CCVAS uses a 0-10 Likert scale, where 10 means feeling very depressed and 0 means not feeling any depression.	Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
Secondary	Predictor of intervention efficacy: Age	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Age will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Race	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Race will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Ethnicity	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Ethnicity will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Martial Status	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Marital status will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Occupation	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Occupation will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Time since diagnosis	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Time-to-diagnosis will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Current chemotherapy regimen	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Participants' current chemotherapy regimen will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Time since therapy initiated	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. The "time since therapy was initiated" will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1
Secondary	Predictor of intervention efficacy: Attitudes towards use of virtual reality	A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Participant attitudes toward the use of virtual reality will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.	Day 1