Malignant NeoplasmNCT06446115
Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
A study testing Virtual Reality, Preferred activity and Questionnaires in people with Malignant Neoplasm and Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Cancer
- What is being tested?
- Virtual Reality, Preferred activity and Questionnaires
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Florida, Maroone Cancer Center
Weston, Florida, 33331
About this study
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.
Read the 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.
- Conditions
- Malignant Neoplasm, Cancer
- Being tested
- Virtual Reality, Preferred activity, Questionnaires
- Keywords
- Virtual Reality, Chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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.
Preferred activityOther
Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.
QuestionnairesOther
Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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.) Receives: Other: Preferred activity; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start5 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, randomized 1:1, pilot study.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeina Nahleh, MD FACP, Principal investigator, Cleveland Clinic Florida, Maroone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446115
- Sponsor's protocol ID
- CASE3124
- Status last verified
- Apr 2026
- First submitted
- 29 May 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as this is a minimally invasive pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
- ClinicalTrials.gov ID
- NCT06446115
- Acronym / sponsor ID
- CASE3124
- Conditions
- Malignant Neoplasm, Cancer
- Keywords
- Virtual Reality, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized 1:1, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual Reality, Other: QuestionnairesParticipants 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). |
| Standard of care | Active comparator | Other: Preferred activity, Other: QuestionnairesParticipants 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Age <18 years.
- No prior history of Cancer.
- Prior medical history of severe motion sickness.
- Prior medical history of seizures
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual 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. | Device | Virtual reality |
| Preferred activityParticipants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy. | Other | Standard of care |
| QuestionnairesParticipants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA. | Other | Standard of care, Virtual reality |
Primary outcome
Change in distress scores between pre- and post-intervention
Time frame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours 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
12 secondary outcomes
Changes in pain scores between pre- and post-intervention
Time frame: 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
Time frame: 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
Time frame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
Predictor of intervention efficacy: Age
Time frame: Day 1
Predictor of intervention efficacy: Race
Time frame: Day 1
Predictor of intervention efficacy: Ethnicity
Time frame: Day 1
Predictor of intervention efficacy: Martial Status
Time frame: Day 1
Predictor of intervention efficacy: Occupation
Time frame: Day 1
Predictor of intervention efficacy: Time since diagnosis
Time frame: Day 1
Predictor of intervention efficacy: Current chemotherapy regimen
Time frame: Day 1
Predictor of intervention efficacy: Time since therapy initiated
Time frame: Day 1
Predictor of intervention efficacy: Attitudes towards use of virtual reality
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as this is a minimally invasive pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeina Nahleh, MD FACP principal investigator
Cleveland Clinic Florida, Maroone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality, Preferred activity and Questionnaires in people with Malignant Neoplasm and Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distress scores between pre- and post-intervention (time frame: Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.