Clinical trial NCT06446115: Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
Official title: Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Neoplasm
Cancer
Keywords: Virtual Reality
Chemotherapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, randomized 1:1, pilot study.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in distress scores between pre- and post-intervention
timeFrame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
Secondary outcomes:
measure: Changes in pain scores between pre- and post-intervention
timeFrame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
measure: Changes in GAD-7 scores between pre- and post-intervention
timeFrame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
measure: Changes in CCVAS scores between pre- and post-intervention
timeFrame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
measure: Predictor of intervention efficacy: Age
timeFrame: Day 1
measure: Predictor of intervention efficacy: Race
timeFrame: Day 1
measure: Predictor of intervention efficacy: Ethnicity
timeFrame: Day 1
measure: Predictor of intervention efficacy: Martial Status
timeFrame: Day 1
measure: Predictor of intervention efficacy: Occupation
timeFrame: Day 1
measure: Predictor of intervention efficacy: Time since diagnosis
timeFrame: Day 1
measure: Predictor of intervention efficacy: Current chemotherapy regimen
timeFrame: Day 1
measure: Predictor of intervention efficacy: Time since therapy initiated
timeFrame: Day 1
measure: Predictor of intervention efficacy: Attitudes towards use of virtual reality
timeFrame: Day 1
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida, Maroone Cancer Center
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida, Maroone Cancer Center
name: Zeina Nahleh, MD FACP
role: PRINCIPAL_INVESTIGATOR
References: